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D003424: Crohn Dise

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (40)


Name (Synonyms) Correlation
drug3014 Ozanimod Wiki 0.39
drug5196 risankizumab IV Wiki 0.30
drug5197 risankizumab SC Wiki 0.30
Name (Synonyms) Correlation
drug528 BMS-986337 Placebo Wiki 0.26
drug3705 Risankizumab IV Wiki 0.26
drug3252 Placebo for Upadacitinib Wiki 0.26
drug4243 TAK-018 Wiki 0.26
drug3250 Placebo for Risankizumab IV Wiki 0.26
drug3153 Personalized ambulatory training Wiki 0.26
drug1257 Darvadstrocel Wiki 0.26
drug4800 [14C]-NT-814 Wiki 0.26
drug4827 anti-SARS-CoV-2 convalescent plasma Wiki 0.26
drug4805 [68Ga]Ga-DOTA-(RGD)2 PET/CT Wiki 0.26
drug3251 Placebo for Risankizumab SC Wiki 0.26
drug3706 Risankizumab SC Wiki 0.26
drug4912 daily room disinfection Wiki 0.26
drug4818 all treatment about COVID-2019 Wiki 0.26
drug4766 XatJove Anoia Aplication Wiki 0.26
drug2972 Ontamalimab Wiki 0.26
drug1440 Early rehabilitation Wiki 0.26
drug4580 Upadacitinib Wiki 0.26
drug4813 aerosol box Wiki 0.26
drug1415 ELISA Wiki 0.26
drug4244 TAK-018 Placebo Wiki 0.26
drug1217 Cytochrome P450 (CYP) Substrates Wiki 0.26
drug527 BMS-986337 Wiki 0.26
drug4174 Subacute rehabilitation Wiki 0.26
drug2636 Mindfulness training Wiki 0.26
drug5278 transparent sheet Wiki 0.26
drug4803 [14C]CC-90001 Wiki 0.26
drug5135 placebo for risankizumab IV Wiki 0.26
drug4817 airway management during sedation or general anesthesia Wiki 0.26
drug909 Cannabis, Medical Wiki 0.26
drug4815 after-each-case room disinfection Wiki 0.26
drug3704 Risankizumab Wiki 0.18
drug3551 RT-PCR Wiki 0.15
drug5134 placebo for risankizumab Wiki 0.15
drug4773 Yoga Wiki 0.13
drug1640 Famotidine Wiki 0.12
drug3195 Placebo Wiki 0.05

Correlated MeSH Terms (32)


Name (Synonyms) Correlation
D000070627 Chronic Traumatic Encephalopathy NIH 0.26
D005879 Tourette Syndrome NIH 0.26
D012008 Recurrence NIH 0.18
Name (Synonyms) Correlation
D001714 Bipolar Disorder NIH 0.18
D015212 Inflammatory Bowel Diseases NIH 0.17
D003092 Colitis NIH 0.16
D005402 Fistula NIH 0.15
D012640 Seizures NIH 0.15
D003093 Colitis, Ulcerative NIH 0.15
D006526 Hepatitis C NIH 0.15
D000690 Amyotrophic Lateral Sclerosis NIH 0.13
D000755 Anemia, Sickle Cell NIH 0.13
D016472 Motor Neuron Disease NIH 0.13
D007410 Intestinal Diseases NIH 0.13
D005356 Fibromyalgia NIH 0.12
D001927 Brain Diseases NIH 0.11
D000070642 Brain Injuries, Traumatic NIH 0.09
D010300 Parkinsonian NIH 0.08
D014456 Ulcer NIH 0.08
D001930 Brain Injuries, NIH 0.07
D059350 Chronic Pain NIH 0.07
D009103 Multiple Sclerosis NIH 0.06
D012598 Scoliosi NIH 0.06
D040921 Stress Disorders, Traumatic NIH 0.04
D014947 Wounds and Injuries NIH 0.04
D013313 Stress Disorders, Post-Traumatic NIH 0.04
D004194 Disease NIH 0.04
D013577 Syndrome NIH 0.02
D003141 Communicable Diseases NIH 0.02
D007239 Infection NIH 0.01
D045169 Severe Acute Respiratory Syndrome NIH 0.01
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (11)


Name (Synonyms) Correlation
HP:0100280 Crohn's disease HPO 0.93
HP:0100754 Mania HPO 0.18
HP:0002037 Inflammation of the large intestine HPO 0.17
Name (Synonyms) Correlation
HP:0002583 Colitis HPO 0.16
HP:0100279 Ulcerative colitis HPO 0.15
HP:0006802 Abnormal anterior horn cell morphology HPO 0.13
HP:0007354 Amyotrophic lateral sclerosis HPO 0.13
HP:0002242 Abnormal intestine morphology HPO 0.13
HP:0001250 Seizure HPO 0.12
HP:0001298 Encephalopathy HPO 0.11
HP:0012532 Chronic pain HPO 0.07

Clinical Trials

Navigate: Correlations   HPO

There are 15 clinical trials


1 Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

NCT03440385
Conditions
  1. Crohn Disease
Interventions
  1. Drug: Ozanimod
  2. Other: Placebo
MeSH:Crohn Dise Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with a CDAI score < 150

Time: Week 12

Secondary Outcomes

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.

Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline

Time: Week 12

Description: The SES-CD assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing.

Measure: Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50%

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50%

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50%

Time: Week 12

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points

Time: Up to approximately week 12

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50%

Time: Up to approximately week 12

Description: Global Histologic Disease Activity score is a measure of histologic inflammation.

Measure: Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000)

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 70 points

Time: Week 12

Description: Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10%

Time: Week 12

Description: The CDEIS assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50%

Time: Week 12

Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.

Measure: Proportion of adolescent subjects with clinical remission, defined as Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points

Time: Up to approximately week 12

Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.

Measure: Proportion of adolescent subjects with clinical response, defined as a decrease in PCDAI ≥ 15 points from baseline

Time: Up to approximately week 12

Description: T and B cell panels consisting of Treg cells, naïve T and B cells, memory cells and plasmablasts are evaluated for assessment of immune status.

Measure: Assessment of circulating lymphocyte concentration

Time: Up to approximately week 12

Description: Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.

Measure: Assessment of gene expression

Time: Up to approximately week 12

Description: Protein biomarkers such as high-density lipoprotein, C-reactive protein, fecal calprotectin, Immunoglobulin A (IgA) are measured in addition to assessing clinical endpoints to help evaluate disease activity.

Measure: Assessment of protein biomarker concentration

Time: Up to approximately week 12

Description: Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.

Measure: Assessment of pharmacogenetics

Time: Up to approximately week 12

Description: SARS-CoV-2 serology (anti-SARS-CoV-2 total or IgG) from serum samples are measured to support advancing the understanding of the impact of SARS-CoV-2 on ozanimod and Crohn's disease. It may also be used to support health authority requests for analysis and advancement of pharmacodiagnostic development to better target drugs to the right patients

Measure: Assessment of impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD

Time: Up to approximately week 12
2 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

NCT03104413
Conditions
  1. Crohn's Disease
Interventions
  1. Drug: placebo for risankizumab IV
  2. Drug: risankizumab SC
  3. Drug: risankizumab IV
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.

Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

Time: Week 12

Description: Endoscopic response defined as decrease from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).

Measure: Percentage of Participants With Endoscopic Response

Time: Week 12

Secondary Outcomes

Description: Clinical remission per average daily SF and average daily AP score.

Measure: Percentage of Participants With Clinical Remission

Time: Up to Week 12

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.

Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response

Time: Up to Week 12

Description: The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities.

Measure: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

Time: Week 12

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.

Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

Time: Week 4

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease. Endoscopic response defined as decrease from Baseline in SES-CD.

Measure: Percentage of Participants With CDAI Clinical Response and Endoscopic Response

Time: Week 12

Description: SF remission is defined using the average daily SF, and not worse than baseline.

Measure: Percentage of Participants With Stool Frequency (SF) Remission

Time: Week 12

Description: AP remission is defined using the average daily AP score, and not worse than baseline.

Measure: Percentage of Participants With Abdominal Pain (AP) Remission

Time: Week 12

Description: Endoscopic remission is defined as decrease in SES-CD as compared to baseline

Measure: Percentage of Participants With Endoscopic Remission

Time: Week 12

Description: Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.

Measure: Percentage of Participants With Enhanced Clinical Response

Time: Up to Week 12

Description: Endoscopic healing was assessed using SES-CD.

Measure: Percentage of Participants With Ulcer-Free Endoscopy

Time: Week 12

Description: Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

Measure: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline

Time: Week 12

Description: Participants with an event that results in admission to the hospital.

Measure: Percentage of Participants With CD-Related Hospitalization

Time: Up to Week 12

Description: Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.

Measure: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline

Time: Week 12
3 A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease

The study consists of 3 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991 - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic.

NCT03105102
Conditions
  1. Crohn's Disease
Interventions
  1. Drug: Placebo for Risankizumab SC
  2. Drug: Risankizumab IV
  3. Drug: Placebo for Risankizumab IV
  4. Drug: Risankizumab SC
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

Time: Week 52

Description: Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Endoscopic Response

Time: Week 52

Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Measure: Sub-Study 3: Number of Participants With Adverse Events

Time: Up to Week 220

Secondary Outcomes

Description: Clinical remission per average daily stool frequency (SF) and average daily AP score.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Clinical Remission

Time: Week 52

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0

Time: Week 52

Description: Endoscopic healing was assessed using SES-CD.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Ulcer-Free Endoscopy

Time: Week 52

Description: Endoscopic Remission is defined as SES-CD <= 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Endoscopic Remission

Time: Week 52

Description: The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.

Measure: Sub-Study 1 and Sub-Study 2: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

Time: Week 52

Description: Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline

Time: Week 52

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response

Time: Week 52

Description: SF Remission is defined by an average daily SF <= 2.8 and not worse than baseline.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Stool Frequency (SF) Remission

Time: Week 52

Description: AP Remission is defined by an average daily AP <= 1 and not worse than baseline.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Abdominal Pain (AP) Remission

Time: Week 52

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150. Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response

Time: Week 52

Description: Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Enhanced Clinical Response

Time: Week 52

Description: Deep remission defined as subjects with both clinical remission (per average daily SF and average daily AP score) and endoscopic healing (assessed using SES-CD).

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Deep Remission

Time: Week 52

Description: Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs) in Participants With Any EIMs at Baseline of Induction

Time: Week 52

Description: Participants with an event that results in admission to the hospital.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With CD-Related Hospitalizations

Time: Up to Week 52

Description: Participants without draining fistulas at Week 52 in subjects with draining fistulas at baseline of the induction study.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline of Induction

Time: Week 52

Description: Participants who underwent surgery related to CD.

Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Crohn's Disease (CD)-Related Surgeries

Time: Up to Week 52
4 A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

NCT03105128
Conditions
  1. Crohn's Disease
Interventions
  1. Drug: placebo for risankizumab
  2. Drug: risankizumab IV
  3. Drug: risankizumab SC
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.

Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

Time: Week 12

Description: Endoscopic response defined as decrease from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).

Measure: Percentage of Participants With Endoscopic Response

Time: Week 12

Secondary Outcomes

Description: Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.

Measure: Percentage of Participants With Clinical Remission

Time: Week 12

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.

Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response

Time: Up to Week 12

Description: The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities.

Measure: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

Time: Week 12

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.

Measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

Time: Week 4

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease. Endoscopic response defined as decrease from Baseline in SES-CD.

Measure: Percentage of Participants With CDAI Clinical Response and Endoscopic Response

Time: Week 12

Description: SF remission is defined using the average daily SF, and not worse than baseline.

Measure: Percentage of Participants With Stool Frequency (SF) Remission

Time: Week 12

Description: AP remission is defined using the average daily AP, and not worse than baseline.

Measure: Percentage of Participants With Abdominal Pain (AP) Remission

Time: Week 12

Description: Endoscopic remission is defined as decrease in SES-CD as compared to baseline

Measure: Percentage of Participants With Endoscopic Remission

Time: Week 12

Description: Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.

Measure: Percentage of Participants With Enhanced Clinical Response

Time: Up to Week 12

Description: Endoscopic healing was assessed using SES-CD.

Measure: Percentage of Participants With Ulcer-Free Endoscopy

Time: Week 12

Description: Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

Measure: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline

Time: Week 12

Description: Participants with an event that results in admission to the hospital.

Measure: Percentage of Participants With CD-Related Hospitalization

Time: Up to Week 12

Description: Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.

Measure: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline

Time: Week 12
5 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

NCT03345823
Conditions
  1. Crohn's Disease
Interventions
  1. Drug: Upadacitinib
  2. Drug: Placebo for Upadacitinib
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: CDAI is defined as CDAI <150.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)

Time: Week 52

Description: Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.

Measure: Sub-Study 1: Percentage of Participants with Endoscopic Response

Time: Week 52

Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.

Measure: Sub-Study 2: Number of Participants with Adverse Events

Time: Through Week 240

Secondary Outcomes

Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)

Time: Week 52

Description: Decrease of at least 100 points in CDAI from Baseline.

Measure: Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)

Time: Week 52

Description: Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).

Measure: Sub-Study 1: Percentage of Participants with Endoscopic Remission

Time: Week 52

Description: This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

Measure: Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.

Time: Week 52

Description: CDAI is defined as CDAI <150. Endoscopic remission is defined per SES-CD.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission

Time: Week 52

Description: CDAI remission is defined as CDAI < 150.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)

Time: Through Week 52

Description: The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

Measure: Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)

Time: Baseline (Week 0) to Week 52

Description: The FACIT-F questionnaire was developed to assess fatigue.

Measure: Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

Time: Baseline (Week 0) to Week 52

Description: This is assessed by reviewing participant's hospitalization data.

Measure: Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)

Time: Week 52

Description: EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

Measure: Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline

Time: Week 52
6 Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease

Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications. Sometimes, concerns about transfer of drugs to infants via breast milk lead the mothers to either avoid breastfeeding or stop their medication. Inflammatory Bowel Disease (IBD) is a chronic condition that is marked by an abnormal response of the body's immune system, and high levels of certain proteins that cause inflammation (Cytokines like Tumor Necrosis Factor-alpha or TNFα). A group of drugs called "biologics" target and stop these proteins from causing inflammation, and have been successfully used to treat this condition. Inflammatory proteins may be present in breast milk of healthy women in variable levels, and may play a role in development of infant's brain and immune system. This study is being conducted to investigate: - Concentration of some of the inflammatory proteins in breast milk of mothers with IBD and healthy controls - Interaction between these proteins and biologics in breast milk of women with IBD - Potential role of these proteins (and their interaction with biologics) on development of infant learning and memory function It has been presumed that concentrations of TNFα and some other cytokines are higher in breast milk of women with IBD, and the biologics can normalize these high levels. Due to precautions for COVID-19, the study now consists of only two mandatory study visits and two optional study visits. The mandatory visits include two home visits in the first 4 months postpartum to complete a participant questionnaire and collect a small sample of breast milk at each visit. The optional study visits consist of two visits at the Hospital for Sick Children for evaluation of learning and memory function of the infant at the ages of 12 and 18 months. Additionally, mothers will be required to complete for their infant subscales of The Ages and Stages Questionnaires®, Third Edition (ASQ®-3) either in person or over the telephone at the ages of 12 months and 18 months.

NCT03397108
Conditions
  1. Crohn's Disease
  2. Ulcerative Colitis
  3. Healthy Controls
MeSH:Crohn Disease Colitis Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases
HPO:Abnormal intestine morphology Colitis Crohn's disease Inflammation of the large intestine Ulcerative colitis

Primary Outcomes

Description: Multiplex assay will be used to measure TNFα and downstream chemokines including CCL2, CCL4, CCL7, CXCL10 in breast milk of two groups of participants (women with IBD and healthy controls). (The unit of measurement is the same for all these cytokines)

Measure: Levels of TNFα and its downstream chemokines (CCL2, CCL4, CCL7, and CXCL10) in breast milk of women with IBD and healthy controls by Multiplex assay

Time: 4 years

Secondary Outcomes

Description: ELISA assay will be used to measure total and free drug levels (bound and unbound to TNFα) in breast milk of lactating women with IBD. (The unit of measurement is the same for infliximab and adalimumab).

Measure: Milk concentration of TNFα inhibitors (infliximab, adalimumab) at different time-points between two doses of medication, in lactating women with IBD by ELISA assay

Time: 4 years

Description: The infants of women with IBD and healthy controls will be examined for cognitive development using Bayley-III

Measure: Scores on cognitive subset of Bayley Scales of Infant and Toddler development- Third Version (Bayley-III) in infants of healthy controls and women with IBD

Time: 4 years

Description: Infants of healthy controls and women with IBD will be examined for communication and problem-solving development using the ASQ®-3. This supplementary measure is intended to provide additional data as an alternative to Bayley test under unprecedented circumstances which preclude participants to complete Bayley test at the Hospital for Sick Children

Measure: Scores on the "Problem-solving" and "Communication" subscales of The Ages and Stages Questionnaire (ASQ®-3) in infants of healthy controls and women with IBD

Time: 4 years

Description: An estimation of the population distribution of anti-TNFα antibodies (infliximab and adalimumab) in breast milk of women with IBD will be made, using population pharmacokinetic modelling

Measure: Simulated/predicted profiles of TNFα inhibitors (infliximab, adalimumab) in breast milk in a large population of lactating women with IBD by population pharmacokinetic modelling

Time: 4 years
7 Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

NCT03440372
Conditions
  1. Crohn Disease
Interventions
  1. Drug: Ozanimod
  2. Other: Placebo
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with a CDAI score < 150

Time: Week 12

Secondary Outcomes

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.

Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline

Time: Week 12

Description: The SES-CD assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing.

Measure: Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50%

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50%

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50%

Time: Week 12

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points at week 12

Time: Up to approximately week 12

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50% at week 12.

Time: Up to approximately week 12

Description: Global Histologic Disease Activity score is a measure of histologic inflammation.

Measure: Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000)

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 70 points

Time: Week 12

Description: Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10%

Time: Week 12

Description: The CDEIS assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50%

Time: Week 12

Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.

Measure: Proportion of adolescent subjects with clinical remission, defined as Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points at week 12

Time: Up to approximately week 12

Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.

Measure: Proportion of adolescent subjects with clinical response, defined as a decrease in PCDAI ≥ 15 points from baseline

Time: Up to approximately week 12

Description: T and B cell panels consisting of Treg cells, naïve T and B cells, memory cells and plasmablasts are evaluated for assessment of immune status.

Measure: Assessment of circulating lymphocyte concentration

Time: Up to approximately week 12

Description: Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.

Measure: Assessment of gene expression

Time: Up to approximately week 12

Description: Protein biomarkers such as high-density lipoprotein, C-reactive protein, fecal calprotectin, Immunoglobulin A (IgA) are measured in addition to assessing clinical endpoints to help evaluate disease activity.

Measure: Assessment of protein biomarker concentration

Time: Up to approximately week 12

Description: Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.

Measure: Assessment of pharmacogenetics

Time: Up to approximately week 12

Description: SARS-CoV-2 serology (anti-SARS-CoV-2 total or IgG) from serum samples are measured to support advancing the understanding of the impact of SARS-CoV-2 on ozanimod and Crohn's disease. It may also be used to support health authority requests for analysis and advancement of pharmacodiagnostic development to better target drugs to the right patients

Measure: Assessment of impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD

Time: Up to approximately week 12
8 Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

NCT03440385
Conditions
  1. Crohn Disease
Interventions
  1. Drug: Ozanimod
  2. Other: Placebo
MeSH:Crohn Dise Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with a CDAI score < 150

Time: Week 12

Secondary Outcomes

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.

Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline

Time: Week 12

Description: The SES-CD assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing.

Measure: Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50%

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50%

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50%

Time: Week 12

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points

Time: Up to approximately week 12

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.

Measure: Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50%

Time: Up to approximately week 12

Description: Global Histologic Disease Activity score is a measure of histologic inflammation.

Measure: Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000)

Time: Week 12

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 70 points

Time: Week 12

Description: Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10%

Time: Week 12

Description: The CDEIS assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50%

Time: Week 12

Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.

Measure: Proportion of adolescent subjects with clinical remission, defined as Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points

Time: Up to approximately week 12

Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.

Measure: Proportion of adolescent subjects with clinical response, defined as a decrease in PCDAI ≥ 15 points from baseline

Time: Up to approximately week 12

Description: T and B cell panels consisting of Treg cells, naïve T and B cells, memory cells and plasmablasts are evaluated for assessment of immune status.

Measure: Assessment of circulating lymphocyte concentration

Time: Up to approximately week 12

Description: Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.

Measure: Assessment of gene expression

Time: Up to approximately week 12

Description: Protein biomarkers such as high-density lipoprotein, C-reactive protein, fecal calprotectin, Immunoglobulin A (IgA) are measured in addition to assessing clinical endpoints to help evaluate disease activity.

Measure: Assessment of protein biomarker concentration

Time: Up to approximately week 12

Description: Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.

Measure: Assessment of pharmacogenetics

Time: Up to approximately week 12

Description: SARS-CoV-2 serology (anti-SARS-CoV-2 total or IgG) from serum samples are measured to support advancing the understanding of the impact of SARS-CoV-2 on ozanimod and Crohn's disease. It may also be used to support health authority requests for analysis and advancement of pharmacodiagnostic development to better target drugs to the right patients

Measure: Assessment of impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD

Time: Up to approximately week 12
9 A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.

NCT03464097
Conditions
  1. Crohn Disease
Interventions
  1. Drug: Ozanimod
  2. Other: Placebo
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with a CDAI score of < 150

Time: Up to approximately week 52

Description: The SES-CD assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SESCD) score decrease from baseline of ≥ 50%

Time: Up to approximately week 52

Secondary Outcomes

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary

Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline

Time: Up to approximately week 52

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150

Time: Up to approximately week 52

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with a CDAI score < 150 at Week 52, while remaining corticosteroid-free in the prior 12 weeks

Time: Up to approximately week 52

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with a CDAI score of < 150 in subjects with a CDAI score < 150 at pre-randomization

Time: Up to approximately week 52

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

Measure: Proportion of subjects with a CDAI score of < 150 at Week 52 and at ≥ 80% of visits between Week 8 and Week 52, inclusive, in subjects with a CDAI score <150 at pre-randomization

Time: Up to approximately week 52

Description: Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥10%

Time: Up to approximately week 52

Description: Global Histologic Disease Activity score is a measure of histologic inflammation.

Measure: Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score [GHAS] changes (Geboes, 2000))

Time: Up to approximately week 52

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of endoscopic inflammation

Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline and an SES-CD decrease from baseline of ≥ 50%

Time: Up to approximately week 52

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50%

Time: Up to approximately week 52

Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline and an SES-CD ≤ 4 points and a SES-CD decrease ≥2 points

Time: Up to approximately week 52

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50%

Time: Up to approximately week 52

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50%

Time: Up to approximately week 52

Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of endoscopic inflammation

Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 70 points

Time: Up to approximately week 52

Description: Global Histologic Disease Activity score is a measure of histologic inflammation

Measure: Proportion of subjects with mucosal healing (SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points) and histologic improvement by GHAS or Robarts Histologic Index (RHI)

Time: Up to approximately week 52

Description: Time to relapse is defined as an increase in the CDAI score from Maintenance Day 1 of ≥ 100 points and a CDAI score > 220, SES-CD score ≥ 6 [or ≥ 4 if isolated ileal disease.

Measure: Time to relapse and exclusion of other causes of an increase in disease activity unrelated to underlying CD (eg, infections, change in medication)

Time: Up to approximately week 52

Description: The CDEIS assesses the degree of endoscopic inflammation.

Measure: Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50%

Time: Up to approximately week 52

Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.

Measure: Proportion of adolescent subjects with Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points

Time: Up to approximately week 52

Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.

Measure: Proportion of adolescent subjects with decrease from baseline in PCDAI score ≥15 points

Time: Up to approximately week 52

Description: The IBDQ is a self-administered, 32-item questionnaire concerning 4 dimensions of quality of life (Hlavaty, 2006).

Measure: Change from baseline (Induction) in Inflammatory Bowel Disease Questionnaire (IBDQ) scores (adult subjects only)

Time: Up to approximately week 52

Description: The medical outcomes SF-36 questionnaire provides a measure of the subject's health status. The SF-36 consists of either scaled scores, which are the weighted sums of the questions in their section.

Measure: Change from baseline (Induction) in 36-Item Short Form-36 Survey (SF-36) scores (adult subjects only)

Time: Up to approximately week 52

Description: The WPAI-CD (Reilly, 1993) is a validated, reliable and responsive instrument that assesses the impact of CD on work and activity during the past 7 days (Reilly, 2008).

Measure: Change from baseline (Induction) in Work Productivity and Activity Impairment questionnaire for Crohn's disease (WPAI-CD) scores (adult subjects only)

Time: Up to approximately week 52

Description: The EQ-5D (The EuroQol Group, 1990) is a validated, 6-item, self-administered instrument designed to measure generic health status.

Measure: Change from baseline (Induction) in EuroQol 5 dimensions questionnaire (EQ-5D) scores

Time: Up to approximately week 52

Description: The PGIC scale evaluates all aspects of patient's health and assesses if there has been an improvement or decline in clinical status. The self-report measure PGIC reflects a patient's belief about the efficacy of treatment.

Measure: Patient Global Impression of Change (PGIC) scores (adult subjects only)

Time: Up to approximately week 52

Description: Healthcare resource utilization will be evaluated in this study to assess the impact of CD and health-related outcomes (hospitalizations, emergency department or urgent care clinic visits, procedures, and physician visits).

Measure: Differences in CD-related hospitalizations, procedures, and surgery

Time: Up to approximately week 52

Description: T and B cell panels consisting of Treg cells, naïve T and B cells, memory cells and plasmablasts are evaluated for assessment of immune status.

Measure: Assessment of circulating lymphocyte concentration

Time: Up to approximately week 52

Description: Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.

Measure: Assessment of gene expression

Time: Up to approximately week 52

Description: Protein biomarkers such as high-density lipoprotein, C-reactive protein, fecal calprotectin, Immunoglobulin A (IgA) are measured in addition to assessing clinical endpoints to help evaluate disease activity.

Measure: Assessment of protein biomarker concentration

Time: Up to approximately week 52

Description: Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.

Measure: Assessment of pharmacogenetics

Time: Up to approximately week 52

Description: SARS-CoV-2 serology (anti-SARS-CoV-2 total or IgG) from serum samples are measured to support advancing the understanding of the impact of SARS-CoV-2 on ozanimod and Crohn's disease. It may also be used to support health authority requests for analysis and advancement of pharmacodiagnostic development to better target drugs to the right patients

Measure: Assessment of impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD

Time: Up to approximately week 52
10 A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305)

The purpose of this study is to evaluate the efficacy and safety of ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

NCT03559517
Conditions
  1. Crohn's Disease
Interventions
  1. Biological: Ontamalimab
  2. Other: Placebo
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

Measure: Number of Participants With Clinical Remission at Week 16

Time: Week 16

Description: Endoscopic response is measured by a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic response will be reported.

Measure: Number of Participants With Endoscopic Response at Week 16

Time: Week 16

Secondary Outcomes

Description: Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.

Measure: Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) at Week 16

Time: Week 16

Description: Enhanced endoscopic response is measured by a decrease from baseline in SES-CD (range from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.

Measure: Number of Participants With Enhanced Endoscopic Response at Week 16

Time: Week 16

Description: Clinical remission is determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

Measure: Number of Participants With Clinical Remission by 2-item Patient Reported Outcome (PRO) at Week 16

Time: Week 16

Description: Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.

Measure: Number of Participants With Clinical Response at Week 16

Time: Week 16

Description: Number of participants with both clinical remission by 2-item PRO as determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days and endoscopic response, as measured by a decrease in SES-CD (range from 0 to 56, with higher values indicating more severe disease).

Measure: Number of Participants With Clinical Remission and Endoscopic Response at Week 16

Time: Week 16

Description: Complete endoscopic healing at Week 16 as measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) will be assessed. Number of participants with complete endoscopic healing will be reported.

Measure: Number of Participants With Complete Endoscopic Healing at Week 16

Time: Week 16

Description: Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -100 at Week 16 will be reported.

Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -100 at Week 16

Time: Week 16

Description: Clinical response as measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -70 at Week 16 will be reported.

Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -70 at Week 16

Time: Week 16

Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11-point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

Measure: Number of Participants With Clinical Remission Over Time

Time: Baseline up to Week 16

Description: Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).

Measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 16

Time: Baseline, Week 16

Description: Endoscopic healing at Week 16 measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with endoscopic healing will be reported.

Measure: Number of Participants With Endoscopic Healing at Week 16

Time: Week 16

Description: The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life

Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score

Time: Baseline, Week 8, Week 12, up to Week 16, or early termination

Description: The Short form-36 health survey is used to assess HRQL. It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.

Measure: Change From Baseline in Short Form (SF)-36 at Week 16

Time: Baseline, Week 16

Description: Incidence of all cause hospitalizations will be assessed.

Measure: Incidence of Hospitalizations

Time: Baseline up to Week 32

Description: Incidence of total inpatient days will be assessed.

Measure: Incidence of Total Inpatient Days

Time: Baseline up to Week 32

Description: Incidence of Crohn's disease-related surgeries and other surgical procedures.

Measure: Incidence of Crohn's Disease (CD)-related and Other Surgeries

Time: Baseline up to Week 32
11 A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306)

The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

NCT03566823
Conditions
  1. Crohn's Disease
Interventions
  1. Biological: Ontamalimab
  2. Other: Placebo
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

Measure: Number of Participants With Clinical Remission at Week 16

Time: Week 16

Description: Endoscopic response is measured by a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic response will be reported.

Measure: Number of Participants With Endoscopic Response at Week 16

Time: Week 16

Secondary Outcomes

Description: Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.

Measure: Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) at Week 16

Time: Week 16

Description: Enhanced endoscopic response is measured by a decrease from baseline in SES-CD (range from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.

Measure: Number of Participants With Enhanced Endoscopic Response at Week 16

Time: Week 16

Description: Clinical remission is determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

Measure: Number of Participants With Clinical Remission by 2-item Patient Reported Outcome (PRO) at Week 16

Time: Week 16

Description: Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.

Measure: Number of Participants With Clinical Response at Week 16

Time: Week 16

Description: Number of participants with both clinical remission by 2-item PRO as determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days and endoscopic response, as measured by a decrease in SES-CD (range from 0 to 56, with higher values indicating more severe disease).

Measure: Number of Participants With Clinical Remission and Endoscopic Response at Week 16

Time: Week 16

Description: Complete endoscopic healing at Week 16 as measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) will be assessed. Number of participants with complete endoscopic healing will be reported.

Measure: Number of Participants With Complete Endoscopic Healing at Week 16

Time: Week 16

Description: Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -100 at Week 16 will be reported.

Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -100 at Week 16

Time: Week 16

Description: Clinical response as measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -70 at Week 16 will be reported.

Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -70 at Week 16

Time: Week 16

Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11-point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

Measure: Number of Participants With Clinical Remission Over Time

Time: Baseline up to Week 16

Description: Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).

Measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 16

Time: Baseline, Week 16

Description: Endoscopic healing at Week 16 measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with endoscopic healing will be reported.

Measure: Number of Participants With Endoscopic Healing at Week 16

Time: Week 16

Description: The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life

Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score

Time: Baseline, Week 8, Week 12, up to Week 16, or early termination

Description: The Short form-36 health survey is used to assess HRQL. It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.

Measure: Change From Baseline in Short Form (SF)-36 at Week 16

Time: Baseline, Week 16

Description: Incidence of all cause hospitalizations will be assessed.

Measure: Incidence of Hospitalizations

Time: Baseline up to Week 32

Description: Incidence of total inpatient days will be assessed.

Measure: Incidence of Total Inpatient Days

Time: Baseline up to Week 32

Description: Incidence of Crohn's disease-related surgeries and other surgical procedures.

Measure: Incidence of Crohn's Disease (CD)-related and Other Surgeries

Time: Baseline up to Week 32
12 A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease Recurrence

The purpose of this study is to evaluate the efficacy of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after a planned laparoscopic ileocecal resection with primary anastomosis.

NCT03943446
Conditions
  1. Crohn Disease
Interventions
  1. Drug: TAK-018
  2. Drug: TAK-018 Placebo
MeSH:Crohn Disease Recurrence
HPO:Crohn's disease

Primary Outcomes

Description: Endoscopic recurrence is defined as a Rutgeerts' score greater than or equal to (>=) i2. The Rutgeerts scoring is a 5-point scale used to assess endoscopic recurrence at the ileocolonic anastomosis and preanastomotic ileum. The scale ranges from i0 to i4; where i0 equal to (=) no lesions, i1= less than or equal to (<=) 5 aphthous ulcers, i2= greater than (>) 5 aphthous ulcers with normal mucosa between lesions or lesions are confined to the anastomosis, i3= diffuse aphthous ileitis with diffusely inflamed mucosa and i4= diffuse inflammation with larger ulcers, nodules, and/or narrowing.

Measure: Percentage of Participants With Endoscopic Recurrence of CD as Assessed by Rutgeerts Grading Scale at Week 26

Time: Week 26

Secondary Outcomes

Description: Stool samples will be collected for analysis of fecal calprotectin, a biomarker of intestinal inflammatory activity.

Measure: Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30

Time: Weeks 3, 6, 12, 18, 26 and 30

Measure: Ctrough: Observed Plasma Trough Concentrations of TAK-018

Time: Week 3 pre-dose and at multiple time points (up to 12 hours) post-dose
13 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

NCT03944447
Conditions
  1. Chronic Pain
  2. Chronic Pain Syndrome
  3. Chronic Pain Due to Injury
  4. Chronic Pain Due to Trauma
  5. Fibromyalgia
  6. Seizures
  7. Hepatitis C
  8. Cancer
  9. Crohn Disease
  10. HIV/AIDS
  11. Multiple Sclerosis
  12. Traumatic Brain Injury
  13. Sickle Cell Disease
  14. Post Traumatic Stress Disorder
  15. Tourette Syndrome
  16. Ulcerative Colitis
  17. Glaucoma
  18. Epilepsy
  19. Inflammatory Bowel Diseases
  20. Parkinson Disease
  21. Amyotrophic Lateral Sclerosis
  22. Chronic Traumatic Encephalopathy
  23. Anxiety
  24. Depression
  25. Insomnia
  26. Autism
  27. Opioid-use Disorder
  28. Bipolar Disorder
  29. Covid19
  30. SARS-CoV Infection
  31. COVID-19
  32. Corona Virus Infection
  33. Coronavirus
Interventions
  1. Drug: Cannabis, Medical
MeSH:Infection Communicable Diseases Hepatitis C Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkin Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Wounds and Injuries Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure

Primary Outcomes

Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).

Measure: Prevention of COVID-19

Time: Five years

Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).

Measure: Treatment of COVID-19

Time: Five years

Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

Measure: Treatment of Symptoms

Time: Five years

Secondary Outcomes

Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

Measure: Cannabis Impact on Quality of Life

Time: Five years

Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.

Measure: Cannabis Route and Dosing

Time: Five years

Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.

Measure: Monitoring Adverse Events

Time: Five years
14 Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula

The purpose of this study is to evaluate the long-term safety and efficacy of repeat administration of darvadstrocel in participants with Crohn's Disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and special situation reports (SSRs).

NCT04118088
Conditions
  1. Crohn's Disease
  2. Complex Perianal Fistula
Interventions
  1. Biological: Darvadstrocel
MeSH:Crohn Disease Fistula
HPO:Crohn's disease

Primary Outcomes

Description: An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE with an onset that occurs after receiving study drug.

Measure: Percentage of Participants with at Least 1 Treatment-Emergent Adverse Event (TEAE)

Time: From administration of repeat dose up to 156 weeks post-repeat administration

Description: An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Measure: Percentage of Participants with at Least 1 Treatment Emergent Serious Adverse Event (TESAE)

Time: From administration of repeat dose up to 156 weeks post-repeat administration

Description: An SSR includes pregnancy, any case in which a pregnant participant is exposed to a study product or in which a female participant or female partner of a male participant becomes pregnant following treatment with a study product. Exposure is considered either through maternal exposure or via semen following paternal exposure or infant exposure from breast milk.

Measure: Percentage of Participants with Special Situation Reports (SSRs)

Time: From administration of repeat dose up to 156 weeks post-repeat administration

Description: AESI includes immunogenicity/alloimmune reactions, hypersensitivity, transmission of infectious agents, tumorgenicity, ectopic tissue formation, medication errors.

Measure: Percentage of Participants with Adverse Event of Special Interest (AESI)

Time: From administration of repeat dose up to 156 weeks post-repeat administration

Secondary Outcomes

Description: Combined remission is defined as the closure of all treated external openings that were draining at baseline (i.e., baseline visit), despite gentle finger compression and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment.

Measure: Percentage of Participants who Achieve Combined Remission of Perianal Fistula(s)

Time: At Week 24 and at Week 156 post-repeat administration

Description: Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression.

Measure: Percentage of Participants who Achieve Clinical Remission

Time: At Weeks 6, 24, 52, 104, and 156 post-repeat administration

Description: Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression.

Measure: Percentage of Participants who Achieve Clinical Response

Time: At Weeks 6, 24, 52, 104, and 156 post-repeat administration

Description: Relapse is defined as reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed that were in the combined remission at Week 24 or the development of a collection >2 cm (in at least 2 dimensions) confirmed by centrally read MRI assessment.

Measure: Percentage of Participants with Relapse From Week 24 Combined Remission

Time: From Week 24 to Week 156 post-repeat administration

Description: Time to Relapse is defined as the time in days to reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed, relative to Week 24.

Measure: Time to Relapse

Time: From Week 24 to the Day of relapse post-repeat administration

Measure: Percentage of Participants with New Perianal Abscess in Treated Fistula

Time: Up to Week 156 post-repeat administration

Description: The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) discharge; (b) pain; (c) restriction of sexual activity; (d) type of perianal disease; and (e) degree of induration. Each item is graded on a 5-point scale ranging from no symptoms (score of 0) to severe symptoms (score of 4) and total range of score is from 0 to 20. Higher score means more severe disease.

Measure: Change From Baseline in Score of Discharge and Pain Items of Perianal Disease Activity Index (PDAI) Score

Time: Baseline to Weeks 6, 24, 52, 104, and 156 post-repeat administration
15 A Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study will evaluate the effect of repeated infusions of risankizumab on the pharmacokinetics of sensitive probe substrates of Cytochrome P450 (CYP) enzymes in participants with moderately to severely active UC or CD. Risankizumab is an investigational drug being developed to treat trial participants with inflammatory diseases such as UC and CD. The study is split into two periods. In Period 1, participants will receive single oral doses of CYP sensitive probes and in Period 2, participants will receive risankizumab followed by single oral doses of CYP sensitive probes. Around 20 adult participants with moderately to severely active CD or UC will be enrolled in the study across multiple sites worldwide. In Period 1, participants will receive oral doses of CYP sensitive probes on Day 1. In Period 2, participants will receive risankizumab by intravenous (IV) infusion on Days 1, 29 and 57 followed by oral CYP sensitive probes on Day 64. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.

NCT04254783
Conditions
  1. Ulcerative Colitis (UC)
  2. Crohn's Disease
Interventions
  1. Drug: Risankizumab
  2. Drug: Cytochrome P450 (CYP) Substrates
MeSH:Crohn Disease Colitis Colitis, Ulcerative Ulcer
HPO:Colitis Crohn's disease Ulcerative colitis

Primary Outcomes

Description: Maximum observed plasma concentration (Cmax) of Midazolam

Measure: Maximum Observed Plasma Concentration (Cmax) of Midazolam

Time: Up to 71 Days

Description: Time to maximum plasma concentration (Tmax) of Midazolam

Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Midazolam

Time: Up to 71 Days

Description: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration

Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Midazolam

Time: Up to 71 Days

Description: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

Measure: AUC From Time 0 to Infinity (AUCinf) of Midazolam

Time: Up to 71 Days

Description: Terminal phase elimination rate constant (β) for Midazolam

Measure: Terminal Phase Elimination Rate Constant (β) of Midazolam

Time: Up to 71 Days

Description: Terminal phase elimination half-life (t1/2) of Midazolam

Measure: Terminal Phase Elimination Half-Life (t1/2) of Midazolam

Time: Up to 71 Days

Description: Maximum observed plasma concentration (Cmax) of Caffeine

Measure: Maximum Observed Plasma Concentration (Cmax) of Caffeine

Time: Up to 71 Days

Description: Time to maximum plasma concentration (Tmax) of Caffeine

Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Caffeine

Time: Up to 71 Days

Description: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration

Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Caffeine

Time: Up to 71 Days

Description: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

Measure: AUC From Time 0 to Infinity (AUCinf) of Caffeine

Time: Up to 71 Days

Description: Terminal phase elimination rate constant (β) for Caffeine

Measure: Terminal Phase Elimination Rate Constant (β) of Caffeine

Time: Up to 71 Days

Description: Terminal phase elimination half-life (t1/2) of Caffeine

Measure: Terminal Phase Elimination Half-Life (t1/2) of Caffeine

Time: Up to 71 Days

Description: Maximum observed plasma concentration (Cmax) of Warfarin

Measure: Maximum Observed Plasma Concentration (Cmax) of Warfarin

Time: Up to 71 Days

Description: Time to maximum plasma concentration (Tmax) of Warfarin

Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Warfarin

Time: Up to 71 Days

Description: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration

Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Warfarin

Time: Up to 71 Days

Description: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

Measure: AUC From Time 0 to Infinity (AUCinf) of Warfarin

Time: Up to 71 Days

Description: Terminal phase elimination rate constant (β) for Warfarin

Measure: Terminal Phase Elimination Rate Constant (β) of Warfarin

Time: Up to 71 Days

Description: Terminal phase elimination half-life (t1/2) of Warfarin

Measure: Terminal Phase Elimination Half-Life (t1/2) of Warfarin

Time: Up to 71 Days

Description: Maximum observed plasma concentration (Cmax) of Omeprazole

Measure: Maximum Observed Plasma Concentration (Cmax) of Omeprazole

Time: Up to 71 Days

Description: Time to maximum plasma concentration (Tmax) of Omeprazole

Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Omeprazole

Time: Up to 71 Days

Description: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration

Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Omeprazole

Time: Up to 71 Days

Description: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

Measure: AUC From Time 0 to Infinity (AUCinf) of Omeprazole

Time: Up to 71 Days

Description: Terminal phase elimination rate constant (β) for Omeprazole

Measure: Terminal Phase Elimination Rate Constant (β) of Omeprazole

Time: Up to 71 Days

Description: Terminal phase elimination half-life (t1/2) of Omeprazole

Measure: Terminal Phase Elimination Half-Life (t1/2) of Omeprazole

Time: Up to 71 Days

Description: Maximum observed plasma concentration (Cmax) of Metoprolol

Measure: Maximum Observed Plasma Concentration (Cmax) of Metoprolol

Time: Up to 71 Days

Description: Time to maximum plasma concentration (Tmax) of Metoprolol

Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Metoprolol

Time: Up to 71 Days

Description: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration

Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Metoprolol

Time: Up to 71 Days

Description: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

Measure: AUC From Time 0 to Infinity (AUCinf) of Metoprolol

Time: Up to 71 Days

Description: Terminal phase elimination rate constant (β) for Metoprolol

Measure: Terminal Phase Elimination Rate Constant (β) of Metoprolol

Time: Up to 71 Days

Description: Terminal phase elimination half-life (t1/2) of Metoprolol

Measure: Terminal Phase Elimination Half-Life (t1/2) of Metoprolol

Time: Up to 71 Days

HPO Nodes


Reports

Data processed on December 13, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

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