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    HP:0100280: Crohn's disease

    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 (30)


    Name (Synonyms) Correlation
    drug4441 convalescent plasma Wiki 0.37
    drug4711 risankizumab SC Wiki 0.35
    drug4710 risankizumab IV Wiki 0.35
    Name (Synonyms) Correlation
    drug4154 Upadacitinib Wiki 0.30
    drug4423 chlorine dioxide 3000 ppm Wiki 0.30
    drug1120 Cytochrome P450 (CYP) Substrates Wiki 0.30
    drug4424 chloroquine Wiki 0.30
    drug4655 placebo for risankizumab IV Wiki 0.30
    drug1261 Double-Blind NT-I7 Wiki 0.30
    drug2709 Ontamalimab Wiki 0.30
    drug2964 Placebo for Upadacitinib Wiki 0.30
    drug844 Cannabis, Medical Wiki 0.30
    drug2963 Placebo for Risankizumab SC Wiki 0.30
    drug3374 Risankizumab IV Wiki 0.30
    drug4433 comparison of sample collection methods Wiki 0.30
    drug3859 TAK-018 Wiki 0.30
    drug1157 Darvadstrocel Wiki 0.30
    drug4415 care as usual Wiki 0.30
    drug3375 Risankizumab SC Wiki 0.30
    drug2962 Placebo for Risankizumab IV Wiki 0.30
    drug3860 TAK-018 Placebo Wiki 0.30
    drug1262 Double-Blind Placebo Wiki 0.30
    drug4432 community health worker support Wiki 0.30
    drug4417 carotid-femoral pulse-wave velocity Wiki 0.30
    drug1248 Disulfiram Wiki 0.21
    drug3373 Risankizumab Wiki 0.21
    drug4654 placebo for risankizumab Wiki 0.17
    drug492 BNT162b1 Wiki 0.17
    drug4744 standard care Wiki 0.15
    drug2916 Placebo Wiki 0.05

    Correlated MeSH Terms (32)


    Name (Synonyms) Correlation
    D003424 Crohn Disease NIH 1.00
    D000070627 Chronic Traumatic Encephalopathy NIH 0.30
    D005879 Tourette Syndrome NIH 0.30
    Name (Synonyms) Correlation
    D005402 Fistula NIH 0.21
    D012008 Recurrence NIH 0.21
    D001714 Bipolar Disorder NIH 0.21
    D015212 Inflammatory Bowel Diseases NIH 0.20
    D003092 Colitis NIH 0.18
    D003093 Colitis, Ulcerative NIH 0.18
    D000690 Amyotrophic Lateral Sclerosis NIH 0.17
    D012640 Seizures NIH 0.17
    D016472 Motor Neuron Disease NIH 0.17
    D000755 Anemia, Sickle Cell NIH 0.15
    D007410 Intestinal Diseases NIH 0.15
    D005356 Fibromyalgia NIH 0.13
    D001927 Brain Diseases NIH 0.13
    D000070642 Brain Injuries, Traumatic NIH 0.10
    D010300 Parkinsonian NIH 0.10
    D014456 Ulcer NIH 0.09
    D001930 Brain Injuries, NIH 0.08
    D059350 Chronic Pain NIH 0.08
    D009103 Multiple Sclerosis NIH 0.07
    D012598 Scoliosi NIH 0.07
    D040921 Stress Disorders, Traumatic NIH 0.05
    D014947 Wounds and Injuries NIH 0.05
    D013313 Stress Disorders, Post-Traumatic NIH 0.05
    D004194 Disease NIH 0.05
    D013577 Syndrome NIH 0.03
    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 (10)


    Name (Synonyms) Correlation
    HP:0100754 Mania HPO 0.21
    HP:0002037 Inflammation of the large intestine HPO 0.20
    HP:0002583 Colitis HPO 0.18
    Name (Synonyms) Correlation
    HP:0100279 Ulcerative colitis HPO 0.18
    HP:0006802 Abnormal anterior horn cell morphology HPO 0.17
    HP:0007354 Amyotrophic lateral sclerosis HPO 0.17
    HP:0001250 Seizure HPO 0.15
    HP:0002242 Abnormal intestine morphology HPO 0.15
    HP:0001298 Encephalopathy HPO 0.13
    HP:0012532 Chronic pain HPO 0.08

    Clinical Trials

    Navigate: Correlations   HPO

    There are 11 clinical trials


    1 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
    2 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
    3 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
    4 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: 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 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 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. 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: 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 at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.

    Time: Week 52

    Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score. 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: 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: 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
    5 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
    6 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
    7 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
    8 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
    9 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 Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases 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
    10 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
    11 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 September 26, 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

    4,180 reports on interventions/drugs

    MeSH

    691 reports on MeSH terms

    HPO

    263 reports on HPO terms

    All Terms

    Alphabetical index of all Terms

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