Developed by Shray Alag, The Harker School
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Clinical Trials, and HPO
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There is one clinical trial.
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.
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 52Description: 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 52Description: 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 220Description: 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 52Description: 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 52Description: Endoscopic healing was assessed using SES-CD.
Measure: Sub-Study 1 and Sub-Study 2: Percentage of Participants With Ulcer-Free Endoscopy Time: Week 52Description: 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 52Description: 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 52Description: 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 52Description: 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 52Description: 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 52Description: 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 52Description: 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 52Description: 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 52Description: 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 52Description: 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 52Description: 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 52Description: 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 52Description: 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 52Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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