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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03105128
Registration number
NCT03105128
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017
Titles & IDs
Public title
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
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Scientific title
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
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Secondary ID [1]
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0
2016-003123-32
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Secondary ID [2]
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M16-006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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0
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Crohn's disease
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - placebo for risankizumab
Treatment: Drugs - risankizumab IV
Treatment: Drugs - risankizumab SC
Experimental: Risankizumab Dose 1 (Period 1) - Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
Experimental: Risankizumab Dose 2 (Period 1) - Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
Placebo comparator: Placebo (Period 1) - Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Experimental: Risankizumab Dose 1 (Period 2) - Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Experimental: Risankizumab Dose 2 (Period 2) - Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Experimental: Risankizumab Dose 3 (Period 2) - Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Treatment: Drugs: placebo for risankizumab
Placebo for risankizumab administered by intravenous infusion
Treatment: Drugs: risankizumab IV
Risankizumab administered by intravenous infusion
Treatment: Drugs: risankizumab SC
Risankizumab administered by subcutaneous (SC) injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
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Assessment method [1]
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The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
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Timepoint [1]
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Week 12
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Primary outcome [2]
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US Specific: Percentage of Participants With Endoscopic Response
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Assessment method [2]
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The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
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Timepoint [2]
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Week 12
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Primary outcome [3]
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Global Outside of US: Percentage of Participants With Clinical Remission
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Assessment method [3]
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Clinical remission is defined as using the average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline.
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Timepoint [3]
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Week 12
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Primary outcome [4]
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Global Outside of US: Percentage of Participants With Endoscopic Response
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Assessment method [4]
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The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
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Timepoint [4]
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Week 12
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Secondary outcome [1]
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US Specific: Percentage of Participants With Clinical Remission
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Assessment method [1]
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Clinical remission is defined as using the average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
0
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US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
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Assessment method [2]
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Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.
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Timepoint [2]
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0
Week 4
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Secondary outcome [3]
0
0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
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Assessment method [3]
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Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.
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Timepoint [3]
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0
Week 12
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Secondary outcome [4]
0
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US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
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Assessment method [4]
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The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
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Timepoint [4]
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0
Week 12
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Secondary outcome [5]
0
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US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
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Assessment method [5]
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Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
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Timepoint [5]
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Week 4
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Secondary outcome [6]
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US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
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Assessment method [6]
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Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.
Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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US Specific: Percentage of Participants With Stool Frequency (SF) Remission
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Assessment method [7]
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Stool Frequency (SF) remission is defined as an average daily SF \<= 2.8 and not worse than baseline.
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
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Assessment method [8]
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The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score \<= 1 and not worse than baseline.
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Timepoint [8]
0
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Week 12
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Secondary outcome [9]
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US Specific: Percentage of Participants With Endoscopic Remission
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Assessment method [9]
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Endoscopic remission: SES-CD = 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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US Specific: Percentage of Participants With Enhanced Clinical Response
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Assessment method [10]
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Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
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Timepoint [10]
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Week 4
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Secondary outcome [11]
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US Specific: Percentage of Participants With Ulcer-Free Endoscopy
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Assessment method [11]
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Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore = 1 at Baseline
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Timepoint [11]
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Week 12
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Secondary outcome [12]
0
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US Specific: Percentage of Participants With Enhanced Clinical Response
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Assessment method [12]
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Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
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Timepoint [12]
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Week 12
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Secondary outcome [13]
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US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at
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Assessment method [13]
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Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
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Timepoint [13]
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Week 12
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Secondary outcome [14]
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US Specific: Percentage of Participants With CD-Related Hospitalization
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Assessment method [14]
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Participants with at least one admission to the hospital due to Crohn's Disease.
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Timepoint [14]
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Week 12
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Secondary outcome [15]
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US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
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Assessment method [15]
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Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
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Timepoint [15]
0
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Week 12
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Secondary outcome [16]
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Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
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Assessment method [16]
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The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
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Timepoint [16]
0
0
Week 12
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Secondary outcome [17]
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0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
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Assessment method [17]
0
0
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.
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Timepoint [17]
0
0
Week 4
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Secondary outcome [18]
0
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Global Outside of US: Percentage of Participants With Clinical Remission
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Assessment method [18]
0
0
Clinical remission is defined as using the average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline.
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Timepoint [18]
0
0
Week 4
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Secondary outcome [19]
0
0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
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Assessment method [19]
0
0
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.
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Timepoint [19]
0
0
Week 12
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Secondary outcome [20]
0
0
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
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Assessment method [20]
0
0
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
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Timepoint [20]
0
0
Week 12
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Secondary outcome [21]
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Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
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Assessment method [21]
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The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
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Timepoint [21]
0
0
Week 12
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Secondary outcome [22]
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Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
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Assessment method [22]
0
0
Enhanced clinical response was defined as = 60% decrease in average daily Stool Frequency and/or = 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
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Timepoint [22]
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0
Week 12
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Secondary outcome [23]
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Global Outside of US: Percentage of Participants With Endoscopic Remission
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Assessment method [23]
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Endoscopic remission: SES-CD = 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
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Timepoint [23]
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0
Week 12
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Secondary outcome [24]
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Global Outside of US: Percentage of Participants With Enhanced Clinical Response
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Assessment method [24]
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Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
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Timepoint [24]
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0
Week 4
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Secondary outcome [25]
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Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
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Assessment method [25]
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Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore = 1 at Baseline
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Timepoint [25]
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0
Week 12
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Secondary outcome [26]
0
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Global Outside of US: Percentage of Participants With Enhanced Clinical Response
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Assessment method [26]
0
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Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
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Timepoint [26]
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Week 12
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Secondary outcome [27]
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Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline
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Assessment method [27]
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Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
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Timepoint [27]
0
0
Week 12
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Secondary outcome [28]
0
0
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
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Assessment method [28]
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Participants with at least one admission to the hospital due to Crohn's Disease.
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Timepoint [28]
0
0
Week 12
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Secondary outcome [29]
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Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
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Assessment method [29]
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Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
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Timepoint [29]
0
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Week 12
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Secondary outcome [30]
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Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
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Assessment method [30]
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WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment \[OWI\]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
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Timepoint [30]
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Week 12
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Secondary outcome [31]
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Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
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Assessment method [31]
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The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
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Timepoint [31]
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Week 12
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Eligibility
Key inclusion criteria
* Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
* Diagnosis of CD for at least 3 months prior to Baseline.
* Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD.
* If female, participant must meet the contraception recommendations.
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Minimum age
16
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participants with unstable doses of concomitant Crohn's disease therapy.
* Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.
* Prior exposure to p19 inhibitors (e.g., risankizumab).
* Complications of Crohn's disease.
* Having an ostomy or ileoanal pouch.
* Known active Coronavirus Disease 2019 (COVID-19) infection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/04/2021
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Sample size
Target
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Accrual to date
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Final
931
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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0
Duplicate_Mater Hospital /ID# 167990 - South Brisbane
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Recruitment hospital [2]
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0
Griffith University /ID# 212627 - Southport
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Recruitment hospital [3]
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0
Lyell McEwin Hospital /ID# 211363 - Elizabeth Vale
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Recruitment hospital [4]
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0
Emeritus Research /ID# 213511 - Camberwell
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Recruitment hospital [5]
0
0
Footscray Hospital /ID# 211361 - Footscray
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Recruitment postcode(s) [1]
0
0
4101 - South Brisbane
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Recruitment postcode(s) [2]
0
0
4222 - Southport
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Recruitment postcode(s) [3]
0
0
5112 - Elizabeth Vale
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Recruitment postcode(s) [4]
0
0
3124 - Camberwell
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Recruitment postcode(s) [5]
0
0
3011 - Footscray
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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0
0
United States of America
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0
0
Arkansas
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0
0
United States of America
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0
0
California
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0
0
United States of America
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0
0
Colorado
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0
0
United States of America
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0
0
Connecticut
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0
0
United States of America
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0
0
Florida
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0
0
United States of America
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0
0
Georgia
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0
0
United States of America
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0
0
Illinois
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0
0
United States of America
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0
Kansas
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0
0
United States of America
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0
0
Kentucky
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0
0
United States of America
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State/province [11]
0
0
Louisiana
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Maryland
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Michigan
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0
0
United States of America
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State/province [14]
0
0
Minnesota
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0
0
United States of America
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State/province [15]
0
0
Mississippi
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Missouri
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0
0
United States of America
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State/province [17]
0
0
Nebraska
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Nevada
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Country [19]
0
0
United States of America
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State/province [19]
0
0
New York
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Country [20]
0
0
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North Carolina
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North Dakota
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0
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Ohio
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0
0
United States of America
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0
0
Oklahoma
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0
0
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0
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Oregon
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0
0
United States of America
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0
0
Pennsylvania
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0
0
United States of America
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0
0
South Carolina
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0
0
United States of America
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State/province [27]
0
0
South Dakota
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0
0
United States of America
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State/province [28]
0
0
Tennessee
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0
0
United States of America
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0
0
Texas
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0
0
United States of America
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0
0
Utah
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0
0
United States of America
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State/province [31]
0
0
Virginia
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0
0
United States of America
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State/province [32]
0
0
Washington
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Country [33]
0
0
United States of America
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State/province [33]
0
0
West Virginia
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Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Santa Fe
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Cordoba
Query!
Country [36]
0
0
Austria
Query!
State/province [36]
0
0
Niederoesterreich
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Steiermark
Query!
Country [38]
0
0
Austria
Query!
State/province [38]
0
0
Wien
Query!
Country [39]
0
0
Belarus
Query!
State/province [39]
0
0
Gomel
Query!
Country [40]
0
0
Belarus
Query!
State/province [40]
0
0
Grodno
Query!
Country [41]
0
0
Belarus
Query!
State/province [41]
0
0
???????
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Bruxelles-Capitale
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Namur
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Oost-Vlaanderen
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Vlaams-Brabant
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Bonheiden
Query!
Country [47]
0
0
Belgium
Query!
State/province [47]
0
0
Liege
Query!
Country [48]
0
0
Belgium
Query!
State/province [48]
0
0
Roeselare
Query!
Country [49]
0
0
Bosnia and Herzegovina
Query!
State/province [49]
0
0
Republika Srpska
Query!
Country [50]
0
0
Bosnia and Herzegovina
Query!
State/province [50]
0
0
Sarajevo
Query!
Country [51]
0
0
Brazil
Query!
State/province [51]
0
0
Goias
Query!
Country [52]
0
0
Brazil
Query!
State/province [52]
0
0
Parana
Query!
Country [53]
0
0
Brazil
Query!
State/province [53]
0
0
Rio Grande Do Sul
Query!
Country [54]
0
0
Brazil
Query!
State/province [54]
0
0
Sao Paulo
Query!
Country [55]
0
0
Bulgaria
Query!
State/province [55]
0
0
Pleven
Query!
Country [56]
0
0
Bulgaria
Query!
State/province [56]
0
0
Plovdiv
Query!
Country [57]
0
0
Bulgaria
Query!
State/province [57]
0
0
Sofia
Query!
Country [58]
0
0
Bulgaria
Query!
State/province [58]
0
0
Stara Zagora
Query!
Country [59]
0
0
Bulgaria
Query!
State/province [59]
0
0
Varna
Query!
Country [60]
0
0
Canada
Query!
State/province [60]
0
0
Alberta
Query!
Country [61]
0
0
Canada
Query!
State/province [61]
0
0
British Columbia
Query!
Country [62]
0
0
Canada
Query!
State/province [62]
0
0
Nova Scotia
Query!
Country [63]
0
0
Canada
Query!
State/province [63]
0
0
Ontario
Query!
Country [64]
0
0
Canada
Query!
State/province [64]
0
0
Quebec
Query!
Country [65]
0
0
Chile
Query!
State/province [65]
0
0
Region Metropolitana De Santiago
Query!
Country [66]
0
0
Chile
Query!
State/province [66]
0
0
Valparaíso
Query!
Country [67]
0
0
Chile
Query!
State/province [67]
0
0
Concepción
Query!
Country [68]
0
0
Chile
Query!
State/province [68]
0
0
Talcahuano
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
Guangdong
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Hebei
Query!
Country [71]
0
0
China
Query!
State/province [71]
0
0
Hubei
Query!
Country [72]
0
0
China
Query!
State/province [72]
0
0
Jiangxi
Query!
Country [73]
0
0
China
Query!
State/province [73]
0
0
Shanghai
Query!
Country [74]
0
0
China
Query!
State/province [74]
0
0
Zhejiang
Query!
Country [75]
0
0
China
Query!
State/province [75]
0
0
Changsha
Query!
Country [76]
0
0
China
Query!
State/province [76]
0
0
Chengdu
Query!
Country [77]
0
0
China
Query!
State/province [77]
0
0
Pudong New District
Query!
Country [78]
0
0
China
Query!
State/province [78]
0
0
Tianjin
Query!
Country [79]
0
0
Colombia
Query!
State/province [79]
0
0
Antioquia
Query!
Country [80]
0
0
Colombia
Query!
State/province [80]
0
0
Cundinamarca
Query!
Country [81]
0
0
Colombia
Query!
State/province [81]
0
0
Medellin
Query!
Country [82]
0
0
Croatia
Query!
State/province [82]
0
0
Grad Zagreb
Query!
Country [83]
0
0
Croatia
Query!
State/province [83]
0
0
Osjecko-baranjska Zupanija
Query!
Country [84]
0
0
Croatia
Query!
State/province [84]
0
0
Splitsko-dalmatinska Zupanija
Query!
Country [85]
0
0
Czechia
Query!
State/province [85]
0
0
Praha 4
Query!
Country [86]
0
0
Czechia
Query!
State/province [86]
0
0
Hradec Kralove
Query!
Country [87]
0
0
Czechia
Query!
State/province [87]
0
0
Olomouc
Query!
Country [88]
0
0
Czechia
Query!
State/province [88]
0
0
Pardubice
Query!
Country [89]
0
0
Czechia
Query!
State/province [89]
0
0
Praha
Query!
Country [90]
0
0
Estonia
Query!
State/province [90]
0
0
Harjumaa
Query!
Country [91]
0
0
Estonia
Query!
State/province [91]
0
0
Tallinn
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Baden-Wuerttemberg
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Bayern
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Hessen
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Nordrhein-Westfalen
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Saarland
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Schleswig-Holstein
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Thueringen
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Berlin-Zehlendorf
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Berlin
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Braunschweig
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Dachau
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Frankfurt am Main
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Hamburg
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Hannover
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Leipzig
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Lueneburg
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Magdeburg
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Minden
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Regensburg
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Wiesbaden
Query!
Country [112]
0
0
Greece
Query!
State/province [112]
0
0
Attiki
Query!
Country [113]
0
0
Greece
Query!
State/province [113]
0
0
Kriti
Query!
Country [114]
0
0
Greece
Query!
State/province [114]
0
0
Athens
Query!
Country [115]
0
0
Greece
Query!
State/province [115]
0
0
Ioannina
Query!
Country [116]
0
0
Greece
Query!
State/province [116]
0
0
Pireaus
Query!
Country [117]
0
0
Greece
Query!
State/province [117]
0
0
Thessaloniki
Query!
Country [118]
0
0
Hong Kong
Query!
State/province [118]
0
0
Hong Kong
Query!
Country [119]
0
0
Hong Kong
Query!
State/province [119]
0
0
Tuen Mun
Query!
Country [120]
0
0
Ireland
Query!
State/province [120]
0
0
Dublin
Query!
Country [121]
0
0
Ireland
Query!
State/province [121]
0
0
Galway
Query!
Country [122]
0
0
Israel
Query!
State/province [122]
0
0
HaDarom
Query!
Country [123]
0
0
Israel
Query!
State/province [123]
0
0
Tel-Aviv
Query!
Country [124]
0
0
Israel
Query!
State/province [124]
0
0
Haifa
Query!
Country [125]
0
0
Israel
Query!
State/province [125]
0
0
Holon
Query!
Country [126]
0
0
Israel
Query!
State/province [126]
0
0
Jerusalem
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Ancona
Query!
Country [128]
0
0
Italy
Query!
State/province [128]
0
0
Calabria
Query!
Country [129]
0
0
Italy
Query!
State/province [129]
0
0
Emilia-Romagna
Query!
Country [130]
0
0
Italy
Query!
State/province [130]
0
0
Lazio
Query!
Country [131]
0
0
Italy
Query!
State/province [131]
0
0
Milano
Query!
Country [132]
0
0
Italy
Query!
State/province [132]
0
0
Roma
Query!
Country [133]
0
0
Italy
Query!
State/province [133]
0
0
Toscana
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Verona
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Bologna
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Catania
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Genova
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Milan
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Palermo
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Pavia
Query!
Country [141]
0
0
Japan
Query!
State/province [141]
0
0
Aichi
Query!
Country [142]
0
0
Japan
Query!
State/province [142]
0
0
Chiba
Query!
Country [143]
0
0
Japan
Query!
State/province [143]
0
0
Fukuoka
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Hiroshima
Query!
Country [145]
0
0
Japan
Query!
State/province [145]
0
0
Hokkaido
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Hyogo
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Ibaraki
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Ishikawa
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Kanagawa
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Mie
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Miyagi
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Osaka
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Saitama
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Shiga
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Shizuoka
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Tokyo
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Wakayama
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Yamagata
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Yamanashi
Query!
Country [160]
0
0
Korea, Republic of
Query!
State/province [160]
0
0
Gyeonggido
Query!
Country [161]
0
0
Korea, Republic of
Query!
State/province [161]
0
0
Seoul Teugbyeolsi
Query!
Country [162]
0
0
Korea, Republic of
Query!
State/province [162]
0
0
Busan
Query!
Country [163]
0
0
Korea, Republic of
Query!
State/province [163]
0
0
Daegu
Query!
Country [164]
0
0
Korea, Republic of
Query!
State/province [164]
0
0
Daejeon
Query!
Country [165]
0
0
Korea, Republic of
Query!
State/province [165]
0
0
Seoul
Query!
Country [166]
0
0
Latvia
Query!
State/province [166]
0
0
Riga
Query!
Country [167]
0
0
Lithuania
Query!
State/province [167]
0
0
Kaunas
Query!
Country [168]
0
0
Lithuania
Query!
State/province [168]
0
0
Vilnius
Query!
Country [169]
0
0
Malaysia
Query!
State/province [169]
0
0
Sabah
Query!
Country [170]
0
0
Malaysia
Query!
State/province [170]
0
0
Selangor
Query!
Country [171]
0
0
Malaysia
Query!
State/province [171]
0
0
Kelantan
Query!
Country [172]
0
0
Mexico
Query!
State/province [172]
0
0
Jalisco
Query!
Country [173]
0
0
Mexico
Query!
State/province [173]
0
0
Morelos
Query!
Country [174]
0
0
Mexico
Query!
State/province [174]
0
0
Yucatan
Query!
Country [175]
0
0
Mexico
Query!
State/province [175]
0
0
Del. Benito Juárez
Query!
Country [176]
0
0
Netherlands
Query!
State/province [176]
0
0
Amsterdam
Query!
Country [177]
0
0
Netherlands
Query!
State/province [177]
0
0
Tilburg
Query!
Country [178]
0
0
New Zealand
Query!
State/province [178]
0
0
Canterbury
Query!
Country [179]
0
0
New Zealand
Query!
State/province [179]
0
0
Otago
Query!
Country [180]
0
0
New Zealand
Query!
State/province [180]
0
0
Wellington
Query!
Country [181]
0
0
Norway
Query!
State/province [181]
0
0
Akershus
Query!
Country [182]
0
0
Norway
Query!
State/province [182]
0
0
Gjettum
Query!
Country [183]
0
0
Norway
Query!
State/province [183]
0
0
Levanger
Query!
Country [184]
0
0
Norway
Query!
State/province [184]
0
0
Ålesund
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Dolnoslaskie
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Kujawsko-pomorskie
Query!
Country [187]
0
0
Poland
Query!
State/province [187]
0
0
Lodzkie
Query!
Country [188]
0
0
Poland
Query!
State/province [188]
0
0
Lubelskie
Query!
Country [189]
0
0
Poland
Query!
State/province [189]
0
0
Mazowieckie
Query!
Country [190]
0
0
Poland
Query!
State/province [190]
0
0
Podkarpackie
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Pomorskie
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Slaskie
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Warminsko-mazurskie
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Poznan
Query!
Country [195]
0
0
Poland
Query!
State/province [195]
0
0
Warsaw
Query!
Country [196]
0
0
Poland
Query!
State/province [196]
0
0
Wroclaw
Query!
Country [197]
0
0
Portugal
Query!
State/province [197]
0
0
Braga
Query!
Country [198]
0
0
Portugal
Query!
State/province [198]
0
0
Faro
Query!
Country [199]
0
0
Portugal
Query!
State/province [199]
0
0
Porto
Query!
Country [200]
0
0
Portugal
Query!
State/province [200]
0
0
Almada
Query!
Country [201]
0
0
Portugal
Query!
State/province [201]
0
0
Lisboa
Query!
Country [202]
0
0
Portugal
Query!
State/province [202]
0
0
Loures
Query!
Country [203]
0
0
Portugal
Query!
State/province [203]
0
0
Viseu
Query!
Country [204]
0
0
Romania
Query!
State/province [204]
0
0
Bucuresti
Query!
Country [205]
0
0
Romania
Query!
State/province [205]
0
0
Cluj
Query!
Country [206]
0
0
Romania
Query!
State/province [206]
0
0
Timisoara
Query!
Country [207]
0
0
Romania
Query!
State/province [207]
0
0
Timi?oara
Query!
Country [208]
0
0
Russian Federation
Query!
State/province [208]
0
0
Kemerovskaya Oblast
Query!
Country [209]
0
0
Russian Federation
Query!
State/province [209]
0
0
Permskiy Kray
Query!
Country [210]
0
0
Russian Federation
Query!
State/province [210]
0
0
Sankt-Peterburg
Query!
Country [211]
0
0
Russian Federation
Query!
State/province [211]
0
0
Stavropol Skiy Kray
Query!
Country [212]
0
0
Russian Federation
Query!
State/province [212]
0
0
Tverskaya Oblast
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Tyumenskaya Oblast
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
Udmurtskaya Respublika
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Moscow
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Novosibirsk
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
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Russian Federation
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????
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Devon
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United Kingdom
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Leeds
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London
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Oxford
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Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Ethics approval
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03105128
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Trial related presentations / publications
D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/28/NCT03105128/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/28/NCT03105128/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03105128