A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease - Full Text View - ClinicalTrials.gov (2022)

  • US Specific: Percentage of Participants With Clinical Remission [TimeFrame:Week 12]

    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.


  • US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [TimeFrame:Week 4]

    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.


  • US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [TimeFrame:Week 12]

    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.


  • US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [TimeFrame:Week 12]

    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.


  • US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [TimeFrame:Week 4]

    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.


  • US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response [TimeFrame:Week 12]

    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).


  • US Specific: Percentage of Participants With Stool Frequency (SF) Remission [TimeFrame:Week 12]

    Stool Frequency (SF) remission is defined as an average daily SF <= 2.8 and not worse than baseline.


  • US Specific: Percentage of Participants With Abdominal Pain (AP) Remission [TimeFrame:Week 12]

    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.


  • US Specific: Percentage of Participants With Endoscopic Remission [TimeFrame:Week 12]

    Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable


  • US Specific: Percentage of Participants With Enhanced Clinical Response [TimeFrame:Week 4]

    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


  • US Specific: Percentage of Participants With Ulcer-Free Endoscopy [TimeFrame:Week 12]

    Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline


  • US Specific: Percentage of Participants With Enhanced Clinical Response [TimeFrame:Week 12]

    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


  • US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at [TimeFrame:Week 12]

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


  • US Specific: Percentage of Participants With CD-Related Hospitalization [TimeFrame:Week 12]

    Participants with at least one admission to the hospital due to Crohn's Disease.


  • US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline [TimeFrame:Week 12]

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


  • Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [TimeFrame:Week 12]

    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.


  • Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [TimeFrame:Week 4]

    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.


  • Global Outside of US: Percentage of Participants With Clinical Remission [TimeFrame:Week 4]

    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.


  • Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [TimeFrame:Week 12]

    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.


  • Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [TimeFrame:Week 12]

    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.


  • Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score [TimeFrame:Week 12]

    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.


  • Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response [TimeFrame:Week 12]

    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).


  • Global Outside of US: Percentage of Participants With Endoscopic Remission [TimeFrame:Week 12]

    Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable


  • Global Outside of US: Percentage of Participants With Enhanced Clinical Response [TimeFrame:Week 4]

    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


  • Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy [TimeFrame:Week 12]

    Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline


  • Global Outside of US: Percentage of Participants With Enhanced Clinical Response [TimeFrame:Week 12]

    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


  • Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline [TimeFrame:Week 12]

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


  • Global Outside of US: Percentage of Participants With CD-Related Hospitalization [TimeFrame:Week 12]

    Participants with at least one admission to the hospital due to Crohn's Disease.


  • Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline [TimeFrame:Week 12]

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


  • Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment [TimeFrame:Week 12]

    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.


  • Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score [TimeFrame:Week 12]

    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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