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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02365649
Registration number
NCT02365649
Ethics application status
Date submitted
16/02/2015
Date registered
19/02/2015
Date last updated
14/08/2023
Titles & IDs
Public title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Upadacitinib (ABT-494) for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
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Secondary ID [1]
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2014-003240-12
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Secondary ID [2]
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M13-740
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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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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - ABT-494
Active Comparator: Induction Period ABT-494 Twice Daily Medium/High Dose - Induction Period ABT-494 Twice Daily Medium/High Dose orally dosed twice a day
Active Comparator: Extension Phase ABT-494 High Dose - Extension Phase ABT-494 High Dose orally dosed twice a day
Placebo Comparator: Induction Period Placebo - Induction Period Placebo orally dosed twice a day
Active Comparator: Induction Period ABT-494 Low Dose - Induction Period ABT-494 Low Dose orally dosed twice a day
Active Comparator: Induction Period ABT-494 Once Daily Medium/High Dose - Induction Period ABT-494 Once Daily Medium/High Dose orally dosed once a day
Active Comparator: Extension Phase ABT-494 Low Dose - Extension Phase ABT-494 Low Dose orally dosed twice a day
Active Comparator: Induction Period ABT-494 High Dose - Induction Period ABT-494 High Dose orally dosed twice a day
Active Comparator: Induction Period ABT-494 Low/Medium Dose - Induction Period ABT-494 Low/Medium Dose orally dosed twice a day
Active Comparator: Extension Phase ABT-494 Medium Dose - Extension Phase ABT-494 Medium Dose orally dosed twice a day
Treatment: Drugs: Placebo
Oral Dosing
Treatment: Drugs: ABT-494
Oral Dosing
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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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Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16
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Assessment method [1]
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Endoscopic remission was determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. Endoscopic remission: SES-CD = 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable.
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Timepoint [1]
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Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
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Primary outcome [2]
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Percentage of Participants Who Achieve Clinical Remission at Week 16
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Assessment method [2]
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Clinical remission: average daily stool frequency = 1.5 and not worse than Baseline AND average daily abdominal pain = 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
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Timepoint [2]
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Week 16
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Secondary outcome [1]
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Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16
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Assessment method [1]
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CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Percentage of Participants With a Decrease in CDAI = 70 Points From Baseline at Week 16
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Assessment method [2]
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CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A 70-point decrease in the CDAI index refers to improvement in the disease activity from Baseline.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Percentage of Participants Who Achieve Clinical Remission at Week 12
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Assessment method [3]
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Clinical remission: average daily stool frequency = 1.5 and not worse than Baseline AND average daily abdominal pain = 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants Who Achieve Remission at Week 16
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Assessment method [4]
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Remission is defined as endoscopic remission at Week 12/16 AND clinical remission at Week 16. Endoscopic remission: SES-CD = 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Clinical remission: average daily stool frequency = 1.5 and not worse than Baseline AND average daily abdominal pain = 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Percentage of Participants Who Achieve Response at Week 16
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Assessment method [5]
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Response is defined as endoscopic response at Week 12/16 AND clinical response at Week 16. Endoscopic response: SES-CD at least 25% reduction from Baseline. Clinical response: average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain not worse than Baseline OR average daily abdominal pain at least 30% reduction from Baseline and average daily stool frequency not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
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Timepoint [5]
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Week 16
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Secondary outcome [6]
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Percentage of Participants With Endoscopic Response at Week 12/16
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Assessment method [6]
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Endoscopic response: SES-CD at least 25% reduction from Baseline. Details of the SES-CD scale are provided in the description of the first primary endpoint.
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Timepoint [6]
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Up to Week 16 (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
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Secondary outcome [7]
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Percentage of Participants Who Achieve Clinical Response at Week 16
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Assessment method [7]
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Clinical response: average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain not worse than Baseline OR average daily abdominal pain at least 30% reduction from Baseline and average daily stool frequency not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
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Timepoint [7]
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Week 16
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Secondary outcome [8]
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Percentage of Participants With an Average Daily Stool Frequency = 2.5 AND Average Daily Abdominal Pain = 2.0 at Baseline Who Achieve Clinical Remission at Week 16
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Assessment method [8]
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Clinical remission: average daily stool frequency = 1.5 and not worse than Baseline AND average daily abdominal pain = 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
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Timepoint [8]
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Week 16
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Secondary outcome [9]
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Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16
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Assessment method [9]
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CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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Perentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16
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Assessment method [10]
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Remission is defined as endoscopic remission at Week 12/16 AND clinical remission at Week 16. Endoscopic remission: SES-CD = 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Clinical remission: average daily stool frequency = 1.5 and not worse than Baseline AND average daily abdominal pain = 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
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Timepoint [10]
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0
Up to Week 16. (At Baseline, subjects were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
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Secondary outcome [11]
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Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16
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Assessment method [11]
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Clinical remission: average daily stool frequency = 1.5 and not worse than Baseline AND average daily abdominal pain = 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
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Timepoint [11]
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Week 16
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Secondary outcome [12]
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Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16
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Assessment method [12]
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Endoscopic remission: SES-CD = 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
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Timepoint [12]
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0
Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
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Secondary outcome [13]
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Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase
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Assessment method [13]
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0
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Timepoint [13]
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Baseline, Week 4, Week 16
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Secondary outcome [14]
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Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16
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Assessment method [14]
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0
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Timepoint [14]
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0
Baseline, Week 16
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Secondary outcome [15]
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase
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Assessment method [15]
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The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The total score ranges from 32 to 224 using the 7-point response options, with higher scores indicating better health-related quality of life.
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Timepoint [15]
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Baseline, Week 8, Week 16
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Secondary outcome [16]
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Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16
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Assessment method [16]
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Remission is defined as endoscopic remission AND clinical remission. Endoscopic remission: SES-CD = 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Clinical remission: average daily stool frequency = 1.5 and not worse than Baseline AND average daily abdominal pain = 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
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Timepoint [16]
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0
Week 16
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Secondary outcome [17]
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Percentage of Participants With a Decrease in CDAI = 100 Points From Baseline at Week 16
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Assessment method [17]
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0
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission and a score above 450 indicates very severe disease.
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Timepoint [17]
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0
Week 16
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Secondary outcome [18]
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Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16
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Assessment method [18]
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Endoscopic remission: SES-CD = 4 and at least two point reduction versus Baseline and no subscore > 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
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Timepoint [18]
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0
Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
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Secondary outcome [19]
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Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency = 4.0 or Average Daily Abdominal Pain = 2.0 at Baseline
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Assessment method [19]
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Modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than Baseline and average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
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Timepoint [19]
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Week 16
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Secondary outcome [20]
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Change From Baseline in Abdominal Pain Rating Scale at Week 12
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Assessment method [20]
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Abdominal pain was assessed on an abdominal pain rating scale, where subjects rated their average abdominal pain over the last 24 hours on a scale of 0 (none) to 10 (worst pain imaginable).
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Timepoint [20]
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Baseline, Week 12
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Secondary outcome [21]
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Change From Baseline in Abdominal Pain Rating Scale at Week 16
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Assessment method [21]
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Abdominal pain was assessed on an abdominal pain rating scale, where subjects rated their average abdominal pain over the last 24 hours on a scale of 0 (none) to 10 (worst pain imaginable).
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Timepoint [21]
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Baseline, Week 16
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Secondary outcome [22]
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Percentage of Participants Who Achieve Remission at Week 52
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Assessment method [22]
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Remission at Week 52 was defined as both endoscopic remission at Week 52 and clinical remission at Week 52. Endoscopic remission: SES-CD = 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Clinical remission: average daily stool frequency = 1.5 and not worse than Baseline AND average daily abdominal pain = 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record. See definitions of responder and clinical responder in Outcome Measure 7 of this record.
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Timepoint [22]
0
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Week 52
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Secondary outcome [23]
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0
Percentage of Participants Who Achieve Endoscopic Remission at Week 52
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Assessment method [23]
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Endoscopic remission: SES-CD = 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint. Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
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Timepoint [23]
0
0
Week 52
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Secondary outcome [24]
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Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency = 4.0 or Daily Abdominal Pain = 2.0 at Induction Baseline
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Assessment method [24]
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Endoscopic remission was defined as SES-CD <= 4 and at least 2 points reduction versus induction baseline and no subscore > 1 in any individual variable. Modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than induction baseline AND average daily abdominal pain <= 1.0 and not worse than induction baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record.
Subjects from ITT population with daily stool frequency >= 4.0 or daily abdominal pain >= 2.0 at Induction Baseline. Non responder imputation. n=total subjects, by Week 16 status (responder/nonresponder).
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Timepoint [24]
0
0
Week 52
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Secondary outcome [25]
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0
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase
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Assessment method [25]
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0
Clinical remission was defined as average daily stool frequency <= 1.5 and not worse than Induction Baseline and average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
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Timepoint [25]
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0
Week 20, Week 28, Week 36, Week 44, Week 52
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Secondary outcome [26]
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Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16
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Assessment method [26]
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0
Clinical remission was defined as average daily stool frequency <= 1.5 and not worse than Induction Baseline and average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Subjects from ITT population in clinical remission at Week 16. Non responder imputation. n=total subjects, by Week 16 status (responder/nonresponder).
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Timepoint [26]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
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Secondary outcome [27]
0
0
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency = 4.0 or Daily Abdominal Pain = 2.0 at Induction Baseline
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Assessment method [27]
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0
Modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than Induction Baseline and average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Subjects from ITT population with daily stool frequency >= 4.0 or daily abdominal pain >= 2.0 at Induction Baseline. Non responder imputation. n=total subjects, by Week 16 status (responder/nonresponder).
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Timepoint [27]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
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Secondary outcome [28]
0
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Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency = 4.0 or Daily Abdominal Pain = 2.0 at Induction Baseline
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Assessment method [28]
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0
Modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than Induction Baseline and average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Subjects from ITT population with modified clinical remission at Week 16 and daily stool frequency >= 4.0 or daily abdominal pain >= 2.0 at Induction Baseline. Non responder imputation. n=total subjects, by Week 16 status (responder/nonresponder).
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Timepoint [28]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
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Secondary outcome [29]
0
0
Percentage of Participants Who Achieve Response at Week 52
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Assessment method [29]
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0
Response at Week 52 was defined as both endoscopic response at Week 52 and clinical response at
Week 52. Endoscopic response: SES-CD at least 25% reduction from Baseline. Clinical response:
average daily stool frequency at least 30% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 30% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline.
The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint. Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
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Timepoint [29]
0
0
Week 52
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Secondary outcome [30]
0
0
Percentage of Participants With SES-CD = 2 at Week 52
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Assessment method [30]
0
0
See SES-CD description details in the first primary endpoint description of this record.
Non responder imputation. n=total participants, by Week 16 status (responder/non-responder).
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Timepoint [30]
0
0
Week 52
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Secondary outcome [31]
0
0
Percentage of Participants With SES-CD = 0 at Week 52
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Assessment method [31]
0
0
See SES-CD description details in the first primary endpoint description of this record.
Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
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Timepoint [31]
0
0
Week 52
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Secondary outcome [32]
0
0
Percentage of Participants Who Achieve Endoscopic Response at Week 52
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Assessment method [32]
0
0
Endoscopic response was defined as SES-CD at least 25% reduction from Induction Baseline. Details of the SES-CD scale are provided in the description of the first primary endpoint. Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
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Timepoint [32]
0
0
Week 52
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Secondary outcome [33]
0
0
Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52
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Assessment method [33]
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0
Enhanced endoscopic response was defined as SES-CD reduction from Induction Baseline > 50% (or for an Induction Baseline SES-CD of 4, at least a 2 point reduction from Induction Baseline). Details of the SES-CD scale are provided in the description of the first primary endpoint. Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
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Timepoint [33]
0
0
Week 52
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Secondary outcome [34]
0
0
Percentage of Participants Who Achieve Endoscopic Improvement at Week 52
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Assessment method [34]
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Endoscopic Improvement: SES-CD reduction from Induction Baseline > 50% or endoscopic remission.
Endoscopic remission was defined as SES-CD <= 4 and at least 2 points reduction versus Induction Baseline and no subscore > 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint. Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
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Timepoint [34]
0
0
Week 52
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Secondary outcome [35]
0
0
Percentage of Participants Who Achieve Endoscopic Healing at Week 52
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Assessment method [35]
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0
Endoscopic healing was defined as SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore >= 1 at Induction Baseline. Details of the SES-CD scale are provided in the description of the first primary endpoint. Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
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Timepoint [35]
0
0
Week 52
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Secondary outcome [36]
0
0
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
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Assessment method [36]
0
0
Clinical response was defined as average daily stool frequency at least 30% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 30% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
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Timepoint [36]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
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Secondary outcome [37]
0
0
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
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Assessment method [37]
0
0
Enhanced clinical response was defined as average daily stool frequency at least 60% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 35% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline or modified clinical remission (average daily stool frequency = 2.8 and not worse than Induction baseline AND average daily abdominal pain = 1.0 and not worse than Induction baseline). The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit.
Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
Query!
Timepoint [37]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
Query!
Secondary outcome [38]
0
0
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Query!
Assessment method [38]
0
0
Enhanced clinical response was defined as average daily stool frequency at least 60% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline or average daily abdominal pain at least 35% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline or modified clinical remission (average daily stool frequency = 2.8 and not worse than Induction baseline AND average daily abdominal pain = 1.0 and not worse than Induction baseline). The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit.
Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Subjects from ITT population with enhanced clinical response at Week 16. Non responder imputation.
n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [38]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
Query!
Secondary outcome [39]
0
0
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency = 2.5 and Average Daily Abdominal Pain = 2.0 at Induction Baseline
Query!
Assessment method [39]
0
0
Clinical remission was defined as average daily stool frequency <= 1.5 and not worse than Induction Baseline AND average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Subjects from ITT population with man average daily stool frequency >= 2.5 and average daily abdominal pain >= 2.0 at Induction Baseline. Non responder imputation. n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [39]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
Query!
Secondary outcome [40]
0
0
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Query!
Assessment method [40]
0
0
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Subjects from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [40]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
Query!
Secondary outcome [41]
0
0
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52
Query!
Assessment method [41]
0
0
Steroid-free remission at Week 52 was defined as both endoscopic remission at Week 52 and clinical remission at Week 52. Endoscopic remission: SES-CD = 4 and at least 2 point reduction versus Induction Baseline and no subscore > 1 in any individual variable. Clinical remission: Average daily stool frequency = 1.5 and not worse than baseline AND average daily abdominal pain = 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record. Subjects from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
n=total subjects, by Week 16 status (responder/non-responder).
Query!
Timepoint [41]
0
0
Week 52
Query!
Secondary outcome [42]
0
0
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Query!
Assessment method [42]
0
0
Steroid-free clinical remission was defined as average daily stool frequency <= 1.5 and not worse than Induction Baseline AND average daily abdominal pain <= 1.0 and not worse than Induction Baseline.
The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Subjects from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [42]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
Query!
Secondary outcome [43]
0
0
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency = 4.0 or Daily Abdominal Pain = 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Query!
Assessment method [43]
0
0
Steroid-free modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than Induction Baseline AND average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Subjects from ITT population taking corticosteroids at Induction Baseline and Daily Stool Frequency >= 4.0 OR Daily Abdominal Pain >= 2.0 at Induction Baseline. Non responder imputation. n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [43]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
Query!
Secondary outcome [44]
0
0
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52
Query!
Assessment method [44]
0
0
Steroid-free endoscopic remission was defined as SES-CD <= 4 and at least 2 points reduction versus Induction Baseline and no subscore > 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint. Subjects from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [44]
0
0
Week 52
Query!
Secondary outcome [45]
0
0
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Query!
Assessment method [45]
0
0
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
Query!
Timepoint [45]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
Query!
Secondary outcome [46]
0
0
Percentage of Participants With Decrease in CDAI = 70 Points From Induction Baseline Over Time During Extension Phase
Query!
Assessment method [46]
0
0
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A 70-point decrease in the CDAI index refers to improvement in the disease activity from Baseline. Non responder imputation. n=total subjects, by Week 16 status (responder/non-responder).
Query!
Timepoint [46]
0
0
Week 20, Week 28, Week 36, Week 44, Week 52
Query!
Secondary outcome [47]
0
0
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Query!
Assessment method [47]
0
0
Participants from ITT population with an assessment at given time point. Last observation carried forward.
n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [47]
0
0
Baseline, Week 28, Week 52
Query!
Secondary outcome [48]
0
0
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Query!
Assessment method [48]
0
0
Subjects from ITT population with an assessment at given time point. Last observation carried forward.
n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [48]
0
0
Baseline, Week 20, Week 28, Week 36, Week 44, Week 52
Query!
Secondary outcome [49]
0
0
Change From Induction Baseline in IBDQ at Week 52
Query!
Assessment method [49]
0
0
The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The total score ranges from 32 to 224 using the 7-point response options, with higher scores indicating better health-related quality of life. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function, and social function. Each subscale can be computed with total scores ranging from 10 to 70, 5 to 35, 12 to 84, and 5 to 35, respectively. Subjects from ITT population with an assessment at given time point. Observed cases. n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [49]
0
0
Baseline, Week 52
Query!
Secondary outcome [50]
0
0
Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52
Query!
Assessment method [50]
0
0
The EQ-5D is a standardized instrument for use as a measure of health-related quality of life. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. A positive change represents an improvement in health-related quality of life. Subjects from ITT population with an assessment at given time point. Observed cases. n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [50]
0
0
Baseline, Week 52
Query!
Secondary outcome [51]
0
0
Change From Induction Baseline in EQ-5D VAS at Week 52
Query!
Assessment method [51]
0
0
The EQ-5D is a standardized instrument for use as a measure of health-related quality of life. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in health-related quality of life. Subjects from ITT population with an assessment at given time point. Observed cases. n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [51]
0
0
Baseline, Week 52
Query!
Secondary outcome [52]
0
0
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
Query!
Assessment method [52]
0
0
Presented as percentage of subjects with given number of EIMs at Baseline and Week (Wk) 52. EIMs of Crohn's disease included anemia, autoimmune hepatitis, axial arthropathy, bronchiectasis, chronic obstructive pulmonary disease, episcleritis, erythema nodosum, iritis, nephrolithiasis, oral aphthous ulcers, peripheral arthropathy, primary sclerosing cholangitis, pyoderma gangrenosum, Sweet's syndrome, uveitis, and venous thromboembolism. Subjects from modified ITT population (all randomized subjects who took at least 1 dose of study drug in the Induction Period). n=total subjects, by number of EIMs at Induction Baseline (BL).
Query!
Timepoint [52]
0
0
Baseline, Week 52
Query!
Secondary outcome [53]
0
0
Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline
Query!
Assessment method [53]
0
0
Remission at Week 52 is defined as endoscopic remission at Week 52 AND clinical remission at Week 52.
Endoscopic remission: SES-CD = 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Clinical remission: average daily stool frequency = 1.5 and not worse than Baseline AND average daily abdominal pain = 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint. Subjects from ITT population with isolated ileal Crohn's disease at Induction Baseline. Non responder imputation. n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [53]
0
0
Week 52
Query!
Secondary outcome [54]
0
0
Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency = 4.0 or Daily Abdominal Pain = 2.0 at Induction Baseline
Query!
Assessment method [54]
0
0
Modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than induction baseline AND average daily abdominal pain <= 1.0 and not worse than induction baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Subjects from ITT population with isolated ileal Crohn's disease at Induction Baseline and daily stool frequency >= 4.0 or daily abdominal pain >=2.0 at Induction Baseline. Non responder imputation.
n=total subjects, by Week 16 status (responder/nonresponder).
Query!
Timepoint [54]
0
0
Week 52
Query!
Eligibility
Key inclusion criteria
1. Diagnosis of Crohn's disease (CD) for at least 90 days.
2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or
equal to 450.
3. Subject inadequately responded to or experienced intolerance to previous treatment
with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or
anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).
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Minimum age
18
Years
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Query!
Maximum age
75
Years
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Query!
Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.
2. Subject who has had surgical bowel resections in the past 6 months or is planning
resection.
3. Subjects with an ostomy or ileoanal pouch.
4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
5. Subject who has short bowel syndrome.
6. Subject with recurring infections or active Tuberculosis (TB).
Query!
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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
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Date of first participant enrolment
Anticipated
Query!
Actual
17/03/2015
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Date of last participant enrolment
Anticipated
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Actual
Query!
Date of last data collection
Anticipated
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Actual
3/08/2017
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Sample size
Target
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Accrual to date
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Final
220
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Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
Query!
Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately
to severely active Crohn's Disease with a history of inadequate response to or intolerance to
Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02365649
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
0
0
AbbVie Inc.
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Address
0
0
AbbVie
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02365649
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