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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02819635
Registration number
NCT02819635
Ethics application status
Date submitted
28/06/2016
Date registered
30/06/2016
Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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0
2016-000641-31
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Secondary ID [2]
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0
M14-234
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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:
Ulcerative Colitis (UC)
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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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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Upadacitinib
Placebo comparator: SS1: Placebo - During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Experimental: SS1: Upadacitinib 7.5 mg - During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Experimental: SS1: Upadacitinib 15 mg - During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Experimental: SS1: Upadacitinib 30 mg - During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Experimental: SS1: Upadacitinib 45 mg - During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Experimental: SS2: Placebo/Upadacitinib 45 mg - During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
Experimental: SS2: Upadacitinib 45 mg/Upadacitinib 45 mg - During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
Experimental: SS3: M14-675 clinical responders - Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were re-randomized and treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth \[QD\], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
Treatment: Drugs: Placebo
Film-coated tablet for oral administration
Treatment: Drugs: Upadacitinib
Film-coated tablet for oral administration
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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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Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
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Assessment method [1]
0
0
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 1, clinical remission is defined as SFS = 1, RBS of 0, and endoscopic subscore = 1.
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Timepoint [1]
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0
At Week 8
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Primary outcome [2]
0
0
Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
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Assessment method [2]
0
0
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)
3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 2, clinical remission is defined as SFS = 1 and not greater than Baseline, RBS of 0, and endoscopic subscore = 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
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Timepoint [2]
0
0
At Week 8
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Primary outcome [3]
0
0
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52
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Assessment method [3]
0
0
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 3, clinical remission is defined as SFS = 1 and not greater than Baseline, RBS of 0, and endoscopic subscore = 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
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Timepoint [3]
0
0
At Week 52
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Secondary outcome [1]
0
0
Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8
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Assessment method [1]
0
0
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
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Timepoint [1]
0
0
At Week 8
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Secondary outcome [2]
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Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8
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Assessment method [2]
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0
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score = 2 and no individual subscore \> 1.
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Timepoint [2]
0
0
At Week 8
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Secondary outcome [3]
0
0
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
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Assessment method [3]
0
0
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score = 2 points and = 30% from baseline, and a decrease in RBS = 1 or an absolute RBS = 1).
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Timepoint [3]
0
0
At Week 8
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Secondary outcome [4]
0
0
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
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Assessment method [4]
0
0
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score = 2 points and = 30% from Baseline, plus a decrease in RBS = 1 or an absolute RBS = 1.
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Timepoint [4]
0
0
At Week 2
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Secondary outcome [5]
0
0
Substudy 1: Change in Full Mayo Score From Baseline to Week 8
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Assessment method [5]
0
0
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score = 2 and no individual subscore \> 1.
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Timepoint [5]
0
0
Baseline (Week 0), Week 8
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Secondary outcome [6]
0
0
Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8
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Assessment method [6]
0
0
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
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Timepoint [6]
0
0
At Week 8
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Secondary outcome [7]
0
0
Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
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Assessment method [7]
0
0
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Histologic improvement was defined as decrease from baseline in Geboes score.
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Timepoint [7]
0
0
At Week 8
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Secondary outcome [8]
0
0
Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8
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Assessment method [8]
0
0
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
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Timepoint [8]
0
0
At Week 8
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Secondary outcome [9]
0
0
Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8
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Assessment method [9]
0
0
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
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Timepoint [9]
0
0
At Week 8
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Secondary outcome [10]
0
0
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
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Assessment method [10]
0
0
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score = 2 points and = 30% from baseline, and a decrease in RBS = 1 or an absolute RBS = 1).
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Timepoint [10]
0
0
At Week 8
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Secondary outcome [11]
0
0
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
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Assessment method [11]
0
0
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical response per Partial Mayo Score is defined as a decrease from Baseline = 1 point and = 30% from Baseline, plus a decrease in RBS = 1 or an absolute RBS = 1.
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Timepoint [11]
0
0
At Week 2
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Secondary outcome [12]
0
0
Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
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Assessment method [12]
0
0
Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score = 3.1.
The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
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Timepoint [12]
0
0
At Week 8
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Secondary outcome [13]
0
0
Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8
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Assessment method [13]
0
0
Bowel urgency was assessed by participants in a subject diary completed once a day.
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Timepoint [13]
0
0
At Week 8
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Secondary outcome [14]
0
0
Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8
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Assessment method [14]
0
0
Abdominal pain was assessed by participants in a subject diary completed once a day.
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Timepoint [14]
0
0
At Week 8
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Secondary outcome [15]
0
0
Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
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Assessment method [15]
0
0
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. Histologic improvement was defined as decrease from baseline in Geboes score.
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Timepoint [15]
0
0
At Week 8
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Secondary outcome [16]
0
0
Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8
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Assessment method [16]
0
0
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
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Timepoint [16]
0
0
Baseline (Week 0), Week 8
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Secondary outcome [17]
0
0
Substudy 2: Percentage Of Participants With Mucosal Healing at Week 8
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Assessment method [17]
0
0
Mucosal healing is defined as an endoscopic score of 0 and Geboes score \< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
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Timepoint [17]
0
0
At Week 8
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Secondary outcome [18]
0
0
Substudy 2: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8
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Assessment method [18]
0
0
The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.
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Timepoint [18]
0
0
Baseline (Week 0), Week 8
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Secondary outcome [19]
0
0
Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52
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Assessment method [19]
0
0
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
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Timepoint [19]
0
0
At Week 52
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Secondary outcome [20]
0
0
Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
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Assessment method [20]
0
0
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 3, clinical remission is defined as SFS = 1 and not greater than Baseline, RBS of 0, and endoscopic subscore = 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Query!
Timepoint [20]
0
0
At Week 52
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Secondary outcome [21]
0
0
Substudy 3: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Wk 52 and Were Corticosteroid Free for = 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
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Assessment method [21]
0
0
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
For Substudy 3, clinical remission is defined as SFS = 1 and not greater than Baseline, RBS of 0, and endoscopic subscore = 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Query!
Timepoint [21]
0
0
At Week 52
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Secondary outcome [22]
0
0
Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment
Query!
Assessment method [22]
0
0
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Query!
Timepoint [22]
0
0
At Week 52
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Secondary outcome [23]
0
0
Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52
Query!
Assessment method [23]
0
0
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Query!
Timepoint [23]
0
0
At Week 52
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Secondary outcome [24]
0
0
Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment
Query!
Assessment method [24]
0
0
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score = 2 points and = 30% from baseline, and a decrease in RBS = 1 or an absolute RBS = 1).
Query!
Timepoint [24]
0
0
At Week 52
Query!
Secondary outcome [25]
0
0
Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52
Query!
Assessment method [25]
0
0
Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score = 3.1.
The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Query!
Timepoint [25]
0
0
At Week 52
Query!
Secondary outcome [26]
0
0
Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52
Query!
Assessment method [26]
0
0
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Query!
Timepoint [26]
0
0
Baseline (Week 0), Week 52
Query!
Secondary outcome [27]
0
0
Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52
Query!
Assessment method [27]
0
0
Mucosal healing is defined as an endoscopic score of 0 and Geboes score \< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Query!
Timepoint [27]
0
0
At Week 52
Query!
Secondary outcome [28]
0
0
Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52
Query!
Assessment method [28]
0
0
Bowel urgency was assessed by participants in a subject diary completed once a day.
Query!
Timepoint [28]
0
0
At Week 52
Query!
Secondary outcome [29]
0
0
Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52
Query!
Assessment method [29]
0
0
Abdominal pain was assessed by participants in a subject diary completed once a day.
Query!
Timepoint [29]
0
0
At Week 52
Query!
Secondary outcome [30]
0
0
Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52
Query!
Assessment method [30]
0
0
The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.
Query!
Timepoint [30]
0
0
Baseline (Week 0), Week 52
Query!
Eligibility
Key inclusion criteria
Note: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants =18 years old will be enrolled. Adolescents must weigh = 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.
* Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
* Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
* Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator.
Note: Participants who have had inadequate response, loss of response to conventional therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease) and must meet criteria for inadequate response, loss of response or intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.
* If female, participant must meet the criteria for Contraception Recommendations
* Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.
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Minimum age
16
Years
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Maximum age
75
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 current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC)
* Current diagnosis of fulminant colitis and/or toxic megacolon
* Participant with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy
* Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline
* Participant on azathioprine or 6-mercaptopurine within 10 days of Baseline
* Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
* Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
* Screening laboratory and other analyses show any abnormal results meeting the exclusion criteria
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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 administering the treatment/s
The people assessing the outcomes
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 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
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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
26/09/2016
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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
13/12/2021
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Sample size
Target
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Accrual to date
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Final
1302
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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0
Macquarie University Hospital /ID# 211951 - Macquarie University
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Recruitment hospital [2]
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Mater Misericordiae Limited /ID# 212685 - South Brisbane
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Recruitment hospital [3]
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Griffith University /ID# 211952 - Southport
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Monash Medical Centre /ID# 150206 - Clayton
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St Vincent's Hospital Melbourne /ID# 152472 - Fitzroy Melbourne
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Recruitment hospital [6]
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Fiona Stanley Hospital /ID# 211640 - Murdoch
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Recruitment postcode(s) [1]
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2109 - Macquarie University
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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4222 - Southport
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3168 - Clayton
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3065 - Fitzroy Melbourne
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment outside Australia
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Oita
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Yamaguchi
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Yamanashi
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Japan
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Takatsuki-shi
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Gyeonggido
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Seoul Teugbyeolsi
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United Kingdom
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Tooting
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
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Trial website
https://clinicaltrials.gov/study/NCT02819635
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Trial related presentations / publications
Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26. Erratum In: Lancet. 2022 Sep 24;400(10357):996. doi: 10.1016/S0140-6736(22)01069-8. Sandborn WJ, Ghosh S, Panes J, Schreiber S, D'Haens G, Tanida S, Siffledeen J, Enejosa J, Zhou W, Othman AA, Huang B, Higgins PDR. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020 Jun;158(8):2139-2149.e14. doi: 10.1053/j.gastro.2020.02.030. Epub 2020 Feb 22. Erratum In: Gastroenterology. 2020 Sep;159(3):1192. doi: 10.1053/j.gastro.2020.08.040.
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Public notes
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Contacts
Principal investigator
Name
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0
ABBVIE INC.
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Address
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AbbVie
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Contact person for public queries
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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/35/NCT02819635/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/35/NCT02819635/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02819635