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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03653026
Registration number
NCT03653026
Ethics application status
Date submitted
28/08/2018
Date registered
31/08/2018
Titles & IDs
Public title
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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2016-000642-62
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Secondary ID [2]
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M14-675
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Universal Trial Number (UTN)
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Trial acronym
U-Accomplish
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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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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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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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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
Experimental: Upadacitinib 45 mg - Participants received 45 mg upadacitinib once daily (QD) for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.
Placebo comparator: Placebo - Participants received placebo matching to upadacitinib once daily for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.
Treatment: Drugs: Placebo
Tablet for oral administration
Treatment: Drugs: Upadacitinib
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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Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
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Assessment method [1]
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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 remission is defined as an Adapted Mayo score = 2, with SFS = 1 and not higher than Baseline, RBS of 0, and endoscopic subscore = 1.
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Timepoint [1]
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Week 8
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Secondary outcome [1]
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Percentage of Participants With Endoscopic Improvement at Week 8
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Assessment method [1]
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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]
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Week 8
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Secondary outcome [2]
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Percentage of Participants With Endoscopic Remission at Week 8
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Assessment method [2]
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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 [2]
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Week 8
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Secondary outcome [3]
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Percentage of Participants Who Achieved Clinical Response Per Adapted Mayo Score at Week 8
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Assessment method [3]
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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 with spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 with higher scores representing more severe disease.
Clinical response per the Adapted Mayo Score is defined as a decrease in 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 [3]
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Week 8
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Secondary outcome [4]
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Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at Week 2
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Assessment method [4]
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The Partial Adapted 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 Adapted Mayo score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical response per Partial Adapted Mayo Score is defined as a decrease in Partial Adapted Mayo score = 1 point and = 30% from Baseline, plus a decrease in RBS = 1 or an absolute RBS = 1.
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Timepoint [4]
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Week 2
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Secondary outcome [5]
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Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
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Assessment method [5]
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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 [5]
0
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Week 8
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Secondary outcome [6]
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Percentage of Participants Who Reported No Bowel Urgency at Week 8
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Assessment method [6]
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Bowel urgency was assessed by participants in a subject diary completed once a day.
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Timepoint [6]
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Week 8
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Secondary outcome [7]
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Percentage of Participants Who Reported No Abdominal Pain at Week 8
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Assessment method [7]
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Abdominal pain was assessed by participants in a subject diary completed once a day.
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Timepoint [7]
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Week 8
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Secondary outcome [8]
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Percentage of Participants Who Achieved Histologic Improvement at Week 8
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Assessment method [8]
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Histologic improvement is defined as a decrease from Baseline in Geboes score. 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 [8]
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Week 8
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Secondary outcome [9]
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8
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Assessment method [9]
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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 [9]
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Baseline (Week 0) to Week 8
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Secondary outcome [10]
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Percentage of Participants Who Achieved Mucosal Healing at Week 8
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Assessment method [10]
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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 [10]
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Week 8
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Secondary outcome [11]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8
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Assessment method [11]
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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 [11]
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Baseline (Week 0) to Week 8
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Eligibility
Key inclusion criteria
- Male or female participants = 16 and = 75 years of age at Baseline Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.
Note: Adolescent participants at the age of 16 or 17 years old must weigh = 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.
* Diagnosis of Ulcerative Colitis (UC) 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 UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
* Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.
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 as defined above.
* 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.
* If female, participant must meet the contraception recommendation criteria.
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Minimum age
16
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Maximum age
75
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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 who received azathioprine or 6-mercaptopurine (6-MP) 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 prespecified abnormal hematologic results.
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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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/12/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/01/2021
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Sample size
Target
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Accrual to date
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Final
522
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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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Macquarie University Hospital /ID# 211955 - Macquarie University
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Recruitment hospital [2]
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Duplicate_Mater Misericordiae /ID# 212687 - South Brisbane
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Griffith University /ID# 211956 - Southport
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St Vincent's Hospital Melbourne /ID# 205758 - Fitzroy
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Monash Medical Centre /ID# 206486 - Melbourne
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Recruitment hospital [6]
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Fiona Stanley Hospital /ID# 211642 - 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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4222 - Southport
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3065 - Fitzroy
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3168 - 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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Split
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United Kingdom
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Whitechapel
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).
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Trial website
https://clinicaltrials.gov/study/NCT03653026
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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.
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Public notes
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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
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0
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Phone
0
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Fax
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Email
0
0
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Contact person for public queries
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0
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Address
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Fax
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Email
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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/26/NCT03653026/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/26/NCT03653026/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03653026