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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02782663
Registration number
NCT02782663
Ethics application status
Date submitted
23/05/2016
Date registered
25/05/2016
Titles & IDs
Public title
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
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Scientific title
A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease
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Secondary ID [1]
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2015-003759-23
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Secondary ID [2]
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M14-327
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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 (CD)
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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 - ABT-494
Experimental: Upadacitinib (ABT-494) Dose A - Open label dose A once daily (QD)
Experimental: Upadacitinib (ABT-494) Dose B - Open label dose B QD
Treatment: Drugs: ABT-494
Tablet: Oral
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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 Achieving Remission
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Assessment method [1]
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It is defined as the percentage of participants achieving clinical remission and endoscopic remission.
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Timepoint [1]
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Up to Month 96
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Primary outcome [2]
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Percentage of Participants in Remission at Week 0 Who Maintain Remission
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Assessment method [2]
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Remission is defined as participants achieving clinical remission and endoscopic remission.
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Timepoint [2]
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Up to Month 96
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Primary outcome [3]
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Percentage of Participants Achieving Response
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Assessment method [3]
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It is defined as the percentage of participants achieving clinical response and endoscopic response.
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Timepoint [3]
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Up to Month 96
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Primary outcome [4]
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Percentage of Participants Achieving Clinical Remission
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Assessment method [4]
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Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
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Timepoint [4]
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Up to Month 96
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Primary outcome [5]
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Percentage of Participants Achieving Modified Clinical Remission
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Assessment method [5]
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Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
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Timepoint [5]
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Up to Month 96
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Primary outcome [6]
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Percentage of Participants Achieving Enhanced Clinical Response
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Assessment method [6]
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Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
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Timepoint [6]
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Up to Month 96
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Primary outcome [7]
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Percentage of Participants Achieving Clinical Response
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Assessment method [7]
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Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
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Timepoint [7]
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Up to Month 96
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Primary outcome [8]
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Percentage of Participants Achieving Endoscopic Remission
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Assessment method [8]
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Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
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Timepoint [8]
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Up to Month 96
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Primary outcome [9]
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Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission
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Assessment method [9]
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Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
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Timepoint [9]
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Up to Month 96
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Primary outcome [10]
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Percentage of Participants Achieving Endoscopic Improvement
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Assessment method [10]
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Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission.
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Timepoint [10]
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Up to Month 96
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Primary outcome [11]
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Percentage of Participants Achieving Endoscopic Response
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Assessment method [11]
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Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease.
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Timepoint [11]
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Up to Month 96
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Primary outcome [12]
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Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission
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Assessment method [12]
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It is defined as CDAI less than 150.
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Timepoint [12]
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Up to Month 96
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Primary outcome [13]
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Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response
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Assessment method [13]
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CDAI response is defined as a reduction in CDAI by \>= 70 from baseline of Study M13-740.
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Timepoint [13]
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Up to Month 96
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Primary outcome [14]
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Percentage of Participants Achieving Enhanced CDAI Response
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Assessment method [14]
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Enhanced CDAI response is defined as reduction in CDAI by \>= 100 from baseline of Study M13-740.
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Timepoint [14]
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Up to Month 96
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Primary outcome [15]
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Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission
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Assessment method [15]
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IBDQ remission is defined as IBDQ \>= 170.
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Timepoint [15]
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Up to Month 96
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Primary outcome [16]
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Percentage of Participants Achieving IBDQ Response
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Assessment method [16]
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IBDQ response is defined as an increase in IBDQ score \>= 16 point from Baseline of Study M13-740.
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Timepoint [16]
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Up to Month 96
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Primary outcome [17]
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Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free
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Assessment method [17]
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Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free
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Timepoint [17]
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Up to Month 96
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Primary outcome [18]
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Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission
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Assessment method [18]
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Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free for at least 90 days over time and achieve Remission
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Timepoint [18]
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Up to Month 96
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Primary outcome [19]
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Percentage of Participants Achieving Remission and Normal C-Reactive Protein
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Assessment method [19]
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Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission.
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Timepoint [19]
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Up to Month 96
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Eligibility
Key inclusion criteria
* Participant must have completed Study M13-740 through Week 52.
* If female, participant must be postmenopausal, surgically sterile or on using a birth control method.
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Minimum age
18
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
* For any reason participant is considered by the investigator to be an unsuitable candidate
* Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
* Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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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
Active, not recruiting
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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
18/05/2016
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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
17/09/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
107
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kansas
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Kentucky
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United States of America
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Maryland
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United States of America
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Michigan
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Oklahoma
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Hradec Kralove
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Nord
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HaMerkaz
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Tel-Aviv
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Lodzkie
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Nitriansky Kraj
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Presovsky Kraj
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Spain
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A Coruna
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Spain
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Madrid
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United Kingdom
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Oxfordshire
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United Kingdom
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Manchester
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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
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
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Trial website
https://clinicaltrials.gov/study/NCT02782663
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Trial related presentations / publications
D'Haens G, Panes J, Louis E, Lacerda A, Zhou Q, Liu J, Loftus EV Jr. Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2337-2346.e3. doi: 10.1016/j.cgh.2021.12.030. Epub 2021 Dec 27.
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Public notes
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Contacts
Principal investigator
Name
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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, analyses plans, 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), Analytic code
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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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
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02782663