A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
- Registration Number
- NCT02782663
- Lead Sponsor
- AbbVie
- Brief Summary
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 107
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Upadacitinib (ABT-494) Dose A ABT-494 Open label dose A once daily (QD) Upadacitinib (ABT-494) Dose B ABT-494 Open label dose B QD
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Remission Up to Month 96 It is defined as the percentage of participants achieving clinical remission and endoscopic remission.
Percentage of Participants Achieving Enhanced Clinical Response Up to Month 96 Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Modified Clinical Remission Up to Month 96 Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Clinical Response Up to Month 96 Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission Up to Month 96 IBDQ remission is defined as IBDQ \>= 170.
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission Up to Month 96 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
Percentage of Participants Achieving Remission and Normal C-Reactive Protein Up to Month 96 Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission.
Percentage of Participants Achieving Clinical Remission Up to Month 96 Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Endoscopic Improvement Up to Month 96 Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission.
Percentage of Participants Achieving Enhanced CDAI Response Up to Month 96 Enhanced CDAI response is defined as reduction in CDAI by \>= 100 from baseline of Study M13-740.
Percentage of Participants in Remission at Week 0 Who Maintain Remission Up to Month 96 Remission is defined as participants achieving clinical remission and endoscopic remission.
Percentage of Participants Achieving Response Up to Month 96 It is defined as the percentage of participants achieving clinical response and endoscopic response.
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission Up to Month 96 It is defined as CDAI less than 150.
Percentage of Participants Achieving Endoscopic Remission Up to Month 96 Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission Up to Month 96 Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
Percentage of Participants Achieving Endoscopic Response Up to Month 96 Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease.
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response Up to Month 96 CDAI response is defined as a reduction in CDAI by \>= 70 from baseline of Study M13-740.
Percentage of Participants Achieving IBDQ Response Up to Month 96 IBDQ response is defined as an increase in IBDQ score \>= 16 point from Baseline of Study M13-740.
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free Up to Month 96 Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
UC San Diego Health System /ID# 150041
🇺🇸La Jolla, California, United States
Univ California, San Francisco /ID# 149987
🇺🇸San Francisco, California, United States
Duplicate_University of Florida - Archer /ID# 150033
🇺🇸Gainesville, Florida, United States
The Ctr for Gastro Disorders /ID# 150012
🇺🇸Hollywood, Florida, United States
Nature Coast Clinical Research - Inverness /ID# 149975
🇺🇸Inverness, Florida, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 149870
🇺🇸Macon, Georgia, United States
GI Specialists of GA, PC /ID# 150015
🇺🇸Marietta, Georgia, United States
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900
🇺🇸Topeka, Kansas, United States
Duplicate_University of Louisville /ID# 149884
🇺🇸Louisville, Kentucky, United States
Investigative Clinical Research /ID# 149886
🇺🇸Annapolis, Maryland, United States
Scroll for more (51 remaining)UC San Diego Health System /ID# 150041🇺🇸La Jolla, California, United States