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
Phase 2
Recruiting
- Conditions
- chronic inflammation of the intestineregional enteritis1001796910003816
- Registration Number
- NL-OMON50581
- Lead Sponsor
- AbbVie B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
Subject must have completed Study M13-740 through Week 52.
Exclusion Criteria
• For any reason subject is considered by the investigator to be an unsuitable
candidate, • Female subject with a positive pregnancy test at Baseline or who
is considering becoming pregnant during the study. , • Subject is not in
compliance with prior and concomitant medication requirements and procedures
throughout Study M13-740.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Proportion of subjects achieving Remission at Week 0 (Week 52 of Study<br /><br>M13-740), Month 12, 24, 36, 48, 60, 72, 84, and 96<br /><br>• Proportion of subjects achieving Response at Week 0 (Week 52 of Study<br /><br>M13-740), Month 12, 24, 36, 48, 60, 72, 84, and 96<br /><br>• Proportion of subjects in remission at week 0 who maintain remission at Month<br /><br>12, 24, 36, 48, 60, 72, 84, and 96</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Proportion of subjects achieving Clinical remission over time<br /><br>• Proportion of subjects achieving Clinical response over time<br /><br>• Proportion of subjects achieving Endoscopic remission at Week 0 (Week 52 of<br /><br>Study M13-740), Month 12, 24, 36, 48, 60, 72, 84, and 96<br /><br>• Proportion of subjects achieving Endoscopic response at Week 0 (Week 52 of<br /><br>Study M13-740), Month 12, 24, 36, 48, 60, 72, 84, and 96<br /><br>• Proportion of subjects achieving CDAI remission over time<br /><br>• Proportion of subjects achieving CDAI response over time<br /><br>• Proportion of subjects achieving IBDQ remission over time<br /><br>• Proportion of subjects achieving IBDQ response over time<br /><br>• Proportion of subjects in Remission, and hs-CRP < 5 mg/L, and fecal<br /><br>calprotectin < 250 µg/g at Week 0 (Week 52 of Study M13-740), Month 12, 24, 36,<br /><br>48, 60, 72, 84, and 96</p><br>