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 1
- Conditions
- Crohn's DiseaseMedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-003759-23-SK
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
Subject must have completed Study M13-740 through Week 52.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To observe the long-term efficacy, safety, and tolerability of repeated administration of upadacitinib in subjects with Crohn's disease (CD) who completed Study M13-740.;Secondary Objective: Not applicable;Primary end point(s): • Proportion of subjects achieving Remission at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96. <br>• Proportion of subjects in Remission at Week 0 who maintain remission at Months 12, 24, 36, 48, 60, 72, 84, and 96.<br>• Proportion of subjects achieving Response at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96.;Timepoint(s) of evaluation of this end point: Every 12 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Proportion of subjects in Remission, and hs-CRP < 5 mg/L, and fecal calprotectin < 250 µg/g at Week 0 (Week 52 of Study M13-740), Month 12, Month 24, Month 36, Month 48, Month 60, Month 72, Month 84 and Month 96.<br>;Timepoint(s) of evaluation of this end point: Every 12 months