A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290
Phase 1
- Conditions
- lcerative ColitisMedDRA version: 20.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000016670Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-001346-29-SE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 93
Inclusion Criteria
Subject must have successfully enrolled in and completed Protocol M11-290 through Week 52.
Are the trial subjects under 18? yes
Number of subjects for this age range: 93
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for continuing therapy in the Study M10-870.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method