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: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-001346-29-BE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- 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 Main Objective: The objective of the study is to evaluate the long-term safety, tolerability, and maintenance of clinical response, of repeated administration of adalimumab in pediatric subjects with ulcerative colitis who participated in, and successfully completed, Protocol M11-290 through Week 52.;Secondary Objective: Not applicable;Primary end point(s): This study will utilize the PMS (and Mayo score if available) and PUCAI to determine efficacy of the study drug;Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96/Premature Discontinuation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety analyses will be performed on all subjects who receive at least one dose of study drug. ;Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96/Premature Discontinuation