M10-870 Adalimumab in Paediatric Ulcerative Colitis (Extension)
Research type
Research Study
Full title
A Multi-Center, Open-Label Study of the Human Anti TNF Monoclonal Antibody 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
IRAS ID
192395
Contact name
Daniel Kreeb
Contact email
Sponsor organisation
Abbvie Deutschland GmbH & Co. KG
Eudract number
2015-001346-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This study is a Phase 3, multi-center, open-label study designed to evaluate the long-term maintenance of clinical response, safety and tolerability of adalimumab in paediatric subjects with ulcerative colitis. Approximately 70 sites worldwide (and 10 sites from Japan) that have enrolled subjects in the Study M11-290 clinical trial will participate in the Study M10-870 clinical trial. Approximately 85 paediatric subjects from the main study and an approximately 8 subjects from the Japanese sub-study are expected to enroll in this study.
The Week 52 visit from the Study M11-290 will serve as the Baseline Visit for subjects entering Study M10-870.
Subjects will be allowed to enroll in the Study M10-870 if they have successfully completed Protocol M11-290 through Week 52 and meet all of the inclusion criteria and none of the exclusion criteria for Study M10-870.REC name
West of Scotland REC 1
REC reference
16/WS/0023
Date of REC Opinion
8 Feb 2016
REC opinion
Unfavourable Opinion