M11-290, Adalimumbab Paediatric Ulcerative Colitis Study
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.
IRAS ID
143053
Contact name
Richard Russell
Contact email
Sponsor organisation
Abbvie Deutschland GmbH & Co. KG
Eudract number
2013-003032-77
Clinicaltrials.gov Identifier
Research summary
This is a study designed to study the effectiveness and safety of the human anti-TNF monoclonal antibody adalimumab in children aged 4-17 with ulcerative colitis (UC). UC is a condition which commonly causes children to have problems with abdominal pain, weight loss and bloody diarrhoea. At present current treatments do not always control these problems with 1 in 4 children needing an operation to remove their large bowel while they are a child. Approximately 225 children with moderate-to-severe UC will be enrolled at approximately 70 sites worldwide, for the main study (and 20 subjects for the Japan sub-study at approximately 10 sites in Japan). The medicine will be given to children who have not responded to more established treatments to try and control the symptoms of their disease.
REC name
West of Scotland REC 1
REC reference
14/WS/1078
Date of REC Opinion
30 Oct 2014
REC opinion
Further Information Favourable Opinion