Randomised study of Adalimumab in subjects with Ulcerative Colitis.
Research type
Research Study
Full title
A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
IRAS ID
155603
Contact name
Simon Travis
Contact email
Sponsor organisation
Abbvie Deutschland GmbH & Co. KG
Eudract number
2013-001682-16
Research summary
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that affects the large intestine and rectum. Commonly it causes effects like diarrhoea, blood in the stool, stomach ache. This may in turn cause problems like low levels of red blood cells, weight loss and feeling fatigue.
The background to the disease is related to the body´s immune response attacking the gastrointestinal tract which leads to inflammation. It is a disease that may go into remission or response, followed by relapse, where the patient has a period with less symptoms followed by a period with more symptoms. The aim of medical treatment in UC is to control inflammation and reduce symptoms.
The safety and efficacy of adalimumab for the induction and maintenance of clinical remission in adult subjects with moderately to severely active UC has been studied in two completed clinical trials. The purpose of this study is to evaluate a higher induction and maintenance regimen, including an exploratory arm evaluating a therapeutic drug monitoring strategy, than the standard approved adalimumab induction for induction and maintenance therapy in adult patients with moderately to severely active ulcerative colitis. This study is designed to fulfill the two post-marketing requirements (PMR) that were part of the US approval of adalimumab in adult patients with UC.
The study will be conducted in several countries within and outside of Europe. In total about 525 persons are planned to participate. The participation of the individual person will be about 65 weeks long and consists of 17 visits to the clinic.
REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/1068
Date of REC Opinion
30 Jun 2014
REC opinion
Favourable Opinion