Randomised study of Adalimumab in subjects with Crohn's Disease
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration
IRAS ID
150228
Contact name
Fraser Cummings
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2013-001746-33
Research summary
Crohn´s disease (CD) is a chronic inflammatory bowel disease caused by a dysregulated immune response to environmental factors including the gut microbiota in genetically susceptible individuals causing inflammation of tany part of the gastrointestinal tract. It is a disease that alternates between periods of no activity i.e. the patient has very little symptoms and periods of relapse, i.e. the patient is symptomatic.
Traditionally treatment for CD has been focused on symptomatic improvement and achievement of remission. It has been shown that patients with on-going endoscopic evidence of ulceration of the gut mucosa are at increased risk of experiencing disease complications which may result in surgery and other poor outcomes for patients. Therefore, it is reasonable that another goal of therapy be the improvement/complete healing of the gut mucosal as visualized at endoscopy; this has been found to be associated with positive clinical benefits, including higher rates of clinical remission, fewer hospitalizations, and fewer abdominal surgeries.
Adalimumab is a standard, licensed drug treatment for CD as well as a number of other inflammatory diseases. Previous studies with adalimumab suggest that higher doses of the drug, may improve the chances of healing the gut mucosa. Patients normally receive a higher dose when they start treatment (induction) before going onto a lower maintenance dose. This study is designed to investigate the effectiveness and safety of using a higher dose induction regime (160mg every week for 4 weeks) as compared the standard regime (160mg followed by 80mg 2 weeks later), before all patients go onto standard maintenance treatment (40mg every other week). This will be evaluated in adult patients with moderately to severely active Crohn´s and measured with evidence of mucosal ulceration.
The study will take place in several countries within and outside of Europe, the study duration will be 15 weeks long and consists of 7 visits to the clinic, 300 people are planned to participate.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1047
Date of REC Opinion
7 Oct 2014
REC opinion
Further Information Favourable Opinion