Evaluating 2 Treatment Algorithms in Moderate-severe Crohn's disease
Research type
Research Study
Full title
An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease
IRAS ID
58047
Contact name
Simon Travis
Sponsor organisation
Abbott Laboratories Limited
Eudract number
2010-020137-10
ISRCTN Number
N/A
Research summary
The current treatments prescribed for the treatment of Crohn's disease (CD) do not completely stop the inflammatory process and have significant side effects. Treatments include anti-inflammatory agents (also known as steroids, such as prednisone), immunomodulators (drugs that treat disorders of the immune system such as azathioprine) and biologic agents (for example adalimumab). In this study prednisone, azathioprine and adalimumab will be used as study medications. This study will compare two treatment strategies for patients with moderate to severe CD, the aim is to show that tight control of disease activity using strict criteria based clinical symptoms, blood tests and steroid use improves the rate of mucosal healing (mucosa is membrane layer of the intestines) at Week 56, as compared to treating patients using less strict criteria based on clinical symptoms and steroid use only.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
10/H0402/55
Date of REC Opinion
20 Sep 2010
REC opinion
Further Information Favourable Opinion