REACT2
Research type
Research Study
Full title
A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn’s Disease. Randomized Evaluation of an Algorithm for Crohn’s Treatment – Study 2 (REACT2)
IRAS ID
156047
Contact name
Vipul Jairath
Contact email
Sponsor organisation
Robarts Clinical Trials Inc.
Eudract number
2014-001050-41
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
EudraCT number, 2014-001050-41
Research summary
Crohn’s disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. The majority of patients require long-term medications to control inflammation and keep the disease in remission. Some patients will require surgery to remove diseased sections of intestine, which is likely to occur if inflammation is not adequately controlled. Ideally, strategies should be employed to maintain patients in long-term remission which minimise exposure to steroids and reduce therapy-related toxicity.
In reality many patients with CD do not receive effective therapy and their disease often remain active, leading to uncontrolled inflammation and complications from either underlying disease or steroids.
Physicians use care plans called algorithms, to guide treatment for illnesses like CD. The more conventional approach to management of CD is to start with less aggressive therapy, and if those fail, move to more aggressive therapy. The problem with this approach is that this is a gradual process and treatment is guided by improvement in symptoms in response to a given therapy. In actual clinical practice, delays occur in re-evaluating patients, resulting in prolonged exposure to steroids. In addition, using symptoms to guide therapy is problematic since both patients and physicians underestimate disease severity. The consequence is that patients tend to be undertreated, putting them at risk for complications of the disease. Recent studies in rheumatoid arthritis and CD have shown that starting combined therapy earlier may change how disease progresses over time. These studies also suggest that combined therapy may be better than single therapy.
The purpose of this research study is to compare two care plans (algorithms) for the management of CD. The study algorithms may help to reduce the risk of complications from CD and its treatment with steroids and other drugs. The study will look at whether, or not, the Enhanced algorithm improves CD treatment when compared to the more traditional Step-care algorithm. Both approaches are within the realms of normal care, but clinicians are uncertain as to which approach reduces the risk of complications in CD.
Thirty gastroenterology centres will participate in the study globally and will be randomly assigned to one of two algorithms (Step-care or Enhanced care). Approximately six centres will participate in the UK. Forty patients will be enrolled at each centre. The study will last for one year.REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1092
Date of REC Opinion
2 Sep 2014
REC opinion
Further Information Favourable Opinion