notes (if applicable):
|Why this is important:- Crohn's disease runs a relapsing and remitting course, with a significant inflammatory component during its early stages, and increasing degrees of fibrotic, stenosing or perforating disease later. Intervention during the inflammatory stage may affect disease progression while avoiding the side effects of glucocorticosteroid treatment â?? the current mainstay of treatment for
exacerbations. Adults and children with a first presentation of intestinal Crohn's disease would be recruited once in remission and randomised to receive azathioprine or placebo for preventing relapse after an initial treatment with a glucocorticosteroid. Co-primary end points would be quality of life measures and maintaining glucocorticosteroid-free remission measured by the Crohn's Disease Activity Index (CDAI). Secondary end points would be mucosal healing at endoscopy, hospitalisation, side effects and surgery. Appropriate healthcare costs would also need to be assessed to inform a cost-effectiveness model. Follow-up should be at least 2 years, and ideally 5 years.