notes (if applicable):
|Why this is important:- The evidence for use of this group of drugs for maintenance of remission in Crohn's disease is not clear, and in particular, there is very limited reporting of disease site. It is therefore possible that this might be a cost-effective treatment for maintenance of remission, with limited toxicity. Its use in this setting may therefore be associated with higher rates of successful maintenance of disease remission, reduced need for escalation of therapy, higher quality of life, and lower rates of hospital admissions and surgeries. The question is applicable to adults, young people and
children, and trials in all are therefore required. A conventional glucocorticosteroid would be offered to induce remission in a first presentation of colonic Crohn's disease. Patients would be recruited once in remission and glucocorticosteroid-free and randomised to receive mesalazine or placebo, for maintenance of remission. Co-primary end points would be quality of life measures and maintenance of glucocorticosteroid-free remission measured by the Crohn's Disease Activity Index (CDAI). Secondary end points would be mucosal healing at endoscopy, need for escalation of therapy to azathioprine or biological therapy, adverse events, hospitalisation and surgery. The time frame for follow-up should be at least 12 months, but ideally 24â??36 months.