BACKGROUND: @entity4184 is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid inactivation. We have assessed the efficacy and safety of an oral controlled ileal release (CIR) preparation of @entity4184 for maintenance of remission in @entity1 with ileal or ileocaecal @entity30 . METHODS: In a double-blind, multicentre trial, 75 @entity1 in clinical remission ( @entity30 Activity Index, @entity4844 , < or = 150) were randomly assigned to receive placebo, @entity4184 3 mg or @entity4184 6 mg daily for 12 months. Trial drugs were given at a fixed dose and without concomitant medication. The primary outcome measure was relapse, defined as a @entity4844 > 150 together with an increase of at least 60 units from entry. A @entity1 was also considered to have a relapse if withdrawn from the study due to clinical deterioration, whether or not a @entity4844 value could be calculated at that time. RESULTS: There were no statistically significant differences in the relapse rate at any time-point throughout the study. By 12 months the proportion of @entity1 having relapsed were 48, 46 and 60% in those @entity1 treated with @entity4184 6 mg, 3 mg and placebo, respectively (N.S.). Treatments were well tolerated, and the proportion of @entity1 with suppressed adrenal function (according to predetermined criteria) were 50% (6 mg), 26% (3 mg) and 17% (placebo) (P = 0.096). CONCLUSIONS: In the present study, relapse rate and time to relapse were similar in the @entity1 treated with @entity4184 CIR, 6 mg daily or 3 mg daily or with placebo, throughout 12 months. This is in contrast to the two previous trials with identical design, where a significant effect of @entity4184 CIR in prolonging the median time to relapse was found. Possible reasons for the negative results of the present study include small sample size, and the fact that there was a high placebo response.

Oral @entity4184 as maintenance therapy in XXXX --results of a 12-month study. Global @entity4184 Study Group.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity30 :: ('MESH:D003424', 'Disease') :: ["Crohn's Disease", "Crohn's disease"] @entity4184 :: ('MESH:D019819', 'Chemical') :: ['Budesonide', 'budesonide'] @entity4844 :: ('146059', 'Gene') :: ['CDAI']
@entity30 :: (MESH:D003424,Disease) :: ['Crohn's disease']
