OBJECTIVE: @entity205 and @entity1500 are used in idiopathic @entity5442 ( @entity3918 and PM) when @entity1 incompletely respond to glucocorticoids. Their effectiveness is unproved in randomized controlled trials (RCTs). We evaluated their benefits in a placebo-controlled factorial RCT. METHODS: A 56-week multicentre factorial-design double-blind placebo-controlled RCT compared @entity230 alone, @entity1500 (15-25 mg weekly) plus @entity230 , @entity205 (1-5 mg/kg/day) plus @entity230 and all three treatments. It enrolled adults with @entity5442 (by Bohan and Peter criteria) with @entity66 receiving corticosteroids. RESULTS: A total of 359 @entity1 were screened and 58 randomized. Of the latter, 37 @entity1 completed 12 months of treatment, 7 were lost to follow-up and 14 discontinued treatment. @entity1 completing 12 months of treatment showed significant improvement (P < 0.001 on paired t-tests) in manual muscle testing (14% change), walking time (22% change) and function (9% change). Intention to treat and completer analyses indicated that @entity205 monotherapy, @entity1500 monotherapy and @entity205 / @entity1500 combination therapy showed no significant treatment effects in comparison with placebo. CONCLUSION: Neither @entity1500 nor @entity205 (by themselves or in combination) improved clinical features in @entity5442 @entity1 who had incompletely responded to glucocorticoids. Trial Registration: International Standard Randomized Controlled Trial Number Register; http://www.controlled-trials.com/; ISRCTN40085050.

Second-line agents in @entity5442 : 1-year factorial trial of additional immunosuppression in @entity1 who have partially responded to XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity5442 :: ('MESH:D009220', 'Disease') :: ['myositis', 'inflammatory myopathies'] @entity66 :: ('MESH:D004194', 'Disease') :: ['active disease'] @entity205 :: ('MESH:D016572', 'Chemical') :: ['Ciclosporin', 'ciclosporin'] @entity1500 :: ('CHEBI:44185', 'Chemical') :: ['MTX'] @entity230 :: ('MESH:D013256', 'Chemical') :: ['steroids'] @entity3918 :: ('MESH:D009223', 'Disease') :: ['DM']
@entity230 :: (MESH:D013256,Chemical) :: ['steroids']
