Conditions: Polymyositis
Keywords: Polymyositis Myositis PM chronic muscle inflammation inflammatory myopathy inclusion body myositis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14
Healthy volunteers: no

Brief summary:
This study assessed the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with polymyositis who had shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic drugs).

Detailed description:
This study was stopped prematurely due to overall slow recruitment and no evidence for efficacy in a parallel study in dermatomyositis with an assumed similar pathophysiology. With very small sample sizes per group the overall results for this study including primary and all other efficacy and PD data are inconclusive

Arms:
arm 1: 5 placebo tablets daily during non-titration phase arm 2: 1 tablet of BAF312 2 mg + 4 tablets of Placebo daily during non-titration phase arm 3: 5 tablets of BAF312 2 mg daily during non-titration phase

Interventions: intervention 1: Placebo intervention 2: BAF312
Intervention descriptions: intervention 1: Matching placebo tablet for oral administration intervention 2: BAF312 in 4 dosage strengths in tablet form: 0.25 mg, 0.5 mg, 1 mg, 2 mg for oral administration

Protocol document: