Efficacy and Tolerability of BAF312 in Patients With Polymyositis
This study will assess the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis who have shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic drugs).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multi-centre Double-blind, Placebo Controlled, Proof of Concept Study to Evaluate the Efficacy and Tolerability of BAF312 in Patients With Polymyositis|
- Combined efficacy endpoint: Manual Muscle Testing (MMT) and serum creatine kinase (CK) levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Assessment of preliminary clinical efficacy of 2mg BAF312 once daily using MMT of 8 muscles (MMT-8) and serum CK levels
- Adverse Events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Number of adverse events will be tabulated by body systems and treatment.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Patients randomized to active treatment will undergo a titration period of 6 days with BAF312. From day 6 patients will receive BAF312 (2 mg) for the entire duration of Period 1. Both patients randomized on active and on placebo will be offered to enter in the all-active extension Period 2, after the completion of Period 1.
|Contact: Novartis Pharmaceuticals||1-888-669-6682|
|Contact: Novartis Pharmaceuticals|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|