Clinical Trial: Efficacy and Tolerability of BAF312 in Patients With Polymyositis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Combined efficacy endpoint: Manual Muscle Testing (MMT) and serum creatine kinase (CK) levels, or other enzymes, or MRI/biopsy if enzymes are normal. [ Time Frame: 12 weeks ]

Assessment of preliminary clinical efficacy of 2mg and 10mg BAF312 once daily using MMT of 24 muscles (MMT-24) and serum CK levels, or other enzymes, or MRI/biopsy if enzymes are normal.


Original Primary Outcome: Combined efficacy endpoint: Manual Muscle Testing (MMT) and serum creatine kinase (CK) levels [ Time Frame: 12 weeks ]

Assessment of preliminary clinical efficacy of 2mg BAF312 once daily using MMT of 8 muscles (MMT-8) and serum CK levels


Current Secondary Outcome: Adverse Events (AEs), 6 minute walking distance test (MWD) and pharmacokinetics [ Time Frame: 24 weeks for AEs and 12 weeks for 6MWD ]

Number of adverse events will be tabulated by body systems and treatment. Distance traveled over a 6 minute time period will be measured. Steady state pharmacokinetics of BAF312 will be characterized.


Original Secondary Outcome: Adverse Events [ Time Frame: 24 weeks ]

Number and percentage of adverse events will be tabulated by body systems and treatment.


Information By: Novartis

Dates:
Date Received: February 1, 2013
Date Started: April 2013
Date Completion:
Last Updated: February 19, 2017
Last Verified: February 2017