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Efficacy and Tolerability of BAF312 in Patients With Polymyositis

Polymyositis Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01801917
Study type Interventional
Source Novartis
Contact
Status Terminated
Phase Phase 2
Start date April 24, 2013
Completion date August 5, 2016
View Details
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