Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-15

Study Completion Date

2012-06-13

Brief Summary

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This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive to traditional immunosuppressive and/or corticosteroid therapy. The study consisted of a 12 week, randomized, placebo controlled period, followed by another 12 weeks where all subjects received BAF312 treatment.

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Detailed Description

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Conditions

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Polymyositis Dermatomyositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

BAF312

Group Type EXPERIMENTAL

BAF312

Intervention Type DRUG

Interventions

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BAF312

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with disease at least 3 months before study
* Muscle weakness
* Received corticosteroids with or with out disease modifying antirheumatic drugs at least 3 months before study however not responding to this therapy