Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

Novartis

Status and phase: Terminated; Phase 2

Conditions: Dermatomyositis; Polymyositis

Treatments: Drug: Placebo; Drug: BAF312

Study type: Interventional

Funder types: Industry

Identifiers

NCT01148810

2008-006311-21 (EudraCT Number)

CBAF312A2202

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Other idiopathic inflammatory myopathies
• Myopathy other than polymyositis and dermatomyositis
• Patients with late stages of disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

BAF312

Experimental group

Treatment:

Drug: BAF312