Efficacy and Tolerability of BAF312 in Patients With Polymyositis

• Status: Terminated
• Trial end date: 2016-08-05
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Siponimod

Criteria

Inclusion Criteria:

• "definite" or "probable" for polymyositis at least three months before Baseline

• active disease as defined by elevated CK levels, or other enzymes, or MRI/biopsy if enzymes are normal, and persisting muscle weakness

• stable dose of corticosteroid for at least 2 weeks prior to Baseline and should not have received a medium or high dose in the last 8 weeks prior to study entry.

• patients treated with methotrexate must have been on a stable dose for at least 6 weeks prior to Baseline.

Exclusion Criteria:

• Patients with overlap polymyositis, late-stage polymyositis, or other types of myositis.

• Preexisting severe cardiac or pulmonary involvement, malignancy of any organ system or significant eye diseases.

• Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.

• Pregnant or nursing (lactating) women