Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Polymyositis, Dermatomyositis
In brief
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.
Key facts
- Study ID
- NCT01148810
- Run by
- Novartis Pharmaceuticals
- People needed
- 18
- Starts
- 2010-06-15
- Expected to finish
- 2012-06-13
- Last updated by the study team
- 2019-04-25
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Other idiopathic inflammatory myopathies
- Myopathy other than polymyositis and dermatomyositis
- Patients with late stages of disease
Where it is running
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — Prague, Czechia
- Novartis Investigative Site — Budapest, Hungary
- Novartis Investigative Site — Debrecen, Hungary
- Novartis Investigative Site — Stockholm, Sweden
- Novartis Investigative Site — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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