Trials / Terminated
TerminatedNCT01148810
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
A Multi-centre, Double-blind, Placebo Controlled, Proof of Concept Study to Evaluate the Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAF312 | |
| DRUG | Placebo |
Timeline
- Start date
- 2010-06-15
- Primary completion
- 2012-06-13
- Completion
- 2012-06-13
- First posted
- 2010-06-22
- Last updated
- 2019-04-25
- Results posted
- 2019-04-25
Locations
6 sites across 5 countries: United States, Czechia, Hungary, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01148810. Inclusion in this directory is not an endorsement.