Trials / Terminated
TerminatedNCT01801917
Efficacy and Tolerability of BAF312 in Patients With Polymyositis
A Multi-centre Double-blind, Placebo Controlled, Proof of Concept Study to Evaluate the Efficacy and Tolerability of BAF312 in Patients With Polymyositis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This study was stopped prematurely due to overall slow recruitment and no evidence for efficacy in a parallel study in dermatomyositis with an assumed similar pathophysiology. With very small sample sizes per group the overall results for this study including primary and all other efficacy and PD data are inconclusive
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Matching placebo tablet for oral administration |
| DRUG | BAF312 | BAF312 in 4 dosage strengths in tablet form: 0.25 mg, 0.5 mg, 1 mg, 2 mg for oral administration |
Timeline
- Start date
- 2013-04-24
- Primary completion
- 2016-08-05
- Completion
- 2016-08-05
- First posted
- 2013-03-01
- Last updated
- 2021-01-05
- Results posted
- 2018-01-04
Locations
8 sites across 6 countries: United States, Canada, Czechia, Hungary, Poland, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01801917. Inclusion in this directory is not an endorsement.