Efficacy and Tolerability of BAF312 in Patients With Polymyositis
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Polymyositis
In brief
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).
Key facts
- Study ID
- NCT01801917
- Run by
- Novartis Pharmaceuticals
- People needed
- 14
- Starts
- 2013-04-24
- Expected to finish
- 2016-08-05
- Last updated by the study team
- 2021-01-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- "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.
You may not qualify if…
- 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
Where it is running
- Novartis Investigative Site — Phoenix, Arizona, United States
- Novartis Investigative Site — Torono, Ontario, Canada
- Novartis Investigative Site — Prague, Czechia
- Novartis Investigative Site — Budapest, Hungary
- Novartis Investigative Site — Debrecen, Hungary
- Novartis Investigative Site — Bydgoszcz, Poland
- Novartis Investigative Site — Taichung, Taiwan
- Novartis Investigative Site — Taichung, Taiwan
Full record on ClinicalTrials.gov
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