Status:
TERMINATED
Efficacy and Tolerability of BAF312 in Patients With Polymyositis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Polymyositis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
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 s...
Eligibility Criteria
Inclusion
- "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
- 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
Key Trial Info
Start Date :
April 24 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01801917
Start Date
April 24 2013
End Date
August 5 2016
Last Update
January 5 2021
Active Locations (8)
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1
Novartis Investigative Site
Phoenix, Arizona, United States, 85013
2
Novartis Investigative Site
Torono, Ontario, Canada, M5G 2C4
3
Novartis Investigative Site
Prague, Czechia, 128 50
4
Novartis Investigative Site
Budapest, Hungary, 1083