Status:
TERMINATED
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Polymyositis
Dermatomyositis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 immu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Other idiopathic inflammatory myopathies
- Myopathy other than polymyositis and dermatomyositis
- Patients with late stages of disease
Key Trial Info
Start Date :
June 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01148810
Start Date
June 15 2010
End Date
June 13 2012
Last Update
April 25 2019
Active Locations (6)
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1
Novartis Investigative Site
Boston, Massachusetts, United States, 02115
2
Novartis Investigative Site
Prague, Czechia, 128 50
3
Novartis Investigative Site
Budapest, Hungary, 1083
4
Novartis Investigative Site
Debrecen, Hungary, 4032