Methotrexate in Polymyositis and Dermatomyositis
Principal Investigator:
Jiri Vencovsky, Prague, Ingrid Lundberg, Stockholm
Study Design:
Phase 3, randomized, placebo controlled, multicenter, Europe
Types & Number of IIM Studied:
Active, early polymyositis and dermatomyositis (N = 100)
Entry Criteria:
Probable or definite Bohan and Peter criteria for polymyositis and dermatomyositis
IMACS Core Set Measures Included:
All - Physician and Patient Global Activity and Damage Assessments, 2 enzymes, Manual Muscle Testing, Health Assessment Questionnaire, Myositis Disease Activity Assessment Tool, Myositis Damage Index, Health-Related Quality of Life by SF-36
Other Measures Included:
IMACS Definitions of Improvement, muscle magnetic resonance imaging, muscle endurance (Myositis Functional Index)
Primary Outcome:
Cumulative dose of prednisone
Study Duration:
12 months
Funding:
Initiation support from Wyeth-Lederle. Grant support from European League Against Rheumatism (EULAR)
Comments:
Actively Enrolling
Contact:
- Jiri Vencovsky
-
Institute of Rheumatology
Na Slupi 4
12850 Praha 2
Czech Republic
Tel +42-02-3407-5111
Fax +42-02-2491-4451
venc@revma.cz
- Ingrid Lundberg, M.D., Ph.D.
-
Rheumatology Unit
Department of Medicine
Karolinska University Hospital
SE- 171 76 Stockholm, Sweden
Tel +46-8-5177-6087
Fax +46-8-5177-3080
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