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Your Environment. Your Health.

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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