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:
Started in the Czech Republic, approval obtained in Slovak Republic
a Slovenia. Institutional Review Board approval in Sweden.
Contact:
Jiri Vencovsky, Institute of Rheumatology, Na Slupi 4, 12850 Praha
2, Czech Republic, E-mail: venc@revma.cz, Telephone: +420234075111,
Fax: +420224914451
Ingrid Lundberg, Rheumatology Unit, Department of
Medicine, Karolinska University Hospital, Solna, Karolinska Institutet,
SE- 171 76 Stockholm, Sweden, Phone: +46-8- 5177 6087, Fax: +46-8-
5177 3080, Email: Ingrid.Lundberg@medks.ki.se
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