Infliximab in Polymyositis / Dermatomyositis / Inclusion Body Myositis
Principal Investigator:
Ingrid Lundberg, Karolinska Institute
Study Design:
Phase 2 Open trial, Infliximab dose 5 mg/kg
Types & Number of IIM Studied:
Active Polymyositis/Dermatomyositis/Inclusion Body Myositis with reduced muscle function (N = 15)
Entry Criteria:
Refractory to prednisolone and methotrexate
IMACS Core Set Measures Included:
Physician and Patient Global Activity and Damage Assessments, Health Assessment Questionnaire, Manual Muscle Testing, muscle enzymes, Myositis Disease Activity Assessment Tool; Myositis Damage Index, Health-Related Quality of Life by SF-36
Other Measures Included:
Myositis Functional Index, aerobic capacity, biopsies
Primary Outcome:
Improved functional index and decreased inflammation in muscle biopsies
Study Duration:
16 weeks
Funding:
Schering Plough
Comments:
Started in 2003. Enrollment completed.
Contact:
- 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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