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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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