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Infliximab in Polymyositis and Dermatomyositis

Principal Investigator:

Mark Gourley, NIAMS, NIH

Study Design:

Phase 1-2, randomized, placebo controlled, cross-over trial. Infliximab dose 5-7.5 mg/kg, NIH only

Types & Number of IIM Studied:

Active Polymyositis and Dermatomyositis (N = 12)

Entry Criteria:

Probable or definite Bohan and Peter criteria for polymyositis or dermatomyositis, Refractory to methotrexate, azathioprine, or another immunosuppressive agent, as well as steroids

IMACS Core Set Measures Included:

All: Physician and Patient Global Activity Assessments, Manual Muscle Testing, enzymes, Health Assessment Questionnaire, Myositis Disease Activity Assessment Tool; Myositis Damage Index, Health-Related Quality of Life by SF-36

Other Measures Included:

Magnetic resonance imaging, flow cytometry, microarrays, cytokine levels/genes, MHC typing

Primary Outcome:

IMACS Definitions of Improvement and 15% increase of Manual Muscle Testing alone

Study Duration:

16 weeks treatment, placebo crossover to treatment for 16 weeks more with total duration 70 weeks

Funding:

NIAMS, NIH; Centocor

Comments:

Enrollment Completed

Publications:

Dastmalchi M1, Grundtman C, Alexanderson H, Mavragani CP, Einarsdottir H, Helmers SB, Elvin K, Crow MK, Nennesmo I, Lundberg I. A high incidence of disease flares in an open pilot study of infliximab in patients with refractory inflammatory myopathies., Ann Rheum Dis, 2008 Dec;67(12):1670-7.[Abstract ]

Contact:

Mark Gourley, M.D.
Tel (301) 451-6807
Fax (301) 451-5590
gourleym@mail.nih.gov
Paul Plotz, M.D.
Tel (301) 496-1474
plotzp@mail.nih.gov

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