Treatment with Interleukin-1 Receptor Antagonist (IL-1ra) in Patients with Chronic Inflammatory Myopathies
Principal Investigator:
Ingrid E. Lundberg
Study Design:
Open label
Types & Number of IIM Studied:
Polymyositis, dermatomyositis and inclusion body myositis in adult
patients
Entry Criteria:
Treatment resistant myositis: (1) Men/women age: 18- 80 years (2) Diagnosis
of polymyositis, dermatomyositis or inclusion body myositis based on
clinical, biochemical, histopathological and electrophysiological criteria
of Bohan & Peter (3) Adequate immunosuppressive treatment for at least 2 months
including corticosteroids > 0,75mg/kg (for at least one month) and treatment with azathioprine
or methotrexate (4) Muscle strength and/or function reduced at least
20 % below predicted values (5) The patients must be capable of giving
informed consent and consent must have been obtained prior to any screening
procedures
IMACS Core Set Measures Included:
Myositis Functional index
Other Measures Included:
(1) Disease activity by the IMACS score: a) Patients global assessment
on an visual analogue scale b) Physicians global assessment on an visual
analogue scale c) Function in daily activities by the Health assessment
questionnaire (HAQ) d) Serum levels of creatine phosphokinase e) Extramuscular
disease activity by Myositis Disease Activity Assessment Tool (MYOACT, MYOVAS) f) Muscle strength by the Manual
Muscle Test (MMT-8) (2) Tolerability to anakinra (3) Function in daily
activities by the myositis specific questionnaire: Myositis activity
profile (MAP) (4) Health related quality of life by the self administrated
questionnaire SF-36
Primary Outcome:
Improvement assessed by the Myositis Functional index (Josefsson et
al) 1996) at 12 months.
Study Duration:
Ongoing
Funding:
Swedish Research Council, Swedish Rheumatism Association
Comments:
None.
Contact:
Ingrid Lundberg, M.D., Ph.D., Rheumatology Unit, Department of Medicine,
Karolinska University Hospital, Solna, Karolinska Institutet, SE- 171
76 Stockholm, Phone: +46-8- 5177 6087, Fax. +46-8- 5177 3080, Email:
Ingrid.Lundberg@medks.ki.se
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