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Anakinra in Myositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01165008
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : July 19, 2010
Information provided by:
Karolinska Institutet

Brief Summary:

To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies.

Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per day during 12 months. Outcome measures included myositis disease activity score with improvement defined according to The International Myositis Assessment and Clinical Studies Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition repeat muscle biopsies were performed

Condition or disease Intervention/treatment Phase
Polymyositis Dermatomyositis Inclusion Body Myositis Drug: Anakinra Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies
Study Start Date : September 2003
Actual Study Completion Date : September 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Men and women aged 18 to 80 years with diagnosis of PM, DM or IBM based Peter and Bohan's and Grigg's criteria. All patients had to be capable of giving informed consent. Other inclusion criteria were muscle strength and/or function reduced at least 20 % below predicted values as measured by functional index (FI) [45-47] and failure to respond to treatment with high-dose glucocorticoids (0.75 mg/kg/day for at least one month) in combination with azathioprine and/or methotrexate for at least two months.


Exclusion Criteria:

serious infections such as hepatitis, pneumonia, pyelonephritis in the previous 3 months; history of opportunistic infections such as tuberculosis, drug resistant atypical mycobacterium, active pneumocystis carinii, active cytomegalovirus infection; documented HIV infection; alcoholism, alcoholic liver disease or other chronic liver disease; chest x-ray suggestive of active tuberculosis; and pregnant, nursing mothers or patients with planned pregnancy within one and a half years of enrolment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01165008

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Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet

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Responsible Party: Ingrid Lundberg, Karolinska University Hospital Identifier: NCT01165008     History of Changes
Other Study ID Numbers: KS 01
03-144 ( Other Identifier: Etikprovningsnamnden i Stockholm )
First Posted: July 19, 2010    Key Record Dates
Last Update Posted: July 19, 2010
Last Verified: February 2005

Additional relevant MeSH terms:
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Myositis, Inclusion Body
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents