Anakinra in Myositis

Phase 2

Completed

• Conditions: Polymyositis; Dermatomyositis; Inclusion Body Myositis

• Registration Number: NCT01165008
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Status Verified: 2005-02
• Study Completion: 2008-09
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-16
• Last Update Submitted: 2010-07-16
• Study First Posted: 2010-07-19
• Last Update Posted: 2010-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden