Status:
COMPLETED
Anakinra in Myositis
Lead Sponsor:
Karolinska Institutet
Conditions:
Polymyositis
Dermatomyositis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 po...
Eligibility Criteria
Inclusion
- 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.
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Exclusion
- 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.
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Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01165008
Start Date
September 1 2003
End Date
September 1 2008
Last Update
July 19 2010
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden, 17176