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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT01165008
Date of registration: 16/07/2010
Prospective Registration: No
Primary sponsor: Karolinska Institutet
Public title: Anakinra in Myositis
Scientific title: Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies
Date of first enrolment: September 2003
Target sample size:
Recruitment status: Completed
Study type:  Interventional
Study design:  Intervention Model: Single Group Assignment, Primary Purpose: Treatment  
Phase:  Phase 2/Phase 3
Countries of recruitment
Key inclusion & exclusion criteria

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.


Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Inclusion Body Myositis
Drug: Anakinra
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
KS 01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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