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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01165008 |
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Date of registration:
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16/07/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Anakinra in Myositis
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Scientific title:
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Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies |
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Date of first enrolment:
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September 2003 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01165008 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Sweden
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Key inclusion & exclusion criteria
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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.
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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.
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Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Inclusion Body Myositis
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Polymyositis
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Dermatomyositis
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Intervention(s)
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Drug: Anakinra
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Secondary ID(s)
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KS 01
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03-144
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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