Status:
COMPLETED
Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
Lead Sponsor:
Japan Blood Products Organization
Conditions:
Polymyositis
Dermatomyositis
Eligibility:
All Genders
16-75 years
Phase:
PHASE3
Brief Summary
This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based on the changes...
Eligibility Criteria
Inclusion
- Patients who have been defined as "definite" based on the criteria of Bohan and Peter for polymyositis and dermatomyositis.
- Patients who are defined as steroid-resistant ones based on the changes of scores on manual muscle testing (MMT) and serum levels of creatine kinase (CK) during observation period before administration of drug.
Exclusion
- Patients with malignant tumors.
- Patients with acute interstitial pneumonia, including acute exacerbation of chronic.
- Patients with severe muscular atrophy for a long period.
- Patients with severe infectious disease.
- Patients who have the anamnesis of shock or hypersensitivity to this drug.
- Patients with severe hepatic disorder or severe renal disorder.
- Patients who have the anamnesis of cerebral infarction or ischemic heart disease, or who having symptom of these diseases.
- Patients who have been diagnosed as IgA deficiency in their past history.
- Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant.
- Patients who were administered immunoglobulin dosage within 6 weeks before consent.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00335985
Start Date
June 1 2006
End Date
March 1 2009
Last Update
November 5 2014
Active Locations (1)
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1
Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519