Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatom… (NCT00335985) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
Japan26 participantsStarted 2006-06
Plain-language 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 in manual muscle strength (MMT) scores as primary endpoint, and in addition, to assess the safety of GB-0998.
Who can participate
Age range16 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.