Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)

Phase 3

Completed

• Conditions: Polymyositis; Dermatomyositis
• Interventions: Drug: GB-0998; Drug: Placebo of GB-0998

• Registration Number: NCT00335985
• Lead Sponsor: Japan Blood Products Organization

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 in manual muscle strength (MMT) scores as primary endpoint, and in addition, to assess the safety of GB-0998.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-08
• Study First Submitted QC: 2006-06-09
• Study First Posted: 2006-06-12
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2012-02
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GB-0998	-
2	Placebo of GB-0998	-

Primary Outcome Measures

Name	Time	Method
Changes in manual muscle strength (MMT) scores	8 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events and laboratory tests	8 weeks
Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)	8 weeks

Trial Locations

Locations (1)

Tokyo Medical and Dental University; 🇯🇵 Bunkyo-ku, Tokyo, Japan