Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis

Phase 3

Completed

• Conditions: Steroid-resistant Polymyositis and Dermatomyositis

• Registration Number: JPRN-jRCT2080220256
• Lead Sponsor: Japan Blood Products Organization

Brief Summary

We randomly assigned 26 subjects (16 PM and 10 DM) to receive either GB-0998 or placebo. Intragroup comparison in the GB-0998 group showed statistically significant improvements due to GB-0998 administration in the primary endpoint (manual muscle test score) and secondary endpoints (serum creatine kinase level and activities of daily living score).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-12
• Study Completion: 2009-03-06
• Last Update Posted: 17 October 2023

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Changes in manual muscle strength (MMT) scores

Secondary Outcome Measures

Name	Time	Method
efficacy<br>Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)