Clinical Trial: Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis
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 Summary:
Sponsor: Japan Blood Products Organization
Current Primary Outcome: Changes in manual muscle strength (MMT) scores [ Time Frame: 8 weeks ]
Original Primary Outcome: Changes in manual muscle strength (MMT) scores at 8 weeks.
Current Secondary Outcome:
- Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL) [ Time Frame: 8 weeks ]
- Adverse events and laboratory tests [ Time Frame: 8 weeks ]
Original Secondary Outcome:
- Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL) at 8 weeks.
- Adverse events and laboratory tests.
Information By: Japan Blood Products Organization
Dates:
Date Received: June 8, 2006
Date Started: June 2006
Date Completion:
Last Updated: November 3, 2014
Last Verified: February 2012
