Trials / Completed
CompletedNCT00335985
Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Japan Blood Products Organization · Industry
- Sex
- All
- Age
- 16 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GB-0998 | 8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days |
| DRUG | Placebo of GB-0998 | 8 mL/kg per day is intravenously administered for five successive days |
Timeline
- Start date
- 2006-06-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2006-06-12
- Last updated
- 2014-11-05
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00335985. Inclusion in this directory is not an endorsement.