NCT00335985View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
PolymyositisDermatomyositis
Interventions
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

Trial Locations (1)

113-8519

Tokyo Medical and Dental University, Bunkyo-ku

Sponsors
All Listed Sponsors
lead

Japan Blood Products Organization

INDUSTRY