drugset / Trial / NCT00335985

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

NCT00335985 ↗

Phase 3 Completed 26 enrolled Japan Blood Products Organization
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2006-06
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject GB-0998 Protein / enzyme biologic 400 mg/kg Intravenous

Indications