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

NCT00335985 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-11-05

No results posted yet for this study

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

  • Polymyositis
  • Dermatomyositis

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

Sponsors & Collaborators

  • Japan Blood Products Organization

    lead INDUSTRY

Principal Investigators

  • Nobuyuki Miyasaka, Professor · Tokyo Medical and Dental University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00335985 on ClinicalTrials.gov