Skip to main content
OpenTrials
Completed

NCT Number: NCT00335985

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polymyositis Connective Tissue Diseases Dermatomyositis Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo Medical and Dental University

Bunkyo-ku, Tokyo, 113-8519, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have been defined as "definite" based on the criteria of Bohan and Peter for polymyositis and dermatomyositis.
  • Patients who are defined as steroid-resistant ones based on the changes of scores on manual muscle testing (MMT) and serum levels of creatine kinase (CK) during observation period before administration of drug.

Exclusion criteria

  • Patients with malignant tumors.
  • Patients with acute interstitial pneumonia, including acute exacerbation of chronic.
  • Patients with severe muscular atrophy for a long period.
  • Patients with severe infectious disease.
  • Patients who have the anamnesis of shock or hypersensitivity to this drug.
  • Patients with severe hepatic disorder or severe renal disorder.
  • Patients who have the anamnesis of cerebral infarction or ischemic heart disease, or who having symptom of these diseases.
  • Patients who have been diagnosed as IgA deficiency in their past history.
  • Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant.
  • Patients who were administered immunoglobulin dosage within 6 weeks before consent.

Treatment and study plan

GB-0998

Drug

8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days

Other names: High-dose intravenous immunoglobulin, Venoglobulin-IH

Placebo of GB-0998

Drug

8 mL/kg per day is intravenously administered for five successive days

Primary outcomes

  1. Changes in manual muscle strength (MMT) scores

    Time frame: 8 weeks

Secondary outcomes

  1. Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)

    Time frame: 8 weeks

  2. Adverse events and laboratory tests

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Japan Blood Products Organization

Industry

Registry information

Official study title

A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 12, 2006
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.