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

This study has been completed.
Information provided by (Responsible Party):
Japan Blood Products Organization Identifier:
First received: June 8, 2006
Last updated: November 3, 2014
Last verified: February 2012
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.

Condition Intervention Phase
Drug: GB-0998
Drug: Placebo of GB-0998
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis

Resource links provided by NLM:

Further study details as provided by Japan Blood Products Organization:

Primary Outcome Measures:
  • Changes in manual muscle strength (MMT) scores [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL) [ Time Frame: 8 weeks ]
  • Adverse events and laboratory tests [ Time Frame: 8 weeks ]

Enrollment: 26
Study Start Date: June 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: GB-0998
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 Comparator: 2 Drug: Placebo of GB-0998
8 mL/kg per day is intravenously administered for five successive days


Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00335985

Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519
Sponsors and Collaborators
Japan Blood Products Organization
Study Chair: Nobuyuki Miyasaka, Professor Tokyo Medical and Dental University
  More Information

Responsible Party: Japan Blood Products Organization Identifier: NCT00335985     History of Changes
Other Study ID Numbers: 0998-12
Study First Received: June 8, 2006
Last Updated: November 3, 2014

Keywords provided by Japan Blood Products Organization:
polymyositis, dermatomyositis
High-dose intravenous immunoglobulin
Steroid-resistant polymyositis(PM) and dermatomyositis(DM)

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017