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

This study has been completed.
Sponsor:
Collaborator:
Benesis Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00335985
First received: June 8, 2006
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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
Polymyositis
Dermatomyositis
Drug: GB-0998
Drug: Placebo of GB-0998
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Changes in manual muscle strength (MMT) scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Adverse events and laboratory tests [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335985

Locations
Japan
Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Benesis Corporation
Investigators
Study Chair: Nobuyuki Miyasaka, Professor Tokyo Medical and Dental University
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00335985     History of Changes
Other Study ID Numbers: 0998-12
Study First Received: June 8, 2006
Last Updated: February 21, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
polymyositis, dermatomyositis
High-dose intravenous immunoglobulin
Venoglobulin-IH
Steroid-resistant polymyositis(PM) and dermatomyositis(DM)

Additional relevant MeSH terms:
Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014