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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00335985
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
Japan Blood Products Organization

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Polymyositis Dermatomyositis Drug: GB-0998 Drug: Placebo of GB-0998 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : June 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335985


Locations
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Japan
Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519
Sponsors and Collaborators
Japan Blood Products Organization
Investigators
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Study Chair: Nobuyuki Miyasaka, Professor Tokyo Medical and Dental University
More Information
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Responsible Party: Japan Blood Products Organization
ClinicalTrials.gov Identifier: NCT00335985    
Other Study ID Numbers: 0998-12
First Posted: June 12, 2006    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: February 2012
Keywords provided by Japan Blood Products Organization:
polymyositis, dermatomyositis
High-dose intravenous immunoglobulin
Venoglobulin-IH
Steroid-resistant polymyositis(PM) and dermatomyositis(DM)
Additional relevant MeSH terms:
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Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
 Skin Diseases
Immunoglobulins
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs