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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

Tracking Information
First Submitted Date  ICMJE June 8, 2006
First Posted Date  ICMJE June 12, 2006
Last Update Posted Date November 5, 2014
Study Start Date  ICMJE June 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2007)
Changes in manual muscle strength (MMT) scores [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
Changes in manual muscle strength (MMT) scores at 8 weeks.
Change History Complete list of historical versions of study NCT00335985 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
  • Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL) at 8 weeks.
  • Adverse events and laboratory tests.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
Official Title  ICMJE A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Polymyositis
  • Dermatomyositis
Intervention  ICMJE
  • 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
  • Drug: Placebo of GB-0998
    8 mL/kg per day is intravenously administered for five successive days
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: GB-0998
  • Placebo Comparator: 2
    Intervention: Drug: Placebo of GB-0998
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2012)
26
Original Enrollment  ICMJE
 (submitted: June 9, 2006)
20
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00335985
Other Study ID Numbers  ICMJE 0998-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Japan Blood Products Organization
Study Sponsor  ICMJE Japan Blood Products Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nobuyuki Miyasaka, Professor Tokyo Medical and Dental University
PRS Account Japan Blood Products Organization
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP