Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
Information source: Japan Blood Products Organization
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polymyositis; Dermatomyositis
Intervention: GB-0998 (Drug); Placebo of GB-0998 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Japan Blood Products Organization Official(s) and/or principal investigator(s): Nobuyuki Miyasaka, Professor, Study Chair, Affiliation: Tokyo Medical and Dental University
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.
Clinical Details
Official title: A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Changes in manual muscle strength (MMT) scores
Secondary outcome: Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)Adverse events and laboratory tests
Eligibility
Minimum age: 16 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Tokyo Medical and Dental University, Bunkyo-ku, Tokyo 113-8519, Japan
Additional Information
Starting date: June 2006
Last updated: November 3, 2014
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