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
Sponsored by: Japan Blood Products Organization
Official(s) and/or principal investigator(s):
Nobuyuki Miyasaka, Professor, Study Chair, Affiliation: Tokyo Medical and Dental University
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.
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
Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)
Adverse events and laboratory tests
Minimum age: 16 Years.
Maximum age: 75 Years.
- 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.
- 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
- 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
Starting date: June 2006
Last updated: November 3, 2014