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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

Page last updated: August 23, 2015

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