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

Dermatomyositis Clinical Trial

Official title:

A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335985
• Other study ID #: 0998-12
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2006
• Last updated: November 3, 2014
• Start date: June 2006
• Est. completion date: March 2009

Study information

• Verified date: February 2012
• Source: Japan Blood Products Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatomyositis
• Polymyositis

Intervention

Drug:
• GB-0998
8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days
• Placebo of GB-0998
8 mL/kg per day is intravenously administered for five successive days

Locations

Country	Name	City	State
Japan	Tokyo Medical and Dental University	Bunkyo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Japan Blood Products Organization

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in manual muscle strength (MMT) scores		8 weeks	No
Secondary	Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)		8 weeks	No
Secondary	Adverse events and laboratory tests		8 weeks	Yes