Efficacy and Safety Study of GB-0998 for Treatment of Steroid-Resistant Polymyositis and Dermatomyositis (PM/DM) - Full Text View

Sponsors and Collaborators:	Mitsubishi Tanabe Pharma Corporation Benesis Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00335985

Purpose

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.

Condition	Intervention	Phase
Polymyositis Dermatomyositis	Drug: GB-0998 Drug: Placebo of GB-0998	Phase III

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Controlled Clinical Study of GB-0998 for the Steroid-Resistant Polymyositis and Dermatomyositis

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

Changes in manual muscle strength (MMT) scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Adverse events and laboratory tests [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	June 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: GB-0998 8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days
2: Placebo Comparator	Drug: Placebo of GB-0998 8 mL/kg per day is intravenously administered for five successive days

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335985

Locations

Japan, Tokyo
Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Benesis Corporation

Investigators

Study Chair:

Nobuyuki Miyasaka, Professor

Tokyo Medical and Dental University

More Information

Responsible Party:	Mitsubishi Tanabe Pharma Corporation ( General Manager, Clinical Research Department I )
Study ID Numbers:	0998-12
Study First Received:	June 8, 2006
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00335985
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

polymyositis, dermatomyositis
High-dose intravenous immunoglobulin
Venoglobulin-IH
Steroid-resistant polymyositis(PM) and dermatomyositis(DM)

Study placed in the following topic categories:

Skin Diseases
Myositis
Dermatomyositis
Antibodies
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases

Immunoglobulins, Intravenous
Polymyositis
Connective Tissue Diseases
Idiopathic myopathy
Rho(D) Immune Globulin
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009