Trial record 4 of 48 for:
Polymyositis
Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
This study has been completed.
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Collaborator:
Benesis Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00335985
First received: June 8, 2006
Last updated: February 21, 2012
Last verified: February 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis |
Resource links provided by NLM:
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 ]
| Enrollment: | 26 |
| Study Start Date: | June 2006 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: GB-0998
8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days
Other Names:
|
| Placebo Comparator: 2 |
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 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
No publications provided
| Responsible Party: | Mitsubishi Tanabe Pharma Corporation |
| ClinicalTrials.gov Identifier: | NCT00335985 History of Changes |
| Other Study ID Numbers: | 0998-12 |
| Study First Received: | June 8, 2006 |
| Last Updated: | February 21, 2012 |
| 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) |
Additional relevant MeSH terms:
|
Polymyositis Dermatomyositis Myositis Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Connective Tissue Diseases |
Skin Diseases Immunoglobulins Antibodies Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013