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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB-0998 | Drug | 8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in manual muscle strength (MMT) scores | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL) | 8 weeks | |
| Adverse events and laboratory tests | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nobuyuki Miyasaka, Professor | Tokyo Medical and Dental University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Medical and Dental University | Bunkyo-ku | Tokyo | 113-8519 | Japan |
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| ID | Term |
|---|---|
| D017285 | Polymyositis |
| D003882 | Dermatomyositis |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo of GB-0998 | Drug | 8 mL/kg per day is intravenously administered for five successive days |
|
| D009422 |
| Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |