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This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRA(Tocilizumab) | Drug | 8mg/kg/4 weeks for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| ACR 20% responder rate compared to the pre-treatment in the preceding study | throughout study | |
| Frequency and severity of adverse events and adverse drug reactions | week0,week4,week8,week12,and LOBS |
| Measure | Description | Time Frame |
|---|---|---|
| Time course of DAS28,compared to the pre-treatment in the preceding study | week 0,week 4,week 8,week 12, LOBS | |
| Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study | week 0,week 4,week 8,week 12, LOBS |
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Inclusion Criteria:
Exclusion Criteria:
Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
Patients who received any of the following treatments between the start of preceding study and the registration of this study.
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| Name | Affiliation | Role |
|---|---|---|
| Takahiro Kakehi | Chugai Pharmaceutical | Study Director |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| ACR N AUC compared to the pre-treatment in the preceding study | week 0,week 4,week 8,week 12, LOBS |
| Time course of the ACR core set variables compared to the pre-treatment in the preceding study | week 0,week 4,week 8,week 12, LOBS |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |