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This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA012JP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRA(Tocilizumab) | Drug | 8mg/kg(i.v.)/4weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP) | 0W,4W,8W,12W,LOBS | |
| Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria | 0W,4W,8W,12W,LOBS |
| Measure | Description | Time Frame |
|---|---|---|
| Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set | 0W,4W,8W,12W,LOBS | |
| Frequency, severity, and seriousness of adverse events and adverse drug reactions | Throughout study |
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Inclusion criteria
Exclusion criteria
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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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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |