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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 MRA213JP.
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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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria | throughout study | |
| Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions | throughout study | |
| Pharmacokinetics of the serum MRA concentration | 0W,4W,8W,12W,LOBS |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: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 |
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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 |