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This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRA(Tocilizumab) | Drug | 8mg/kg/4weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS | every 3 months | |
| Safety:Incidence and severity of adverse events and adverse drug reactions | whole period | |
| Pharmacokinetics:The time course of the trough values for the serum MRA concentration | whole period |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each variable of the JIA core set, CRP, pain every 3M, LOBS | every 3 months |
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Inclusion criteria
Exclusion criteria
Patients who were not enrolled by 3 months after completion of the previous study
Patients who received any of the following since completion of the previous study until initiation of treatment in the present study
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| Name | Affiliation | Role |
|---|---|---|
| Takahiro Kakehi | Chugai Pharmaceutical | Study Director |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| 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 |