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An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRA(Tocilizumab) | Drug | 8mg/kg/2weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study) | whole period | |
| Safety:Incidence and severity of adverse events and adverse reactions | whole period | |
| Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks | 0 week and every 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks | 0 week and every 2 weeks |
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Inclusion criteria (MRA011JP patients)
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Takahiro Kakehi | Chugai Pharmaceutical | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24786929 | Derived | Aoki C, Inaba Y, Choe H, Kaneko U, Hara R, Miyamae T, Imagawa T, Mori M, Oba MS, Yokota S, Saito T. Discrepancy between clinical and radiological responses to tocilizumab treatment in patients with systemic-onset juvenile idiopathic arthritis. J Rheumatol. 2014 Jun;41(6):1171-7. doi: 10.3899/jrheum.130924. Epub 2014 May 1. | |
| 24634205 |
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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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| Yokota S, Imagawa T, Mori M, Miyamae T, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Longterm safety and effectiveness of the anti-interleukin 6 receptor monoclonal antibody tocilizumab in patients with systemic juvenile idiopathic arthritis in Japan. J Rheumatol. 2014 Apr;41(4):759-67. doi: 10.3899/jrheum.130690. Epub 2014 Mar 15. |
| 18358927 | Derived | Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008 Mar 22;371(9617):998-1006. doi: 10.1016/S0140-6736(08)60454-7. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |