Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
NCT ID: NCT00144599
Last Updated: 2008-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
56 participants
INTERVENTIONAL
2004-05-31
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
MRA(Tocilizumab)
2
placebo
Interventions
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MRA(Tocilizumab)
placebo
Eligibility Criteria
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Inclusion Criteria
* Patients between 2 and 19 years of age
* Patients who are under 16 years of age at onset
* Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions
Exclusion Criteria
* Patients who have received the following treatments within 4 weeks before treatment with the investigational product
1. Surgical treatment (e.g., operation)
2. Plasma exchange therapy"
2 Years
19 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Chugai Pharmaceutical
Principal Investigators
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Takahiro Kakehi
Role: STUDY_DIRECTOR
Chugai Pharmaceutical
References
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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.
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.
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.
Other Identifiers
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MRA316JP
Identifier Type: -
Identifier Source: org_study_id