Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
NCT ID: NCT00144612
Last Updated: 2009-12-23
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
60 participants
INTERVENTIONAL
2004-07-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
MRA(Tocilizumab)
8mg/kg/2weeks
Interventions
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MRA(Tocilizumab)
8mg/kg/2weeks
Eligibility Criteria
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Inclusion Criteria
* the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)
* Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal
* Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period
Exclusion Criteria
* Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study
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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MRA317JP
Identifier Type: -
Identifier Source: org_study_id