Clinical trial NCT00144612: Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
Official title: An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Juvenile Idiopathic Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion criteria (MRA011JP patients)

* Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period
* 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 were not enrolled by 3 months after completion of the previous study
* Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study

Primary outcomes:
measure: 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)
timeFrame: whole period
measure: Safety:Incidence and severity of adverse events and adverse reactions
timeFrame: whole period
measure: Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks
timeFrame: 0 week and every 2 weeks
Secondary outcomes:
measure: 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
timeFrame: 0 week and every 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Takahiro Kakehi
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.