Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Conditions

Systemic Juvenile Idiopathic Arthritis

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

Aoki C, Inaba Y, Choe H, Kaneko U, Hara R, Miyamae T, Imagawa T, Mori M, Oba MS, Yokota S, Saito T.

2014-05-0120 citations

10.3899/jrheum.130924

Longterm Safety and Effectiveness of the Anti-interleukin 6 Receptor Monoclonal Antibody Tocilizumab in Patients with Systemic Juvenile Idiopathic Arthritis in Japan

Shumpei Yokota, Tomoyuki Imagawa, Masaaki Mori, Takako Miyamae, Syuji Takei et al. (12 authors)

The Journal of Rheumatology2014-03-1570 citations

10.3899/jrheum.130690

Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial.

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.

2008-03-01522 citations

10.1016/s0140-6736(08)60454-7

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMRA(Tocilizumab)

8mg/kg/2weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 19 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	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

Secondary

Measure	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

Outcome results

None listed