Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Conditions

Systemic Juvenile Idiopathic Arthritis

Brief summary

This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.

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

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

Interventions

DRUGMRA(Tocilizumab)

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 19 Years

Healthy volunteers

No

Inclusion criteria

* Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997) * 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 been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product * 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

Design outcomes

Primary

Measure	Time frame
Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS	open-label period
Efficacy:Percentage of patients in whom effects were maintained	Blind period
Safety:Incidence and severity of adverse events and adverse drug reactions	whole period
Pharmacokinetics:The time course of the trough serum MRA concentration	whole period

Secondary

Measure	Time frame
Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score	Open-label period
Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS	Blind Period

Outcome results

None listed