Clinical trial NCT00144599: Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
Official title: A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA
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: 56
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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"

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