NCT00144599CompletedPhase 3
A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Chugai Pharmaceutical
- Enrollment
- 56
- Primary Endpoint
- Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS
Study Overview
Brief Summary
This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
2
Placebo Comparator
Intervention: placebo (Drug)
1
Experimental
Intervention: MRA(Tocilizumab) (Drug)
Outcomes
Primary Outcomes
Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS
Time Frame: open-label period
Efficacy:Percentage of patients in whom effects were maintained
Time Frame: Blind period
Safety:Incidence and severity of adverse events and adverse drug reactions
Time Frame: whole period
Pharmacokinetics:The time course of the trough serum MRA concentration
Time Frame: whole period
Secondary Outcomes
- 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)
Investigators
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