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Clinical Trials/NCT00144612
NCT00144612CompletedPhase 3

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

Chugai Pharmaceutical0 sites60 target enrollmentStarted: July 2004Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
60
Primary Endpoint
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)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

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

1

Experimental

Intervention: MRA(Tocilizumab) (Drug)

Outcomes

Primary Outcomes

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)

Time Frame: whole period

Safety:Incidence and severity of adverse events and adverse reactions

Time Frame: whole period

Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks

Time Frame: 0 week and every 2 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry

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