Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Phase 3

Completed

• Conditions: Polyarticular Juvenile Idiopathic Arthritis
• Interventions: Drug: MRA(Tocilizumab)

• Registration Number: NCT00144625
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-07
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Study Completion: 2009-06
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-21
• Last Update Posted: 2009-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MRA(Tocilizumab)	-

Primary Outcome Measures

Name	Time	Method
Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS	every 3 months
Safety:Incidence and severity of adverse events and adverse drug reactions	whole period
Pharmacokinetics:The time course of the trough values for the serum MRA concentration	whole period

Secondary Outcome Measures

Name	Time	Method
Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each variable of the JIA core set, CRP, pain every 3M, LOBS	every 3 months