Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: MRA(Tocilizumab)

• Registration Number: NCT00144586
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2008-08
• Study Completion: 2009-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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
20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.	throughout study

Secondary Outcome Measures

Name	Time	Method
Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.	Week 0, then every 4 Week