Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

Phase 3

Completed

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

• Registration Number: NCT00144547
• 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 MRA012JP.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• 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: 241

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
Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)	0W,4W,8W,12W,LOBS
Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria	0W,4W,8W,12W,LOBS

Secondary Outcome Measures

Name	Time	Method
Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set	0W,4W,8W,12W,LOBS
Frequency, severity, and seriousness of adverse events and adverse drug reactions	Throughout study