Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: MRA(Tocilizumab); Drug: MRA placebo; Drug: MTX placebo; Drug: MTX

• Registration Number: NCT00144521
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2004-08
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Study Completion: 2006-04
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-30
• Last Update Posted: 2009-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MRA(Tocilizumab)	-
1	MTX placebo	-
2	MRA placebo	-
2	MTX	-

Primary Outcome Measures

Name	Time	Method
Frequency of ACR 20% improvement	week 24

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events and adverse drug reactions	throughout study
Time course of DAS28	throughout study
time course of the frequency of ACR 20%, 50% and 70%	throughout study