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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: MRA(Tocilizumab)
* Drug: MRA placebo
* Drug: MTX
* Drug: MTX placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR) Disease duration of 6 months or more Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 1.0 mg/dL Exclusion criteria Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug. Administration of any DMARD or immunosuppressant other than MTX Administration of corticosteroids exceeding 10 mg/day as prednisolone Dose escalation or initiation of corticosteroids Received any of the following therapies in the 4 weeks preceding treatment with the study drug Plasma exchange therapy Surgical treatment (operation, etc.)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MRA(Tocilizumab)<br>* 8mg/kg/4week(i.v.)for 24 weeks<br>Drug: MTX placebo<br>* 0mg/week(p.o.) for 24 weeks<br>|
| Active Comparator: 2<br> | Drug: MRA placebo<br>* 0mg/kg/4week(i.v.) for 24 weeks<br>Drug: MTX<br>* 8mg/week(p.o.) for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of ACR 20% improvement |  | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |