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

NCT ID: NCT00144521

Last Updated: 2009-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-04-30

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

MRA(Tocilizumab)

Intervention Type: DRUG

8mg/kg/4week(i.v.)for 24 weeks

MTX placebo

Intervention Type: DRUG

0mg/week(p.o.) for 24 weeks

2

Group Type: ACTIVE_COMPARATOR

MRA placebo

Intervention Type: DRUG

0mg/kg/4week(i.v.) for 24 weeks

MTX

Intervention Type: DRUG

8mg/week(p.o.) for 24 weeks

Interventions

MRA(Tocilizumab)

8mg/kg/4week(i.v.)for 24 weeks

Intervention Type: DRUG

MRA placebo

0mg/kg/4week(i.v.) for 24 weeks

Intervention Type: DRUG

MTX

8mg/week(p.o.) for 24 weeks

Intervention Type: DRUG

MTX placebo

0mg/week(p.o.) for 24 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

1. Administration of any DMARD or immunosuppressant other than MTX

2. Administration of corticosteroids exceeding 10 mg/day as prednisolone

3. Dose escalation or initiation of corticosteroids

• Received any of the following therapies in the 4 weeks preceding treatment with the study drug

1. Plasma exchange therapy

2. Surgical treatment (operation, etc.)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chugai Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Chugai Pharmaceutical

Principal Investigators

Takahiro Kakehi

Role: STUDY_DIRECTOR

Chugai Pharmaceutical

Other Identifiers

MRA213JP

Identifier Type: -

Identifier Source: org_study_id