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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144521
• Other study ID #: MRA213JP
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: January 30, 2009
• Start date: February 2004
• Est. completion date: April 2006

Study information

• Verified date: January 2009
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: April 2006
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• MRA(Tocilizumab)
8mg/kg/4week(i.v.)for 24 weeks
• MRA placebo
0mg/kg/4week(i.v.) for 24 weeks
• MTX
8mg/week(p.o.) for 24 weeks
• MTX placebo
0mg/week(p.o.) for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of ACR 20% improvement		week 24	No
Secondary	Frequency and severity of adverse events and adverse drug reactions		throughout study	Yes
Secondary	Time course of DAS28		throughout study	No
Secondary	time course of the frequency of ACR 20%, 50% and 70%		throughout study	No