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

• Sponsor: Chugai Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00144521
• Collaborator: (none)
• Enrollment: 127
• Arms: 2
• Duration (Months): 26

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: MRA(Tocilizumab); Drug: MRA placebo; Drug: MTX; Drug: MTX placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Aug 1, 2004
• Actual Study Completion Date: Apr 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: MRA(Tocilizumab); 8mg/kg/4week(i.v.)for 24 weeks; Drug: MTX placebo; 0mg/week(p.o.) for 24 weeks
Active Comparator: 2	Drug: MRA placebo; 0mg/kg/4week(i.v.) for 24 weeks; Drug: MTX; 8mg/week(p.o.) for 24 weeks

Outcome Measures

Primary Outcome Measures

1. Frequency of ACR 20% improvement [week 24]

Secondary Outcome Measures

1. Frequency and severity of adverse events and adverse drug reactions [throughout study]

2. Time course of DAS28 [throughout study]

3. time course of the frequency of ACR 20%, 50% and 70% [throughout study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chugai Pharmaceutical

Investigators

• Study Director: Takahiro Kakehi, Chugai Pharmaceutical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00144521
• Other Study ID Numbers: MRA213JP
• First Posted: Sep 5, 2005
• Last Update Posted: Feb 2, 2009
• Last Verified: Jan 1, 2009

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Feb 2, 2009