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

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144521

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: MRA(Tocilizumab) Drug: MRA placebo Drug: MTX Drug: MTX placebo	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

Frequency of ACR 20% improvement [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency and severity of adverse events and adverse drug reactions [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Time course of DAS28 [ Time Frame: throughout study ] [ Designated as safety issue: No ]
time course of the frequency of ACR 20%, 50% and 70% [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Enrollment:	127
Study Start Date:	February 2004
Study Completion Date:	April 2006
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144521

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Director:

Takahiro Kakehi

Chugai Pharmaceutical

More Information

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	MRA213JP
Study First Received:	September 2, 2005
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00144521
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009