Long-Term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP - Full Text View

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144586

Purpose

This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Extension, Phase III Study to Evaluate the Long-Term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA220JP or MRA221JP

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study. [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. [ Time Frame: Week 0, then every 4 Week ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	March 2005
Estimated Study Completion Date:	January 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: MRA(Tocilizumab) 8mg/kg/4 weeks

Eligibility

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

Criteria

Inclusion criteria

RA patients who participated in the previous studies
Patients who completed the last observation in the previous studies
Patients who were confirmed to have no problems with safety in the previous studies.

Exclusion criteria

Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product
Patients who were not enrolled by 3 months after the last observation day of the previous study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144586

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Director:

Yuji Kimura

Chugai Pharmaceutical

More Information

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	MRA222JP
Study First Received:	September 2, 2005
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00144586
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