Long-Term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP - Full Text View

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144547

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 MRA012JP.

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 MRA012JP

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP) [ Time Frame: 0W,4W,8W,12W,LOBS ] [ Designated as safety issue: No ]
Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria [ Time Frame: 0W,4W,8W,12W,LOBS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set [ Time Frame: 0W,4W,8W,12W,LOBS ] [ Designated as safety issue: No ]
Frequency, severity, and seriousness of adverse events and adverse drug reactions [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment:	241
Study Start Date:	April 2004
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Patients must suffer from RA, and must have participated in the preceding study.
Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.

Exclusion criteria

Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
Patients who have not been registered by 3 months after week 52 of the preceding study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144547

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Director:

Takahiro Kakehi

Chugai Pharmaceutical

More Information

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	MRA214JP
Study First Received:	September 2, 2005
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00144547
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