Long-Term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP - Full Text View

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144534

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 MRA213JP.

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 MRA213JP

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Pharmacokinetics of the serum MRA concentration [ Time Frame: 0W,4W,8W,12W,LOBS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy: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 ]

Enrollment:	115
Study Start Date:	June 2004
Primary Completion Date:	August 2005 (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

Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.

Exclusion criteria

Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
Have not been registered by 3 months after the full code-breaking of the preceding study
Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144534

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Director:

Takahiro Kakehi

Chugai Pharmaceutical

More Information

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	MRA215JP
Study First Received:	September 2, 2005
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00144534
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