Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)

This study has been completed.

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144560

Purpose

This is an open-label, clinical pharmacology study to investigate drug-drug interaction in patients with RA.

Condition	Intervention
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)

MedlinePlus related topics: Rheumatoid Arthritis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

20% improvement based on the ACR criteria compared with the baseline value. [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. [ Time Frame: Week 0,Week 1, Week 2 ] [ Designated as safety issue: No ]

Enrollment:	31
Study Start Date:	February 2005
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion criteria

Patients who are diagnosed with RA according to the 1987 American College of Rheumatology (ACR) classification criteria
Patients who contracted RA at least 6 months prior

Exclusion criteria

Patients with Class IV Steinbrocker functional impairment at enrollment.
Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept and have been receiving treatment with leflunomide, within 12 weeks before initiation of treatment with the probe drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144560

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Director:

Takahiro Kakehi

Chugai Pharmaceutical

More Information

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	MRA220JP
Study First Received:	September 2, 2005
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00144560
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