An open-label, clinical pharmacology study to investigate Drug-Drug Interaction in patients with RA

Condition	Intervention
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)

Further Study Details: 

Primary Outcomes: Pharmacokinetics:; The pharmacokinetic parameters. changes in the PM group compared with the EM group.; Efficacy:; 20% improvement based on the ACR criteria compared with the baseline value.; Safety:; Adverse events at 0W,1W,2W
Secondary Outcomes: Efficacy:; Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.at 0W,1W,2W
Expected Total Enrollment:  31

Ages Eligible for Study:  20 Years   -   75 Years,  Genders Eligible for Study:  Both

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

Study chairs or principal investigators

Takahiro Kakehi,  Study Director,  Chugai Pharmaceutical Co., Ltd.   

Study ID Numbers:  MRA220JP
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144560
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13