An open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment

Condition	Intervention
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)

Further Study Details: 

Primary Outcomes: Pharmacokinetics:; The serum MRA concentration and pharmacokinetic parameters; Efficacy:; 20% improvement based on the ACR criteria compared with the baseline value.; Safety:; Incidence and severity of adverse events and adverse drug reactions at 0W,4W
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,4W
Expected Total Enrollment:  10

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 ACR (American College of Rheumatology) classification criteria
• Patients with RA at least 6 months prior to enrollment
• Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min

Exclusion criteria

• Patients with Class IV Steinbrocker functional impairment at enrollment
• Patients who are undergoing dialysis
• 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 treatment with the investigational product

Study chairs or principal investigators

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

Study ID Numbers:  MRA221JP
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144573
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13