Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
Study Details
Study Description
Brief Summary
This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- 20% improvement based on the ACR criteria compared with the baseline value. [throughout study]
Secondary Outcome Measures
- Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. [Week 0, Week 4]
Eligibility Criteria
Criteria
Inclusion criteria
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Patients who are diagnosed with RA according to the 1987 ACR (American College of Rheumatology) classification criteria
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Patients with RA at least 6 months prior to enrollment
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Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min
Exclusion criteria
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Patients with Class IV Steinbrocker functional impairment at enrollment
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Patients who are undergoing dialysis
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chugai Pharmaceutical
Investigators
- Study Director: Takahiro Kakehi, Chugai Pharmaceutical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MRA221JP