Status:
COMPLETED
Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-75 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00144573
Start Date
January 1 2005
End Date
October 1 2005
Last Update
December 15 2008
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