Overview

Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment

Status:
Completed

Trial end date:
2005-10-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chugai Pharmaceutical

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