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

Chugai Pharmaceutical

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: MRA(Tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144573

MRA221JP

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)