Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)

Chugai Pharmaceutical

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: MRA(Tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144560

MRA220JP

Details and patient eligibility

About

This is an open-label, clinical pharmacology study to investigate drug-drug interaction in patients with RA.

Enrollment: 31 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 American College of Rheumatology (ACR) classification criteria
• Patients who contracted RA at least 6 months prior

Exclusion criteria

• Patients with Class IV Steinbrocker functional impairment at enrollment.
• 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 initiation of treatment with the probe drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)