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

December 11, 2008 updated by: Chugai Pharmaceutical

An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA

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

Study Overview

Status

Completed

Conditions

Rheumatoid Arthritis

Intervention / Treatment

Drug: MRA(Tocilizumab)

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
20% improvement based on the ACR criteria compared with the baseline value. Time Frame: throughout study	throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. Time Frame: Week 0,Week 1, Week 2	Week 0,Week 1, Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria