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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144560
• Other study ID #: MRA220JP
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: December 11, 2008
• Start date: February 2005
• Est. completion date: August 2005

Study information

• Verified date: December 2008
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• MRA(Tocilizumab)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20% improvement based on the ACR criteria compared with the baseline value.		throughout study	No
Secondary	Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.		Week 0,Week 1, Week 2	No