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

• Sponsor: Chugai Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00144560
• Collaborator: (none)
• Enrollment: 31
• Duration (Months): 5.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Aug 1, 2005
• Actual Study Completion Date: Aug 1, 2005

Outcome Measures

Primary Outcome Measures

1. 20% improvement based on the ACR criteria compared with the baseline value. [throughout study]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chugai Pharmaceutical

Investigators

• Study Director: Takahiro Kakehi, Chugai Pharmaceutical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00144560
• Other Study ID Numbers: MRA220JP
• First Posted: Sep 5, 2005
• Last Update Posted: Dec 15, 2008
• Last Verified: Dec 1, 2008

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Dec 15, 2008