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

This study has been completed.

Sponsor:

Information provided by:

Chugai Pharmaceutical

ClinicalTrials.gov Identifier:

NCT00144560

First received: September 2, 2005

Last updated: December 11, 2008

Last verified: December 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

December 11, 2008

Start Date ^ICMJE

February 2005

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

20% improvement based on the ACR criteria compared with the baseline value. [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

20% improvement based on the ACR criteria compared with the baseline value.
Pharmacokinetics:
The pharmacokinetic parameters. changes in the PM group compared with the EM group.
Efficacy:
Safety:
Adverse events at 0W,1W,2W

Change History

Complete list of historical versions of study NCT00144560 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy:
Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.at 0W,1W,2W

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: MRA(Tocilizumab)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2005

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00144560

Other Study ID Numbers ^ICMJE

MRA220JP

Has Data Monitoring Committee

Not Provided

Responsible Party

Chugai Pharmaceutical

Study Sponsor ^ICMJE

Chugai Pharmaceutical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Takahiro Kakehi

Chugai Pharmaceutical

Information Provided By

Chugai Pharmaceutical

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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