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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144560
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 15, 2008
Information provided by:
Chugai Pharmaceutical

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) Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : February 2005
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 20% improvement based on the ACR criteria compared with the baseline value. [ Time Frame: 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. [ Time Frame: Week 0,Week 1, Week 2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144560

Sponsors and Collaborators
Chugai Pharmaceutical
Study Director: Takahiro Kakehi Chugai Pharmaceutical

Responsible Party: Chugai Pharmaceutical Identifier: NCT00144560     History of Changes
Other Study ID Numbers: MRA220JP
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: December 15, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases