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

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ClinicalTrials.gov Identifier: NCT00144560
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 15, 2008
Sponsor:
Information provided by:

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
Rheumatoid Arthritis Drug: MRA(Tocilizumab)

Study Design

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
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00144560


Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Takahiro Kakehi Chugai Pharmaceutical
More Information

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov 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
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases