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
  Purpose

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


Condition Intervention
Rheumatoid Arthritis
Drug: MRA(Tocilizumab)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: February 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144560

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

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144560     History of Changes
Other Study ID Numbers: MRA220JP
Study First Received: September 2, 2005
Last Updated: December 11, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on August 28, 2014