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Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144586
First received: September 2, 2005
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: MRA(Tocilizumab)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA220JP or MRA221JP

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • 20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study. [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. [ Time Frame: Week 0, then every 4 Week ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: March 2005
Study Completion Date: June 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MRA(Tocilizumab)
8mg/kg/4 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • RA patients who participated in the previous studies
  • Patients who completed the last observation in the previous studies
  • Patients who were confirmed to have no problems with safety in the previous studies.

Exclusion criteria

  • Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product
  • Patients who were not enrolled by 3 months after the last observation day of the previous study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144586

Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Yuji Kimura Chugai Pharmaceutical
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144586     History of Changes
Other Study ID Numbers: MRA222JP
Study First Received: September 2, 2005
Last Updated: December 21, 2009
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 May 23, 2013