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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:
ClinicalTrials.gov Identifier:
NCT00144586
First Posted: September 5, 2005
Last Update Posted: August 9, 2013
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.
Information provided by (Responsible Party):
Chugai Pharmaceutical
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00144586


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

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144586     History of Changes
Other Study ID Numbers: MRA222JP
First Submitted: September 2, 2005
First Posted: September 5, 2005
Last Update Posted: August 9, 2013
Last Verified: August 2013

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