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

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: NCT00144586
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : August 9, 2013
Information provided by (Responsible Party):
Chugai Pharmaceutical

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: MRA(Tocilizumab) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Study Start Date : March 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: MRA(Tocilizumab)
8mg/kg/4 weeks

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

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

  • 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

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): NCT00144586

Sponsors and Collaborators
Chugai Pharmaceutical
Study Director: Yuji Kimura Chugai Pharmaceutical

Responsible Party: Chugai Pharmaceutical Identifier: NCT00144586     History of Changes
Other Study ID Numbers: MRA222JP
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

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