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A Study of Duration of Maintained Efficacy in Rheumatoid Arthritis (RA) Patients Off Treatment With MRA(a Development Code of Tocilizumab, an Anti IL-6 Receptor Monoclonal Antibody.)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00661284
First Posted: April 18, 2008
Last Update Posted: August 2, 2012
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
A 52-week follow up study to investigate the duration of maintenance of efficacy in patients with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study to Investigate the Duration of Maintained Efficacy in Patients With Rheumatoid Arthritis Who Had Treated With MRA

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies. [ Time Frame: every 4th week up to the 48th week ]
  • Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy [ Time Frame: throughout study ]

Secondary Outcome Measures:
  • Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies. [ Time Frame: throughout study ]
  • Efficacy: Time course of DAS28 during the treatment-free period in the present study [ Time Frame: throughout study ]
  • Efficacy: Relationship between serum IL-6 concentration at the last observation of the previous studies and the time course of DAS28 during the treatment-free period in the present study. [ Time Frame: throughout study ]

Enrollment: 189
Study Start Date: April 2008
Study Completion Date: May 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subject who have participated in previous studies and achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject who have participated in previous studies
Criteria

Inclusion Criteria:

  • Patients who achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies.

Exclusion Criteria:

  • Patients who receive DMARDs or immunosuppressants between the last observation in a previous studies and the first observation in this 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): NCT00661284


Locations
Japan
Chugoku region
Chugoku, Japan
Kanto region
Kanto, Japan
Kyushu region
Kyushu, Japan
Sikoku region
Sikoku, Japan
Tohoku region
Tohoku, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Chair: Yuji Kimura Chugai Pharmaceutical,Clinical Research Department 1
  More Information

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00661284     History of Changes
Other Study ID Numbers: MRA226JP
First Submitted: April 15, 2008
First Posted: April 18, 2008
Last Update Posted: August 2, 2012
Last Verified: July 2012

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