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:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00661284
First received: April 15, 2008
Last updated: July 31, 2012
Last verified: July 2012
  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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Efficacy: Time course of DAS28 during the treatment-free period in the present study [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00661284     History of Changes
Other Study ID Numbers: MRA226JP
Study First Received: April 15, 2008
Last Updated: July 31, 2012
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014