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Safety Study of Abatacept to Treat Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247766
First Posted: November 24, 2010
Last Update Posted: September 19, 2017
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.
Collaborator:
Arthritis Research Centre of Canada
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications for rheumatoid arthritis.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Observational Study Assessing the Long-term Safety of Abatacept Using a Population-based Cohort of Rheumatoid Arthritis Patients in the Province of British Columbia

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Serious infection [ Time Frame: Every 2 years throughout the study ]
  • Incidence rates of malignancy [ Time Frame: Every 2 years throughout the study ]
    (total, lymphoma, lung cancer, breast cancer, colorectal cancer)

  • Total mortality [ Time Frame: Every 2 years throughout the study ]

Secondary Outcome Measures:
  • Multiple sclerosis [ Time Frame: Every 2 years throughout the study ]
    To determine the incidence rate of multiple sclerosis (MS) in RA patients treated with abatacept and to compare this rate with the rate in RA patients matched for age, gender, RA duration and DMARD use, after adjusting for other potential confounders.


Estimated Enrollment: 8000
Actual Study Start Date: December 31, 2010
Estimated Study Completion Date: November 30, 2018
Estimated Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with rheumatoid arthritis (RA) who receive abatacept
Patients with RA who receive BDM drugs
biologic disease-modifying (BDM)
Patients with RA who receive non-biologic DMARDs
disease-modifying anti-rheumatic drugs (DMARDs)

  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:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Residents of British Columbia who have received health care service for rheumatoid arthritis
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis
  • Receipt of abatacept, other biologic disease-modifying drug, or any non- biologic disease-modifying anti-rheumatic drug
  • Age 18 years or older

Exclusion Criteria:

  • Below 18 years of age
  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): NCT01247766


Sponsors and Collaborators
Bristol-Myers Squibb
Arthritis Research Centre of Canada
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01247766     History of Changes
Other Study ID Numbers: IM101-213
First Submitted: November 23, 2010
First Posted: November 24, 2010
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents