Safety Study of Abatacept to Treat Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Arthritis Research Centre of Canada
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01247766
First received: November 23, 2010
Last updated: August 19, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: Yes ]
  • Incidence rates of malignancy [ Time Frame: Every 2 years throughout the study ] [ Designated as safety issue: Yes ]
    (total, lymphoma, lung cancer, breast cancer, colorectal cancer)

  • Total mortality [ Time Frame: Every 2 years throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Multiple sclerosis [ Time Frame: Every 2 years throughout the study ] [ Designated as safety issue: Yes ]
    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
Study Start Date: December 2010
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01247766     History of Changes
Other Study ID Numbers: IM101-213
Study First Received: November 23, 2010
Last Updated: August 19, 2014
Health Authority: European Union: European Medicines Agency

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

ClinicalTrials.gov processed this record on August 28, 2014