Safety Study of Abatacept to Treat Rheumatoid Arthritis

March 19, 2025 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

6367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Residents of British Columbia who have received health care service for rheumatoid arthritis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious infection
Time Frame: Every 2 years throughout the study
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)
Every 2 years throughout the study
Total mortality
Time Frame: Every 2 years throughout the study
Every 2 years throughout the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 2 years throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Arthritis Research Centre of Canada

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2010

Primary Completion (Actual)

December 31, 2014

Study Completion (Actual)

December 31, 2014

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimated)

November 24, 2010

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe