Safety Study of Abatacept to Treat Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

Arthritis Research Centre of Canada

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Nov 24, 2010
Registry last updated: Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed