Safety Study of Abatacept to Treat Rheumatoid Arthritis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01247766

Enrollment

6367

Registered

2010-11-24

Start date

2010-12-31

Completion date

2014-12-31

Last updated

2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Serious infection	Every 2 years throughout the study	—
Incidence rates of malignancy	Every 2 years throughout the study	(total, lymphoma, lung cancer, breast cancer, colorectal cancer)
Total mortality	Every 2 years throughout the study	—

Secondary

Measure	Time frame	Description
Multiple sclerosis	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.

Outcome results