Safety Study of Abatacept to Treat Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01247766
• Other study ID #: IM101-213
• Status: Active, not recruiting
• First received: November 23, 2010
• Last updated: March 26, 2018
• Start date: December 31, 2010
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8000
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Arthritis Research Centre of Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious infection		Every 2 years throughout the study
Primary	Incidence rates of malignancy	(total, lymphoma, lung cancer, breast cancer, colorectal cancer)	Every 2 years throughout the study
Primary	Total mortality		Every 2 years throughout the study
Secondary	Multiple sclerosis	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form