Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

Rheumatoid Arthritis Clinical Trial

Official title:

Safety of Disease Modifying Antirheumatic Drug (DMARD) and Biologic Treatment of Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088321
• Other study ID #: IM101-045A
• Status: Completed
• Phase: N/A
• First received: March 12, 2010
• Last updated: December 7, 2016
• Start date: March 2005
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEuropean Union: European Medicines Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare the incidence rates of infection among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81332
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis

• Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM

• Age 18 years or older at the time of drug initiation

• Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation

Exclusion Criteria:

• Below 18 years of age at the time of BDM or DMARD initiation

• Lacking six months of continuous enrollment prior to the initiation of one of the study drugs

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection		Every four months throughout the study	Yes
Secondary	Anaphylactic reactions		Every four months throughout the study	Yes
Secondary	Multiple sclerosis, lupus, and psoriasis		Every four months throughout the study	Yes
Secondary	Concomitant biologic use		Every four months throughout the study	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm