Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

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

Completed

Looking for future studies?

Notify Me

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

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

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

Treatment and study plan

Primary outcomes

Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection

Time frame: Every four months throughout the study

Secondary outcomes

Anaphylactic reactions

Time frame: Every four months throughout the study
Multiple sclerosis, lupus, and psoriasis

Time frame: Every four months throughout the study
Concomitant biologic use

Time frame: Every four months throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2016
Study completion: 2016
First posted: Mar 17, 2010
Registry last updated: Dec 8, 2016

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