Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01088321

Enrollment

81332

Registered

2010-03-17

Start date

2005-03-31

Completion date

2016-11-30

Last updated

2016-12-08

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 among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection	Every four months throughout the study

Secondary

Measure	Time frame
Anaphylactic reactions	Every four months throughout the study
Multiple sclerosis, lupus, and psoriasis	Every four months throughout the study
Concomitant biologic use	Every four months throughout the study

Outcome results