Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01088360

Enrollment

20000

Registered

2010-03-17

Start date

2005-03-31

Completion date

2029-06-30

Last updated

2019-01-18

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 targeted infections, malignancies and mortality 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

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Signed informed consent * Diagnosis of rheumatoid arthritis * \> 18 years at index treatment initiation or switch * Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug. * Read/write English

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Key safety outcomes (targeted infections, malignancies, mortality)	Every 6 months throughout the study

Secondary

Measure	Time frame
Patient-reported infusion reactions	Every 6 months throughout the study
Multiple sclerosis, lupus, and psoriasis	Every 6 months throughout the study
Adverse events in pregnant women who receive abatacept	Every 6 months throughout the study
Adverse events in subjects on abatacept who receive concomitant biologics	Every 6 months throughout the study

Outcome results