A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments
The participants included in this study will be drawn from the Ingenix Normative Health
Informatics Database, a proprietary research database containing claims and enrollment data
dating back to 1993 for members of a large, geographically diverse US health plan. This
study will include cohorts of participants who have claims consistent with a diagnosis of
rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and who initiate
golimumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological
treatments. Participants will be identified by claims bearing codes for dispensed drugs,
procedures or diagnoses and followed after the launch of golimumab for up to 8 years. A
sample of enrolled health plan members without claims evidence of diagnosis or treatment of
Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis will also be selected.
The claims database will be used to estimate the incidence of the primary outcomes of
serious infections, tuberculosis (TB) and non-TB mycobacterial infections, malignancies such
as lymphoma, and other selected outcomes. No study agents will be administered in this
study. All participants will receive standard-of-care treatment as prescribed by their
Observational Model: Cohort, Time Perspective: Prospective
Estimate incidence of serious infections, malignancies, and other selected outcomes in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis initiating golimumab and other biological and systemic non-biological treatment
The study will be approximately 8 years in duration
Anja Geldhof, Eng, Ph.D.
Janssen Biotech, Inc.
United States: Institutional Review Board
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