A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Psoriasis Treated With Ustekinumab 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
psoriasis and who initiate ustekinumab, 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 ustekinumab
for up to 8 years. A sample of enrolled health plan members without claims evidence of
diagnosis or treatment of psoriasis 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. Potential cases of the study outcome identified through claims may be confirmed
through medical record review. No study agents will be administered in this study. All
patients will receive standard-of-care treatment as prescribed by their physician.
Observational Model: Cohort, Time Perspective: Prospective
To estimate the incidence of serious infections, tuberculosis and non-TB mycobacterial infections, malignancies, and other selected outcomes in patients with psoriasis initiating ustekinumab and other biological and systemic non-biological treatments
The study will be approximately 8 years in duration.
Janssen Biologics Europe Clinical Trial
Janssen Biotech, Inc.
United States: New England Institutional Review Board
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