NCT01081730

Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,040 (actual)
• Sponsor: Janssen Biotech, Inc. · Industry
• Sex: All
• Age: 0 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The patients included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan. The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in psoriasis patients treated with ustekinumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.

Detailed description

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	anti-TNF biologics	as prescribed
OTHER	general population	non-treated cohort
BIOLOGICAL	non-anti-TNF biologics	as prescribed
BIOLOGICAL	ustekinumab	as prescribed
DRUG	systemic non-biological treatments	as prescribed

Timeline

• Start date: 2010-02-09
• Primary completion: 2017-09-29
• Completion: 2017-09-29
• First posted: 2010-03-05
• Last updated: 2025-06-25