Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

Completed

• Conditions: Psoriasis
• Interventions: Biological: non-anti-TNF biologics; Drug: systemic non-biological treatments; Biological: ustekinumab; Biological: anti-TNF biologics; Other: general population

• Registration Number: NCT01081730
• Lead Sponsor: Janssen Biotech, Inc.

Brief 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.

Study Timeline

• Study Start: 2010-02-09
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2040

Inclusion Criteria

• Complete medical coverage and pharmacy benefits
• Six months of continuous enrollment prior to the date of cohort entry

Exclusion Criteria

• Participants will be excluded if they do not have information on age, gender or enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
003	non-anti-TNF biologics	non-anti-TNF biologics as prescribed
004	systemic non-biological treatments	systemic non-biological treatments as prescribed
001	ustekinumab	ustekinumab as prescribed
002	anti-TNF biologics	anti-TNF biologics as prescribed
005	general population	general population non-treated cohort

Primary Outcome Measures

Name	Time	Method
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.