Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Psoriasis

Treatments: Other: general population; Biological: ustekinumab; Biological: anti-TNF biologics; Biological: non-anti-TNF biologics; Drug: systemic non-biological treatments

Study type: Observational

Funder types: Industry

Identifiers

NCT01081730

CR016723

CNTO1275PSO4006 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,040 patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,040 participants in 5 patient groups

001

Description:

ustekinumab as prescribed

Treatment:

Biological: ustekinumab

002

Description:

anti-TNF biologics as prescribed

Treatment:

Biological: anti-TNF biologics

003

Description:

non-anti-TNF biologics as prescribed

Treatment:

Biological: non-anti-TNF biologics

004

Description:

systemic non-biological treatments as prescribed

Treatment:

Drug: systemic non-biological treatments

005

Description:

general population non-treated cohort

Treatment:

Other: general population