Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081730
• Other study ID #: CR016723
• Secondary ID: CNTO1275PSO4006
• Status: Completed
• Start date: February 9, 2010
• Est. completion date: September 29, 2017

Study information

• Verified date: February 2019
• Source: Janssen Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2040
• Est. completion date: September 29, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• anti-TNF biologics
as prescribed

Other:
• general population
non-treated cohort

Biological:
• non-anti-TNF biologics
as prescribed
• ustekinumab
as prescribed

Drug:
• systemic non-biological treatments
as prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Biotech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.