Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

• Status: Completed
• Trial end date: 2017-09-29
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Biotech, Inc.
• Treatments: Ustekinumab

Criteria

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