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
2 other identifiers
observational
2,040
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2010
CompletedFirst Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2017
CompletedJune 25, 2025
June 1, 2025
7.6 years
March 4, 2010
June 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (5)
001
ustekinumab as prescribed
002
anti-TNF biologics as prescribed
003
non-anti-TNF biologics as prescribed
004
systemic non-biological treatments as prescribed
005
general population non-treated cohort
Interventions
Eligibility Criteria
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
You may qualify if:
- Complete medical coverage and pharmacy benefits
- Six months of continuous enrollment prior to the date of cohort entry
You may not qualify if:
- Participants will be excluded if they do not have information on age, gender or enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Biologics Europe Clinical Trial
Janssen Biotech, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
February 9, 2010
Primary Completion
September 29, 2017
Study Completion
September 29, 2017
Last Updated
June 25, 2025
Record last verified: 2025-06