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Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

NCT01081730 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2040

Last updated 2025-06-25

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

anti-TNF biologics

as prescribed

OTHER

general population

non-treated cohort

BIOLOGICAL

non-anti-TNF biologics

as prescribed

BIOLOGICAL

ustekinumab

as prescribed

DRUG

systemic non-biological treatments

as prescribed

Sponsors & Collaborators

  • Janssen Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Janssen Biologics Europe Clinical Trial · Janssen Biotech, Inc.

Eligibility

Min Age
0 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-09
Primary Completion
2017-09-29
Completion
2017-09-29

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01081730 on ClinicalTrials.gov