Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

Sponsor
Janssen Biotech, Inc.
Study ID
NCT01081730
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • anti-TNF biologics — BIOLOGICAL
    as prescribed
  • general population — OTHER
    non-treated cohort
  • non-anti-TNF biologics — BIOLOGICAL
    as prescribed
  • ustekinumab — BIOLOGICAL
    as prescribed
  • systemic non-biological treatments — DRUG
    as prescribed

Study Details

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.

Key Dates

First listed
Mar 5, 2010
Start date
Feb 9, 2010
Status verified
Jun 2025
Primary completion
Sep 29, 2017
Completion
Sep 29, 2017

Study Design

Enrollment
2,040 participants (actual)

Arms

  • Arm: 001
    ustekinumab as prescribed
  • Arm: 002
    anti-TNF biologics as prescribed
  • Arm: 003
    non-anti-TNF biologics as prescribed
  • Arm: 004
    systemic non-biological treatments as prescribed
  • Arm: 005
    general population non-treated cohort

Primary Outcome Measure

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 [ Time Frame: The study will be approximately 8 years in duration. ]

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