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

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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