Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

Sponsor
Janssen Biotech, Inc.
Study ID
NCT01081717
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The participants 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 rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients treated with golimumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.

Key Dates

Start date
Apr 14, 2009
Status verified
Jun 2025
Primary completion
May 31, 2015
Completion
May 31, 2015

Study Design

Enrollment
1,064 participants (actual)

Arms

  • Arm: 001
    golimumab 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

Estimate incidence of serious infections, malignancies, and other selected outcomes in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis initiating golimumab and other biological and systemic non-biological treatment [ Time Frame: The study will be approximately 8 years in duration ]

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