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Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

NCT01081717 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1064

Last updated 2025-06-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

systemic non-biological treatments

as prescribed

BIOLOGICAL

anti-TNF biologics

as prescribed

BIOLOGICAL

golimumab

as prescribed

BIOLOGICAL

non-anti-TNF biologics

as prescribed

OTHER

general population

non-treated cohort

Sponsors & Collaborators

  • Janssen Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Anja Geldhof, Eng, Ph.D. · Janssen Biotech, Inc.

Eligibility

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

Timeline & Regulatory

Start
2009-04-14
Primary Completion
2015-05-31
Completion
2015-05-31

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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 NCT01081717 on ClinicalTrials.gov