NCT01081717

Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,064 (actual)
• Sponsor: Janssen Biotech, Inc. · Industry
• Sex: All
• Age: 0 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The participants included in this study will be drawn from the Ingenix Normative Health Informatics Database, a proprietary research database containing claims and enrollment data dating back to 1993 for members of a large, geographically diverse US health plan. This study will include cohorts of participants who have claims consistent with a diagnosis of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and who initiate golimumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments. Participants will be identified by claims bearing codes for dispensed drugs, procedures or diagnoses and followed after the launch of golimumab for up to 8 years. A sample of enrolled health plan members without claims evidence of diagnosis or treatment of Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis will also be selected. The claims database will be used to estimate the incidence of the primary outcomes of serious infections, tuberculosis (TB) and non-TB mycobacterial infections, malignancies such as lymphoma, and other selected outcomes. No study agents will be administered in this study. All participants will receive standard-of-care treatment as prescribed by their physician

Conditions

• Rheumatoid Arthritis
• Arthritis, Psoriatic
• Ankylosing Spondylitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-04-14
• Primary completion: 2015-05-31
• Completion: 2015-05-31
• First posted: 2010-03-05
• Last updated: 2025-06-25