Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081717
• Other study ID #: CR016720
• Secondary ID: CNTO148ART4002
• Status: Completed
• Start date: April 14, 2009
• Est. completion date: May 31, 2015

Study information

• Verified date: July 2019
• Source: Janssen Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1064
• Est. completion date: May 31, 2015
• Est. primary completion date: May 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

Inclusion Criteria:

• Complete medical coverage and pharmacy benefits

• Six months of continuous enrollment prior to the date of cohort entry

Exclusion Criteria:

• Participants will be excluded if they do not have information on age, gender or enrollment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• systemic non-biological treatments
as prescribed

Biological:
• anti-TNF biologics
as prescribed
• golimumab
as prescribed
• non-anti-TNF biologics
as prescribed

Other:
• general population
non-treated cohort

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Biotech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		The study will be approximately 8 years in duration