Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

July 2, 2019 updated by: Janssen Biotech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

1064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will include cohorts of patients who have claims consistent with a diagnosis of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who initiate golimumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments, within the Ingenix Normative Health Informatics Database.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
golimumab as prescribed
Biological: golimumab
as prescribed
002
anti-TNF biologics as prescribed
Biological: anti-TNF biologics
as prescribed
003
non-anti-TNF biologics as prescribed
Biological: non-anti-TNF biologics
as prescribed
004
systemic non-biological treatments as prescribed
Drug: systemic non-biological treatments
as prescribed
005
general population non-treated cohort
Other: general population
non-treated cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The study will be approximately 8 years in duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Biotech, Inc.

Investigators

  • Study Director: Anja Geldhof, Eng, Ph.D., Janssen Biotech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2009

Primary Completion (Actual)

May 31, 2015

Study Completion (Actual)

May 31, 2015

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (Estimate)

March 5, 2010

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016720
  • CNTO148ART4002 (Other Identifier: Janssen Biotech, Inc.)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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