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Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

NCT ID: NCT01081717

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1064 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-14

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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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

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Rheumatoid Arthritis Arthritis, Psoriatic Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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001

golimumab as prescribed

golimumab

Intervention Type BIOLOGICAL

as prescribed

002

anti-TNF biologics as prescribed

anti-TNF biologics

Intervention Type BIOLOGICAL

as prescribed

003

non-anti-TNF biologics as prescribed

non-anti-TNF biologics

Intervention Type BIOLOGICAL

as prescribed

004

systemic non-biological treatments as prescribed

systemic non-biological treatments

Intervention Type DRUG

as prescribed

005

general population non-treated cohort

general population

Intervention Type OTHER

non-treated cohort

Interventions

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systemic non-biological treatments

as prescribed

Intervention Type DRUG

anti-TNF biologics

as prescribed

Intervention Type BIOLOGICAL

golimumab

as prescribed

Intervention Type BIOLOGICAL

non-anti-TNF biologics

as prescribed

Intervention Type BIOLOGICAL

general population

non-treated cohort

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Biotech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anja Geldhof, Eng, Ph.D.

Role: STUDY_DIRECTOR

Janssen Biotech, Inc.

Other Identifiers

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CNTO148ART4002

Identifier Type: OTHER

Identifier Source: secondary_id

CR016720

Identifier Type: -

Identifier Source: org_study_id

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