Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

Study Overview
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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.

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

Official Title
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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

Conditions
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Rheumatoid Arthritis, Arthritis, Psoriatic, Ankylosing Spondylitis

Intervention / Treatment
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* Drug: systemic non-biological treatments
* Biological: anti-TNF biologics
* Biological: golimumab
* Biological: non-anti-TNF biologics
* Other: general population


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 001<br>golimumab as prescribed | Biological: golimumab<br>* as prescribed<br>|
| 002<br>anti-TNF biologics as prescribed | Biological: anti-TNF biologics<br>* as prescribed<br>|
| 003<br>non-anti-TNF biologics as prescribed | Biological: non-anti-TNF biologics<br>* as prescribed<br>|
| 004<br>systemic non-biological treatments as prescribed | Drug: systemic non-biological treatments<br>* as prescribed<br>|
| 005<br>general population non-treated cohort | Other: general population<br>* non-treated cohort<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | The study will be approximately 8 years in duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, golimumab, anti-TNF biologics, non-anti-TNF biologics, non-biological treatments