Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)

Study Overview
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Brief Summary
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This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS). The main objective of the study is to describe in European participants with AS: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.

Official Title
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A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in a Cohort of Patients With Ankylosing Spondylitis (AS) in the UK, France and Germany

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Drug: Etoricoxib
* Drug: Other Cox-2 inhibitors
* Drug: Other Non-selective NSAIDs
* Other: No anti-inflammatory treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A recorded Ankylosing Spondylitis diagnosis in the database A recorded AS diagnosis following the applicable acceptable data quality date for the database that contains the patient's records At least 6 months of registered medical records in the database after the applicable acceptable data quality date as described above, and prior to the recorded AS diagnosis Complete information on gender and birth year
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 |
| --- | --- |
| Exposure<br>Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments | Drug: Etoricoxib<br>* Cox-2 inhibitor<br>* Other names: ARCOXIA®;Drug: Other Cox-2 inhibitors<br>* Cox-2 inhibitor<br>Drug: Other Non-selective NSAIDs<br>* Non-selective NSAID<br>|
| Non-exposure<br>Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments | Other: No anti-inflammatory treatment<br>* No anti-inflammatory prescription<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of gastrointestinal ulcer, perforation or bleeding |  | First incident event for a given patient through 31-December-2017 | 
| Incidence rate of fatal or non-fatal acute myocardial infarction or unstable angina pectoris |  | First incident event for a given patient through 31-December-2017 | 
| Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack |  | First incident event for a given patient through 31-December-2017 | 
| Incidence rate of fatal or non-fatal hemorrhagic stroke |  | First incident event for a given patient through 31-December-2017 | 
| Incidence rate of deep venous thrombosis, pulmonary embolism, or peripheral arterial embolism or thrombosis |  | First incident event for a given patient through 31-December-2017 | 
| Incidence rate of acute renal impairment or failure |  | First incident event for a given patient through 31-December-2017 | 
| Incidence rate of hypertension |  | First incident event for a given patient through 31-December-2017 | 
| Incidence rate of congestive heart failure or left ventricular dysfunction |  | First incident event for a given patient through 31-December-2017 | 
| Incidence rate of sudden or unexplained death |  | First incident event for a given patient through 31-December-2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankylosing Spondylitis