Safety of Etoricoxib (MK-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082)

Study Overview
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Brief Summary
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The study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.

Detailed Description
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The specific project objectives are to: 1) Describe the characteristics of Swedish patients with inflammatory SpA/AS ; 2) Describe the use of etoricoxib and other cyclooxygenase-2 (COX-2 inhibitors)/non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) in Swedish patients with SpA/AS; and 3) Estimate and compare the rates of clinical outcomes of special interest (gastrointestinal, renovascular, cardiovascular and cerebrovascular) with use of etoricoxib and other COX-2 inhibitors/nsNSAIDs in Swedish patients with SpA/AS. Comparisons of clinical outcomes among the drugs of interest will be made by descriptive comparison of the point estimates for the incidence rates and their associated 95% confidence intervals (CIs), using both clinical and epidemiological judgment and in light of the limitations of this observational study. No formal statistical significance testing will be performed for purposes of such comparisons.

Official Title
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Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients

Conditions
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Spondylarthropathies; Spondylitis, Ankylosing

Intervention / Treatment
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* Drug: etoricoxib
* Drug: Other COX-2 inhibitor
* Drug: nsNSAIDs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant attended an out-patient clinic 2001-2010. Participant is registered with an International Classification of diseases (ICD, Version 10)-code corresponding to SpA/AS and AS. Exclusion Criteria: Not applicable.

Ages Eligible for Study
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Minimum Age: 16 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 |
| --- | --- |
| Patients with SpA/AS and etoricoxib treatment<br> | Drug: etoricoxib<br>* Patients with SpA/AS who took etoricoxib<br>* Other names: MK-0663; Arcoxia;|
| Patients with SpA/AS and other COX-2 inhibitor treatment<br> | Drug: Other COX-2 inhibitor<br>* Patients with SpA/AS who took other COX-2 inhibitors<br>|
| Patients with SpA/AS and nsNSAIDs treatment<br> | Drug: nsNSAIDs<br>* Patients with SpA/AS who took nsNSAIDs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Characteristics of inflammatory SPA/AS |  | Over a 12 year period (2001-2013) | 
| Number of patients who used etoricoxib |  | Up to 7 1/2 years (Q3 2005 - 2013) | 
| Number of patients who used other COX-2 inhibitors |  | Up to 7 1/2 years (Q3 2005 - 2013) | 
| Number of patients who used nsNSAIDs |  | Up to 7 1/2 years (Q3 2005 - 2013) | 
| Number of clinical outcomes of special interest |  | Up to 7 1/2 years (Q3 2005 - 2013) |