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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01077843

Enrollment

27381

Registered

2010-03-01

Start date

2009-08-17

Completion date

2015-07-01

Last updated

2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis

Brief summary

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.

Interventions

DRUGEtoricoxib

Cox-2 inhibitor

DRUGOther Cox-2 inhibitors

Cox-2 inhibitor

DRUGOther Non-selective NSAIDs

Non-selective NSAID

OTHERNo anti-inflammatory treatment

No anti-inflammatory prescription

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026