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

Organon and Co27,381 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

27,381

Conditions

Ankylosing Spondylitis

Interventions

EtoricoxibDRUG

Cox-2 inhibitor

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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