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

Organon

Status

Completed

Conditions

Ankylosing Spondylitis

Treatments

Drug: Other Non-selective NSAIDs

Other: No anti-inflammatory treatment

Drug: Other Cox-2 inhibitors

Drug: Etoricoxib

Study type

Observational

Funder types

Industry

Identifiers

NCT01077843

0663-163

Details and patient eligibility

About

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.

Enrollment

27,381 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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