NCT01077843

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
• Phase: —
• Study type: Observational
• Enrollment: 27,381 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Etoricoxib	Cox-2 inhibitor
DRUG	Other Cox-2 inhibitors	Cox-2 inhibitor
DRUG	Other Non-selective NSAIDs	Non-selective NSAID
OTHER	No anti-inflammatory treatment	No anti-inflammatory prescription

Timeline

• Start date: 2009-08-17
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2010-03-01
• Last updated: 2022-02-18