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

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Other: No anti-inflammatory treatment; Drug: Etoricoxib; Drug: Other Cox-2 inhibitors; Drug: Other Non-selective NSAIDs

• Registration Number: NCT01077843
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-17
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-02-26
• Study First Posted: 2010-03-01
• Primary Completion: 2015-07-01
• Study Completion: 2015-07-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27381

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-exposure	No anti-inflammatory treatment	Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments
Exposure	Other Non-selective NSAIDs	Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
Exposure	Other Cox-2 inhibitors	Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
Exposure	Etoricoxib	Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments

Primary Outcome Measures

Name	Time	Method
Incidence rate of fatal or non-fatal hemorrhagic stroke	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 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 sudden or unexplained death	First incident event for a given patient through 31-December-2017
Incidence rate of gastrointestinal ulcer, perforation or bleeding	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