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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077843
• Other study ID #: 0663-163
• Status: Completed
• Start date: August 17, 2009
• Est. completion date: July 1, 2015

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27381
• Est. completion date: July 1, 2015
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Etoricoxib
Cox-2 inhibitor
• Other Cox-2 inhibitors
Cox-2 inhibitor
• Other Non-selective NSAIDs
Non-selective NSAID

Other:
• No anti-inflammatory treatment
No anti-inflammatory prescription

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of gastrointestinal ulcer, perforation or bleeding		First incident event for a given patient through 31-December-2017
Primary	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
Primary	Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack		First incident event for a given patient through 31-December-2017
Primary	Incidence rate of fatal or non-fatal hemorrhagic stroke		First incident event for a given patient through 31-December-2017
Primary	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
Primary	Incidence rate of acute renal impairment or failure		First incident event for a given patient through 31-December-2017
Primary	Incidence rate of hypertension		First incident event for a given patient through 31-December-2017
Primary	Incidence rate of congestive heart failure or left ventricular dysfunction		First incident event for a given patient through 31-December-2017
Primary	Incidence rate of sudden or unexplained death		First incident event for a given patient through 31-December-2017

External Links

•   EU PAS Register (EUPAS19094)