Overview

This trial is active, not recruiting.

Condition ankylosing spondylitis
Phase phase 4
Sponsor Merck Sharp & Dohme Corp.
Start date August 2009
End date December 2017
Trial size 11169 participants
Trial identifier NCT01077843, 0663-163, 2010_017, EP07013.023

Summary

This is a descriptive study of a cohort of patients with ankylosing spondylitis and use of etoricoxib in this population. It also includes a nested case-control analysis (when greater than or equal to 700 events of a given type are available for analysis) that will estimate the odds of current exposure to etoricoxib, and to various other anti-inflammatory treatments, compared with non-exposure to any such treatments, for the clinical outcomes of interest in European patients with Ankylosing Spondylitis.

The study population and follow-up time will be refreshed / added to annually, and the analysis re-run annually on a cumulative basis until 2017.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments

Primary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..