Clinical trial NCT01077843: Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-03-01
Enrollment: 27381
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will use the combination of the General Practice Research Database (GPRD) in the UK, The Health Improvement Network (THIN) database in the UK, and the IMS Disease Analyzer Database (Disease Analyzer) in the UK, France and Germany.

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.


Eligibility 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

Primary outcomes:
measure: Incidence rate of gastrointestinal ulcer, perforation or bleeding
timeFrame: First incident event for a given patient through 31-December-2017
measure: Incidence rate of fatal or non-fatal acute myocardial infarction or unstable angina pectoris
timeFrame: First incident event for a given patient through 31-December-2017
measure: Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack
timeFrame: First incident event for a given patient through 31-December-2017
measure: Incidence rate of fatal or non-fatal hemorrhagic stroke
timeFrame: First incident event for a given patient through 31-December-2017
measure: Incidence rate of deep venous thrombosis, pulmonary embolism, or peripheral arterial embolism or thrombosis
timeFrame: First incident event for a given patient through 31-December-2017
measure: Incidence rate of acute renal impairment or failure
timeFrame: First incident event for a given patient through 31-December-2017
measure: Incidence rate of hypertension
timeFrame: First incident event for a given patient through 31-December-2017
measure: Incidence rate of congestive heart failure or left ventricular dysfunction
timeFrame: First incident event for a given patient through 31-December-2017
measure: Incidence rate of sudden or unexplained death
timeFrame: First incident event for a given patient through 31-December-2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: