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

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.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: Etoricoxib; Drug: Other Cox-2 inhibitors; Drug: Other Non-selective NSAIDs; Other: No anti-inflammatory treatment

• Study Type: Observational
• Enrollment (Actual): 27381

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposure; Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments	Drug: Etoricoxib; Cox-2 inhibitor; Other Names: ARCOXIA®; Drug: Other Cox-2 inhibitors; Cox-2 inhibitor; Drug: Other Non-selective NSAIDs; Non-selective NSAID
Non-exposure; Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments	Other: No anti-inflammatory treatment; No anti-inflammatory prescription

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

Helpful Links

• EU PAS Register (EUPAS19094)

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2009
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 26, 2010
• First Submitted That Met QC Criteria: February 26, 2010
• First Posted (Estimate): March 1, 2010

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Ankylosing Spondylitis
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anti-Inflammatory Agents; Etoricoxib; Cyclooxygenase 2 Inhibitors
• Other Study ID Numbers: 0663-163

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No