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

Purpose

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.

Condition
Ankylosing Spondylitis


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
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

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Genetic and Rare Diseases Information Center resources: Spondylarthropathy

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Incidence rate of gastrointestinal ulcer, perforation or bleeding [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Incidence rate of fatal or non-fatal hemorrhagic stroke [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Incidence rate of acute renal impairment or failure [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
Incidence rate of hypertension [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
Incidence rate of congestive heart failure or left ventricular dysfunction [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]
Incidence rate of sudden or unexplained death [ Time Frame: First incident event for a given patient through 31-December-2017 ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	11169
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts
Exposure Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
Non-exposure Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077843

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01077843 History of Changes
Other Study ID Numbers:	0663-163 EP07013.023 2010_017
Study First Received:	February 26, 2010
Last Updated:	September 19, 2016
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck Sharp & Dohme Corp.:


Ankylosing Spondylitis

Additional relevant MeSH terms:


Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis Etoricoxib	Anti-Inflammatory Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents

ClinicalTrials.gov processed this record on September 29, 2016