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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Ankylosing Spondylitis	Drug: Etoricoxib; Drug: Other Cox-2 inhibitors; Drug: Other Non-selective NSAIDs; Other: No anti-inflammatory treatment

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	27381 participants
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
Actual Study Start Date :	August 17, 2009
Actual Primary Completion Date :	July 1, 2015
Actual Study Completion Date :	July 1, 2015

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Exposure; Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments	Drug: Etoricoxib; Cox-2 inhibitor; Other Name: 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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Incidence rate of gastrointestinal ulcer, perforation or bleeding [ Time Frame: First incident event for a given patient through 31-December-2017 ]
2. 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 ]
3. 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 ]
4. Incidence rate of fatal or non-fatal hemorrhagic stroke [ Time Frame: First incident event for a given patient through 31-December-2017 ]
5. 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 ]
6. Incidence rate of acute renal impairment or failure [ Time Frame: First incident event for a given patient through 31-December-2017 ]
7. Incidence rate of hypertension [ Time Frame: First incident event for a given patient through 31-December-2017 ]
8. Incidence rate of congestive heart failure or left ventricular dysfunction [ Time Frame: First incident event for a given patient through 31-December-2017 ]
9. Incidence rate of sudden or unexplained death [ Time Frame: First incident event for a given patient through 31-December-2017 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

EU PAS Register (EUPAS19094) 

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01077843 History of Changes
Other Study ID Numbers:	0663-163
First Posted:	March 1, 2010
Last Update Posted:	June 7, 2017
Last Verified:	June 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

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