Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)
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ClinicalTrials.gov Identifier: NCT01077843 |
Recruitment Status :
Completed
First Posted : March 1, 2010
Last Update Posted : February 18, 2022
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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 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 |

Group/Cohort | Intervention/treatment |
---|---|
Exposure
Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
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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
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Other: No anti-inflammatory treatment
No anti-inflammatory prescription |
- 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 ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077843
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |
Responsible Party: | Organon and Co |
ClinicalTrials.gov Identifier: | NCT01077843 |
Other Study ID Numbers: |
0663-163 |
First Posted: | March 1, 2010 Key Record Dates |
Last Update Posted: | February 18, 2022 |
Last Verified: | February 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ankylosing Spondylitis |
Spondylitis Spondylarthritis Spondylitis, Ankylosing Bone Diseases, Infectious Infections Bone Diseases Musculoskeletal Diseases Spinal Diseases Arthritis Joint Diseases Spondylarthropathies Ankylosis Etoricoxib |
Cyclooxygenase 2 Inhibitors Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |