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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 : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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 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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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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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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Ages Eligible for Study:   Child, Adult, Older Adult
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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Information from the National Library of Medicine

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


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Additional Information:
EU PAS Register (EUPAS19094)  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01077843     History of Changes
Other Study ID Numbers: 0663-163
First Posted: March 1, 2010    Key Record Dates
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