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

• ClinicalTrials.gov Identifier: NCT01077843
• Recruitment Status: Completed
• First Posted: March 1, 2010
• Last Update Posted: June 7, 2017
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: February 26, 2010
• First Posted Date: March 1, 2010
• Last Update Posted Date: June 7, 2017
• Actual Study Start Date: August 17, 2009
• Actual Primary Completion Date: July 1, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 30, 2010)

• 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 ]

Original Primary Outcome Measures (submitted: February 26, 2010)

• Incidence rate of gastrointestinal ulcer, perforation or bleeding [ Time Frame: First incident event for a given patient through 31-December-2008 ]
• Incidence rate of fatal and non-fatal acute myocardial infarction and unstable angina pectoris [ Time Frame: First incident event for a given patient through 31-December-2008 ]
• Incidence rate of fatal and non-fatal ischemic stroke, or transient ischemic attack [ Time Frame: First incident event for a given patient through 31-December-2008 ]
• Incidence rate of fatal and non-fatal hemorrhagic stroke [ Time Frame: First incident event for a given patient through 31-December-2008 ]
• Incidence rate of deep venous thrombosis or pulmonary embolism [ Time Frame: First incident event for a given patient through 31-December-2008 ]
• Incidence rate of acute renal impairment or failure [ Time Frame: First incident event for a given patient through 31-December-2008 ]
• Incidence rate of hypertension [ Time Frame: First incident event for a given patient through 31-December-2008 ]
• Incidence rate of congestive heart failure or left ventricular dysfunction [ Time Frame: First incident event for a given patient through 31-December-2008 ]
• Incidence rate of sudden or unexplained death [ Time Frame: First incident event for a given patient through 31-December-2008 ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Ankylosing Spondylitis

Intervention

• Drug: Etoricoxib
  Cox-2 inhibitor
  Other Name: ARCOXIA®
• Drug: Other Cox-2 inhibitors
  Cox-2 inhibitor
• Drug: Other Non-selective NSAIDs
  Non-selective NSAID
• Other: No anti-inflammatory treatment
  No anti-inflammatory prescription

Study Groups/Cohorts

• Exposure
  Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
  Interventions:

  • Drug: Etoricoxib
  • Drug: Other Cox-2 inhibitors
  • Drug: Other Non-selective NSAIDs
• Non-exposure
  Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments
  Intervention: Other: No anti-inflammatory treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 5, 2017): 27381
• Original Estimated Enrollment (submitted: February 26, 2010): 6439
• Actual Study Completion Date: July 1, 2015
• Actual Primary Completion Date: July 1, 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01077843
• Other Study ID Numbers: 0663-163
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Responsible Party: Merck Sharp & Dohme Corp.
• Study Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: June 2017