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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01077843
First received: February 26, 2010
Last updated: November 20, 2014
Last verified: November 2014

February 26, 2010
November 20, 2014
August 2009
December 2017   (final data collection date for primary outcome measure)
  • 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 ]
  • Incidence rate of gastrointestinal ulcer, perforation or bleeding [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence rate of fatal and non-fatal hemorrhagic stroke [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
  • Incidence rate of deep venous thrombosis or pulmonary embolism [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ 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-2008 ] [ Designated as safety issue: Yes ]
  • Incidence rate of hypertension [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ 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-2008 ] [ Designated as safety issue: Yes ]
  • Incidence rate of sudden or unexplained death [ Time Frame: First incident event for a given patient through 31-December-2008 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01077843 on ClinicalTrials.gov Archive Site
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Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

Ankylosing Spondylitis
Not Provided
  • Exposure
    Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
  • Non-exposure
    Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
11169
December 2017
December 2017   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01077843
0663-163, EP07013.023, 2010_017
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP