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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
ClinicalTrials.gov Identifier:
NCT01077843
First received: February 26, 2010
Last updated: February 27, 2013
Last verified: June 2010
History of Changes
  Purpose

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.


Condition
Ankylosing Spondylitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 11169
Study Start Date: August 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Exposure
Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments
Non-exposure
Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077843

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01077843     History of Changes
Other Study ID Numbers: 0663-163, EP07013.023, 2010_017
Study First Received: February 26, 2010
Last Updated: February 27, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck:
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
 Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013