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

NCT01077843 | Completed

• 1 other identifier: 0663-163
• Study Type: observational
• Target: 27,381
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (9)

• Incidence rate of gastrointestinal ulcer, perforation or bleeding

  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

  First incident event for a given patient through 31-December-2017

• Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack

  First incident event for a given patient through 31-December-2017

• Incidence rate of fatal or non-fatal hemorrhagic stroke

  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

  First incident event for a given patient through 31-December-2017

• Incidence rate of acute renal impairment or failure

  First incident event for a given patient through 31-December-2017

• Incidence rate of hypertension

  First incident event for a given patient through 31-December-2017

• Incidence rate of congestive heart failure or left ventricular dysfunction

  First incident event for a given patient through 31-December-2017

• Incidence rate of sudden or unexplained death

  First incident event for a given patient through 31-December-2017

Study Arms (2)

Exposure

Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments

Drug: Etoricoxib; Drug: Other Cox-2 inhibitors; Drug: Other Non-selective NSAIDs

Non-exposure

Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments

Other: No anti-inflammatory treatment

Interventions

Etoricoxib DRUG

Cox-2 inhibitor

Also known as: ARCOXIA®

Exposure

Other Cox-2 inhibitors DRUG

Cox-2 inhibitor

Exposure

Other Non-selective NSAIDs DRUG

Non-selective NSAID

Exposure

No anti-inflammatory treatment OTHER

No anti-inflammatory prescription

Non-exposure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Links

• EU PAS Register (EUPAS19094)

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 1, 2010
• Study Start: August 17, 2009
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 18, 2022

Record last verified: 2022-02