Clinical Trial: Safety of Etoricoxib (MK-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients

Brief Summary: The study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.

Detailed Summary:

The specific project objectives are to:

1) Describe the characteristics of Swedish patients with inflammatory SpA/AS ; 2) Describe the use of etoricoxib and other cyclooxygenase-2 (COX-2 inhibitors)/non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) in Swedish patients with SpA/AS; and 3) Estimate and compare the rates of clinical outcomes of special interest (gastrointestinal, renovascular, cardiovascular and cerebrovascular) with use of etoricoxib and other COX-2 inhibitors/nsNSAIDs in Swedish patients with SpA/AS. Comparisons of clinical outcomes among the drugs of interest will be made by descriptive comparison of the point estimates for the incidence rates and their associated 95% confidence intervals (CIs), using both clinical and epidemiological judgment and in light of the limitations of this observational study. No formal statistical significance testing will be performed for purposes of such comparisons.


Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Number of patients with Characteristics of inflammatory SPA/AS [ Time Frame: Over a 12 year period (2001-2013) ]
  • Number of patients who used etoricoxib [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ]
  • Number of patients who used other COX-2 inhibitors [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ]
  • Number of patients who used nsNSAIDs [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ]
  • Number of clinical outcomes of special interest [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: March 11, 2011
Date Started: February 2011
Date Completion: November 2017
Last Updated: March 14, 2017
Last Verified: March 2017