NCT01327638

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21,108 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Spondylarthropathies; Spondylitis, Ankylosing

Interventions

Type	Name	Description
DRUG	etoricoxib	Patients with SpA/AS who took etoricoxib
DRUG	Other COX-2 inhibitor	Patients with SpA/AS who took other COX-2 inhibitors
DRUG	nsNSAIDs	Patients with SpA/AS who took nsNSAIDs

Timeline

• Start date: 2011-02-15
• Primary completion: 2018-09-24
• Completion: 2018-12-06
• First posted: 2011-04-01
• Last updated: 2024-05-10