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

Completed

• Conditions: Spondylarthropathies; Spondylitis, Ankylosing
• Interventions: Drug: etoricoxib; Drug: Other COX-2 inhibitor; Drug: nsNSAIDs

• Registration Number: NCT01327638
• Lead Sponsor: Organon and Co

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 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.

Study Timeline

• Study Start: 2011-02-15
• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-31
• Study First Posted: 2011-04-01
• Primary Completion: 2018-09-24
• Study Completion: 2018-12-06
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21108

Inclusion Criteria

• Participant attended an out-patient clinic 2001-2010.
• Participant is registered with an International Classification of diseases (ICD, Version 10)-code corresponding to SpA/AS and AS.

Exclusion Criteria

Not applicable.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with SpA/AS and etoricoxib treatment	etoricoxib	-
Patients with SpA/AS and other COX-2 inhibitor treatment	Other COX-2 inhibitor	-
Patients with SpA/AS and nsNSAIDs treatment	nsNSAIDs	-

Primary Outcome Measures

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