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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01327638

Enrollment

21108

Registered

2011-04-01

Start date

2011-02-15

Completion date

2018-12-06

Last updated

2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylarthropathies; Spondylitis, Ankylosing

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.

Interventions

DRUGetoricoxib

Patients with SpA/AS who took etoricoxib

DRUGOther COX-2 inhibitor

Patients with SpA/AS who took other COX-2 inhibitors

DRUGnsNSAIDs

Patients with SpA/AS who took nsNSAIDs

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of patients who used other COX-2 inhibitors	Up to 7 1/2 years (Q3 2005 - 2013)
Number of patients who used etoricoxib	Up to 7 1/2 years (Q3 2005 - 2013)
Number of patients with Characteristics of inflammatory SPA/AS	Over a 12 year period (2001-2013)
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026