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

Spondylarthropathies; Spondylitis, Ankylosing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327638
• Other study ID #: 0663-159
• Secondary ID: EP07013.013.11.0
• Status: Completed
• Start date: February 15, 2011
• Est. completion date: December 6, 2018

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21108
• Est. completion date: December 6, 2018
• Est. primary completion date: September 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylarthropathies
• Spondylarthropathies; Spondylitis, Ankylosing
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• etoricoxib
Patients with SpA/AS who took etoricoxib
• Other COX-2 inhibitor
Patients with SpA/AS who took other COX-2 inhibitors
• nsNSAIDs
Patients with SpA/AS who took nsNSAIDs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

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

External Links

•   EU PAS Register (EUPAS19202)