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CompletedNCT01327638Updated May 10, 2024

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

An observational study in Spondylarthropathies; Spondylitis, Ankylosing, sponsored by Organon and Co. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by Organon and Co · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
21,108
Ages
16 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Spondylarthropathies; Spondylitis, Ankylosing
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 21,108 is above the median of 202 across 256 observational studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Out-patients in Sweden with SpA/AS who took etoricoxib, other COX-2 inhibitors, or nsNSAIDs from 2001-2010.

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

Exclusion Criteria:

Not applicable.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
21,108 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with SpA/AS and etoricoxib treatment

    Drug: etoricoxib

  • Patients with SpA/AS and other COX-2 inhibitor treatment

    Drug: Other COX-2 inhibitor

  • Patients with SpA/AS and nsNSAIDs treatment

    Drug: nsNSAIDs

Interventions

  • Drugetoricoxib

    Patients with SpA/AS who took etoricoxib

    Also known as: MK-0663; Arcoxia

  • DrugOther COX-2 inhibitor

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

  • DrugnsNSAIDs

    Patients with SpA/AS who took nsNSAIDs

06

What researchers measure

Primary outcomes

  1. Number of patients with Characteristics of inflammatory SPA/AS

    Time frame: Over a 12 year period (2001-2013)

  2. Number of patients who used etoricoxib

    Time frame: Up to 7 1/2 years (Q3 2005 - 2013)

  3. Number of patients who used other COX-2 inhibitors

    Time frame: Up to 7 1/2 years (Q3 2005 - 2013)

  4. Number of patients who used nsNSAIDs

    Time frame: Up to 7 1/2 years (Q3 2005 - 2013)

  5. Number of clinical outcomes of special interest

    Time frame: Up to 7 1/2 years (Q3 2005 - 2013)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01327638
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Apr 1, 2011
Start date
Feb 15, 2011
Primary completion
Sep 24, 2018
Completion
Dec 6, 2018
Last update
May 10, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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