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Completed

NCT Number: NCT01327638

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

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

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Key information

Conditions

Spondylarthropathies; Spondylitis, Ankylosing Arthritis Bone Diseases Bone Diseases, Infectious Infections Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The specific project objectives are to:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etoricoxib

Drug

Patients with SpA/AS who took etoricoxib

Other names: MK-0663; Arcoxia

Other COX-2 inhibitor

Drug

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

nsNSAIDs

Drug

Patients with SpA/AS who took nsNSAIDs

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)

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Apr 1, 2011
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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