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

NCT ID: NCT01327638

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-15

Study Completion Date

2018-12-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Spondylarthropathies; Spondylitis, Ankylosing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with SpA/AS and etoricoxib treatment

etoricoxib

Intervention Type DRUG

Patients with SpA/AS who took etoricoxib

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

Other COX-2 inhibitor

Intervention Type DRUG

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

Patients with SpA/AS and nsNSAIDs treatment

nsNSAIDs

Intervention Type DRUG

Patients with SpA/AS who took nsNSAIDs

Interventions

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etoricoxib

Patients with SpA/AS who took etoricoxib

Intervention Type DRUG

Other COX-2 inhibitor

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

Intervention Type DRUG

nsNSAIDs

Patients with SpA/AS who took nsNSAIDs

Intervention Type DRUG

Other Intervention Names

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MK-0663; Arcoxia

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Related Links

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Other Identifiers

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EP07013.013.11.082

Identifier Type: OTHER

Identifier Source: secondary_id

0663-159

Identifier Type: -

Identifier Source: org_study_id

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