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
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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COMPLETED
21108 participants
OBSERVATIONAL
2011-02-15
2018-12-06
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients with SpA/AS and etoricoxib treatment
etoricoxib
Patients with SpA/AS who took etoricoxib
Patients with SpA/AS and other COX-2 inhibitor treatment
Other COX-2 inhibitor
Patients with SpA/AS who took other COX-2 inhibitors
Patients with SpA/AS and nsNSAIDs treatment
nsNSAIDs
Patients with SpA/AS who took nsNSAIDs
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is registered with an International Classification of diseases (ICD, Version 10)-code corresponding to SpA/AS and AS.
Exclusion Criteria
16 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Related Links
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EU PAS Register (EUPAS19202)
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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