Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)

NCT ID: NCT01077843

Last Updated: 2022-02-18

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

27381 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-17

Study Completion Date

2015-07-01

Brief Summary

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This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS).

The main objective of the study is to describe in European participants with AS: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.

Detailed Description

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Conditions

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Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Exposure

Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments

Etoricoxib

Intervention Type DRUG

Cox-2 inhibitor

Other Cox-2 inhibitors

Intervention Type DRUG

Cox-2 inhibitor

Other Non-selective NSAIDs

Intervention Type DRUG

Non-selective NSAID

Non-exposure

Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments

No anti-inflammatory treatment

Intervention Type OTHER

No anti-inflammatory prescription

Interventions

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Etoricoxib

Cox-2 inhibitor

Intervention Type DRUG

Other Cox-2 inhibitors

Cox-2 inhibitor

Intervention Type DRUG

Other Non-selective NSAIDs

Non-selective NSAID

Intervention Type DRUG

No anti-inflammatory treatment

No anti-inflammatory prescription

Intervention Type OTHER

Other Intervention Names

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ARCOXIA®

Eligibility Criteria

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Inclusion Criteria

* A recorded Ankylosing Spondylitis diagnosis in the database
* A recorded AS diagnosis following the applicable "acceptable data quality" date for the database that contains the patient's records
* At least 6 months of registered medical records in the database after the applicable "acceptable data quality" date as described above, and prior to the recorded AS diagnosis
* Complete information on gender and birth year
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

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Related Links

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Other Identifiers

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0663-163

Identifier Type: -

Identifier Source: org_study_id

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