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Clinical trial

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

ID
Name
0663-159
Description
The study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.
Trial arms
Trial start
2011-02-15
Estimated PCD
2018-09-24
Trial end
2018-12-06
Status
Completed
Treatment
etoricoxib
Patients with SpA/AS who took etoricoxib
Arms:
Patients with SpA/AS and etoricoxib treatment
Other names:
MK-0663; Arcoxia
Other COX-2 inhibitor
Patients with SpA/AS who took other COX-2 inhibitors
Arms:
Patients with SpA/AS and other COX-2 inhibitor treatment
nsNSAIDs
Patients with SpA/AS who took nsNSAIDs
Arms:
Patients with SpA/AS and nsNSAIDs treatment
Size
21108
Primary endpoint
Number of patients with Characteristics of inflammatory SPA/AS
Over a 12 year period (2001-2013)
Number of patients who used etoricoxib
Up to 7 1/2 years (Q3 2005 - 2013)
Number of patients who used other COX-2 inhibitors
Up to 7 1/2 years (Q3 2005 - 2013)
Number of patients who used nsNSAIDs
Up to 7 1/2 years (Q3 2005 - 2013)
Number of clinical outcomes of special interest
Up to 7 1/2 years (Q3 2005 - 2013)
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 21108, 'type': 'ACTUAL'}}
Updated at
2024-05-10

1 organization

3 products

2 indications

Organization
Organon and Co
Product
etoricoxib
Indication
Spondylarthropathies
Indication
Ankylosing spondylitis
Product
COX-2 inhibitor
Product
nsNSAIDs