- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01327638
Safety of Etoricoxib (MK-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082)
Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with SpA/AS and etoricoxib treatment
|
Patients with SpA/AS who took etoricoxib
Other Names:
|
Patients with SpA/AS and other COX-2 inhibitor treatment
|
Patients with SpA/AS who took other COX-2 inhibitors
|
Patients with SpA/AS and nsNSAIDs treatment
|
Patients with SpA/AS who took nsNSAIDs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with Characteristics of inflammatory SPA/AS
Time Frame: Over a 12 year period (2001-2013)
|
Over a 12 year period (2001-2013)
|
Number of patients who used etoricoxib
Time Frame: Up to 7 1/2 years (Q3 2005 - 2013)
|
Up to 7 1/2 years (Q3 2005 - 2013)
|
Number of patients who used other COX-2 inhibitors
Time Frame: Up to 7 1/2 years (Q3 2005 - 2013)
|
Up to 7 1/2 years (Q3 2005 - 2013)
|
Number of patients who used nsNSAIDs
Time Frame: Up to 7 1/2 years (Q3 2005 - 2013)
|
Up to 7 1/2 years (Q3 2005 - 2013)
|
Number of clinical outcomes of special interest
Time Frame: Up to 7 1/2 years (Q3 2005 - 2013)
|
Up to 7 1/2 years (Q3 2005 - 2013)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Spinal Diseases
- Bone Diseases
- Bone Diseases, Infectious
- Ankylosis
- Spondylitis
- Spondylarthritis
- Spondylitis, Ankylosing
- Spondylarthropathies
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Etoricoxib
- Cyclooxygenase 2 Inhibitors
Other Study ID Numbers
- 0663-159
- EP07013.013.11.082 (OTHER: Merck)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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