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

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ClinicalTrials.gov Identifier: NCT01327638
Recruitment Status : Completed
First Posted : April 1, 2011
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment
Spondylarthropathies; Spondylitis, Ankylosing Drug: etoricoxib Drug: Other COX-2 inhibitor Drug: nsNSAIDs

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.

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Study Type : Observational
Actual Enrollment : 21108 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients
Actual Study Start Date : February 15, 2011
Actual Primary Completion Date : September 24, 2018
Actual Study Completion Date : December 6, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with SpA/AS and etoricoxib treatment Drug: etoricoxib
Patients with SpA/AS who took etoricoxib
Other Name: MK-0663; Arcoxia

Patients with SpA/AS and other COX-2 inhibitor treatment Drug: Other COX-2 inhibitor
Patients with SpA/AS who took other COX-2 inhibitors

Patients with SpA/AS and nsNSAIDs treatment Drug: nsNSAIDs
Patients with SpA/AS who took nsNSAIDs




Primary Outcome Measures :
  1. Number of patients with Characteristics of inflammatory SPA/AS [ Time Frame: Over a 12 year period (2001-2013) ]
  2. Number of patients who used etoricoxib [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ]
  3. Number of patients who used other COX-2 inhibitors [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ]
  4. Number of patients who used nsNSAIDs [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ]
  5. Number of clinical outcomes of special interest [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Out-patients in Sweden with SpA/AS who took etoricoxib, other COX-2 inhibitors, or nsNSAIDs from 2001-2010.
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.

Additional Information:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01327638    
Other Study ID Numbers: 0663-159
EP07013.013.11.082 ( Other Identifier: Merck )
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Spondylarthropathies
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Ankylosis
Joint Diseases
Arthritis
Etoricoxib
Cyclooxygenase 2 Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action