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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01327638
Recruitment Status : Active, not recruiting
First Posted : April 1, 2011
Last Update Posted : December 5, 2017
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.

Study Type : Observational
Estimated Enrollment : 16671 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
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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) ]

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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.

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:

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01327638     History of Changes
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 5, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents