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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01327638
First received: March 11, 2011
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of patients with Characteristics of inflammatory SPA/AS [ Time Frame: Over a 12 year period (2001-2013) ] [ Designated as safety issue: No ]
  • Number of patients who used etoricoxib [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ] [ Designated as safety issue: Yes ]
  • Number of patients who used other COX-2 inhibitors [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ] [ Designated as safety issue: Yes ]
  • Number of patients who used nsNSAIDs [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ] [ Designated as safety issue: Yes ]
  • Number of clinical outcomes of special interest [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16671
Study Start Date: February 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01327638     History of Changes
Other Study ID Numbers: 0663-159, EP07013.013.11.082
Study First Received: March 11, 2011
Last Updated: April 9, 2014
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Spondylarthropathies
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014