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

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

Study Overview

• Status: Completed
• Conditions: Spondylarthropathies; Spondylitis, Ankylosing
• Intervention / Treatment: 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
• Enrollment (Actual): 21108

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• 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.

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?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with SpA/AS and etoricoxib treatment	Drug: etoricoxib; Patients with SpA/AS who took etoricoxib; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

Helpful Links

• EU PAS Register (EUPAS19202)

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2011
• Primary Completion (Actual): September 24, 2018
• Study Completion (Actual): December 6, 2018

Study Registration Dates

• First Submitted: March 11, 2011
• First Submitted That Met QC Criteria: March 31, 2011
• First Posted (Estimated): April 1, 2011

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: February 1, 2022

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; Axial Spondyloarthritis; 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 Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf