NCT01327638

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,108

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2018

Completed
Last Updated

May 10, 2024

Status Verified

February 1, 2022

Enrollment Period

7.6 years

First QC Date

March 11, 2011

Last Update Submit

May 8, 2024

Conditions

Spondylarthropathies; Spondylitis, Ankylosing

Outcome Measures

Primary Outcomes (5)

  • 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)

Study Arms (3)

Patients with SpA/AS and etoricoxib treatment

Drug: etoricoxib

Patients with SpA/AS and other COX-2 inhibitor treatment

Drug: Other COX-2 inhibitor

Patients with SpA/AS and nsNSAIDs treatment

Drug: nsNSAIDs

Interventions

etoricoxibDRUG

Patients with SpA/AS who took etoricoxib

Also known as: MK-0663; Arcoxia
Patients with SpA/AS and etoricoxib treatment
Other COX-2 inhibitorDRUG

Patients with SpA/AS who took other COX-2 inhibitors

Patients with SpA/AS and other COX-2 inhibitor treatment
nsNSAIDsDRUG

Patients with SpA/AS who took nsNSAIDs

Patients with SpA/AS and nsNSAIDs treatment

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Out-patients in Sweden with SpA/AS who took etoricoxib, other COX-2 inhibitors, or nsNSAIDs from 2001-2010.

You may qualify if:

  • 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.

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SpondylarthropathiesSpondylitis

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

SpondylarthritisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesBone Diseases, InfectiousInfections

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2011

First Posted

April 1, 2011

Study Start

February 15, 2011

Primary Completion

September 24, 2018

Study Completion

December 6, 2018

Last Updated

May 10, 2024

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share