Spondylarthropathies; Spondylitis, AnkylosingNCT01327638
Safety of Etoricoxib (MK-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082)
An observational study of Spondylarthropathies; Spondylitis, Ankylosing, run by Organon and Co.
Trial summary
The study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spondylarthropathies; Spondylitis, Ankylosing
- What is being tested?
- etoricoxib, Other COX-2 inhibitor and nsNSAIDs
- How many people
- 21,108 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2011to 6 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Out-patients in Sweden with SpA/AS who took etoricoxib, other COX-2 inhibitors, or nsNSAIDs from 2001-2010.
Who may be able to join
- 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.
Who cannot join
- Not applicable.
About this study
Official title: 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.
Read the detailed description
The specific project objectives are to:
- 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.
- Being tested
- etoricoxib, Other COX-2 inhibitor, nsNSAIDs
- Medical subject headings
- Spondylarthropathies, Spondylitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoricoxibDrug
Also called MK-0663; Arcoxia
Patients with SpA/AS who took etoricoxib
Other COX-2 inhibitorDrug
Patients with SpA/AS who took other COX-2 inhibitors
nsNSAIDsDrug
Patients with SpA/AS who took nsNSAIDs
| Study group | Role | What they receive |
|---|---|---|
| Patients with SpA/AS and etoricoxib treatment | Not described Receives: Drug: etoricoxib | |
| Patients with SpA/AS and other COX-2 inhibitor treatment | Not described Receives: Drug: Other COX-2 inhibitor | |
| Patients with SpA/AS and nsNSAIDs treatment | Not described Receives: Drug: nsNSAIDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Characteristics of inflammatory SPA/AS
Measured: Over a 12 year period (2001-2013)
Number of patients who used etoricoxib
Measured: Up to 7 1/2 years (Q3 2005 - 2013)
Number of patients who used other COX-2 inhibitors
Measured: Up to 7 1/2 years (Q3 2005 - 2013)
Number of patients who used nsNSAIDs
Measured: Up to 7 1/2 years (Q3 2005 - 2013)
Number of clinical outcomes of special interest
Measured: Up to 7 1/2 years (Q3 2005 - 2013)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study start15 Feb 2011
- Primary completion24 Sep 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondylarthropathies; Spondylitis, AnkylosingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327638
- Sponsor's protocol ID
- 0663-159
- Other IDs
- EP07013.013.11.082
- Status last verified
- Feb 2022
- First submitted
- 11 Mar 2011
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients
- ClinicalTrials.gov ID
- NCT01327638
- Acronym / sponsor ID
- 0663-159
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,108 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2011 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.
Detailed description
The specific project objectives are to:
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Out-patients in Sweden with SpA/AS who took etoricoxib, other COX-2 inhibitors, or nsNSAIDs from 2001-2010.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etoricoxibAlso: MK-0663; ArcoxiaPatients with SpA/AS who took etoricoxib | Drug | Patients with SpA/AS and etoricoxib treatment |
| Other COX-2 inhibitorPatients with SpA/AS who took other COX-2 inhibitors | Drug | Patients with SpA/AS and other COX-2 inhibitor treatment |
| nsNSAIDsPatients with SpA/AS who took nsNSAIDs | Drug | Patients with SpA/AS and nsNSAIDs treatment |
Primary outcome
Number of patients with Characteristics of inflammatory SPA/AS
Time frame: Over a 12 year period (2001-2013)
Number of patients who used etoricoxib
Time frame: Up to 7 1/2 years (Q3 2005 - 2013)
Number of patients who used other COX-2 inhibitors
Time frame: Up to 7 1/2 years (Q3 2005 - 2013)
Number of patients who used nsNSAIDs
Time frame: Up to 7 1/2 years (Q3 2005 - 2013)
Number of clinical outcomes of special interest
Time frame: Up to 7 1/2 years (Q3 2005 - 2013)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- EU PAS Register (EUPAS19202)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylarthropathies; Spondylitis, Ankylosing, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Characteristics of inflammatory SPA/AS (time frame: Over a 12 year period (2001-2013)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.