Ankylosing SpondylitisNCT01077843
Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)
An observational study of Ankylosing Spondylitis, run by Organon and Co.
Trial summary
This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Etoricoxib, Other Cox-2 inhibitors and Other Non-selective NSAIDs
- How many people
- 27,381 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2009to 1 Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will use the combination of the General Practice Research Database (GPRD) in the UK, The Health Improvement Network (THIN) database in the UK, and the IMS Disease Analyzer Database (Disease Analyzer) in the UK, France and Germany.
Who may be able to join
- A recorded Ankylosing Spondylitis diagnosis in the database
- A recorded AS diagnosis following the applicable "acceptable data quality" date for the database that contains the patient's records
- At least 6 months of registered medical records in the database after the applicable "acceptable data quality" date as described above, and prior to the recorded AS diagnosis
- Complete information on gender and birth year
Who cannot join
None listed.
About this study
Official title: A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in a Cohort of Patients With Ankylosing Spondylitis (AS) in the UK, France and Germany
This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS).
The main objective of the study is to describe in European participants with AS: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Etoricoxib, Other Cox-2 inhibitors, Other Non-selective NSAIDs, No anti-inflammatory treatment
- Keywords
- Ankylosing Spondylitis
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
Also called ARCOXIA®
Cox-2 inhibitor
Other Cox-2 inhibitorsDrug
Cox-2 inhibitor
Other Non-selective NSAIDsDrug
Non-selective NSAID
No anti-inflammatory treatmentOther
No anti-inflammatory prescription
| Study group | Role | What they receive |
|---|---|---|
| Exposure | Ankylosing spondylitis patients currently exposed to anti-inflammatory treatments Receives: Drug: Etoricoxib; Drug: Other Cox-2 inhibitors; Drug: Other Non-selective NSAIDs | |
| Non-exposure | Ankylosing spondylitis patients not currently exposed to anti-inflammatory treatments Receives: Other: No anti-inflammatory treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of gastrointestinal ulcer, perforation or bleeding
Measured: First incident event for a given patient through 31-December-2017
Incidence rate of fatal or non-fatal acute myocardial infarction or unstable angina pectoris
Measured: First incident event for a given patient through 31-December-2017
Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack
Measured: First incident event for a given patient through 31-December-2017
Incidence rate of fatal or non-fatal hemorrhagic stroke
Measured: First incident event for a given patient through 31-December-2017
Incidence rate of deep venous thrombosis, pulmonary embolism, or peripheral arterial embolism or thrombosis
Measured: First incident event for a given patient through 31-December-2017
Incidence rate of acute renal impairment or failure
Measured: First incident event for a given patient through 31-December-2017
Incidence rate of hypertension
Measured: First incident event for a given patient through 31-December-2017
Incidence rate of congestive heart failure or left ventricular dysfunction
Measured: First incident event for a given patient through 31-December-2017
Incidence rate of sudden or unexplained death
Measured: First incident event for a given patient through 31-December-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study start17 Aug 2009
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- 27,381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077843
- Sponsor's protocol ID
- 0663-163
- Status last verified
- Feb 2022
- First submitted
- 26 Feb 2010
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in a Cohort of Patients With Ankylosing Spondylitis (AS) in the UK, France and Germany
- ClinicalTrials.gov ID
- NCT01077843
- Acronym / sponsor ID
- 0663-163
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,381 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2009 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 1 Mar 2010 (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.
This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS).
The main objective of the study is to describe in European participants with AS: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure | – | Drug: Etoricoxib, Drug: Other Cox-2 inhibitors, Drug: Other Non-selective NSAIDsAnkylosing spondylitis patients currently exposed to anti-inflammatory treatments |
| Non-exposure | – | Other: No anti-inflammatory treatmentAnkylosing spondylitis patients not currently exposed to anti-inflammatory treatments |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will use the combination of the General Practice Research Database (GPRD) in the UK, The Health Improvement Network (THIN) database in the UK, and the IMS Disease Analyzer Database (Disease Analyzer) in the UK, France and Germany.
Key inclusion criteria (4 listed)
- A recorded Ankylosing Spondylitis diagnosis in the database
- A recorded AS diagnosis following the applicable "acceptable data quality" date for the database that contains the patient's records
- At least 6 months of registered medical records in the database after the applicable "acceptable data quality" date as described above, and prior to the recorded AS diagnosis
- Complete information on gender and birth year
Key exclusion criteria (0 listed)
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: ARCOXIA®Cox-2 inhibitor | Drug | Exposure |
| Other Cox-2 inhibitorsCox-2 inhibitor | Drug | Exposure |
| Other Non-selective NSAIDsNon-selective NSAID | Drug | Exposure |
| No anti-inflammatory treatmentNo anti-inflammatory prescription | Other | Non-exposure |
Primary outcome
Incidence rate of gastrointestinal ulcer, perforation or bleeding
Time frame: First incident event for a given patient through 31-December-2017
Incidence rate of fatal or non-fatal acute myocardial infarction or unstable angina pectoris
Time frame: First incident event for a given patient through 31-December-2017
Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack
Time frame: First incident event for a given patient through 31-December-2017
Incidence rate of fatal or non-fatal hemorrhagic stroke
Time frame: First incident event for a given patient through 31-December-2017
Incidence rate of deep venous thrombosis, pulmonary embolism, or peripheral arterial embolism or thrombosis
Time frame: First incident event for a given patient through 31-December-2017
Incidence rate of acute renal impairment or failure
Time frame: First incident event for a given patient through 31-December-2017
Incidence rate of hypertension
Time frame: First incident event for a given patient through 31-December-2017
Incidence rate of congestive heart failure or left ventricular dysfunction
Time frame: First incident event for a given patient through 31-December-2017
Incidence rate of sudden or unexplained death
Time frame: First incident event for a given patient through 31-December-2017
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 18 Feb 2022.
- EU PAS Register (EUPAS19094)Link provided by the sponsor.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, 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 4 inclusion and 0 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 18 Feb 2022. 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?
Incidence rate of gastrointestinal ulcer, perforation or bleeding (time frame: First incident event for a given patient through 31-December-2017). The study lists 9 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 18 Feb 2022.