GoutNCT04853160
Drug Use Study of Febuxostat After Recent Changes in the Prescribing Information
An observational study of Gout and Cardiovascular Diseases, run by Takeda at 1 site in United States.
Trial summary
The prescribing information provides information on medicines. This study will check the number of patients starting febuxostat and the number of febuxostat users with cardiovascular disease after changes to the prescribing information. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Gout, Cardiovascular Diseases
- How many people
- 24,046 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2020to 5 Jan 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with gout initiating febuxostat therapy on or after 01 June 2016 will be observed.
Who may be able to join
- Index fill date on or after 01 June 2016.
- Having at least one diagnosis for gout (identified with diagnosis codes, International Classification of Diseases, clinical modification, ninth revision [ICD-9-CM]: 274.x or International Classification of Diseases, tenth revision [ICD-10]: M10.x) at any time in the participant's record.
- Continuously enrolled for at least 12 months prior to index fill date.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Utilization Study to Describe the Pattern of Febuxostat Use in Relationship to Allopurinol Following Addition of the Boxed Warning and Modification of the Indication Based on the Results of the CARES Trial
The prescribing information provides information on medicines. This study will check the number of patients starting febuxostat and the number of febuxostat users with cardiovascular disease after changes to the prescribing information.
Read the detailed description
This is a descriptive, cross-sectional, non-interventional study of participants with gout. The study will evaluate the impact of the 2019 labeling changes (boxed warning and modified indication), based upon results of the cardiovascular safety of febuxostat and allopurinol in participants with gout and cardiovascular morbidities (CARES) trial, on febuxostat utilization.
The study will evaluate data from approximately 24046 participants. The data will be collected from optum clinformatics dataMart (CDM) including the medicare advantage administrative US claims database and the IQVIA pharmetrics plus claims database.
All participants will be enrolled in a single observational cohort. This trial will be conducted in the United States. The overall duration of this study is approximately 14 months.
- Conditions
- Gout, Cardiovascular Diseases
- Medical subject headings
- Gout, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants With Gout | Participants with gout, initiating febuxostat therapy on or after 01 June 2016 will be included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Newly Initiating Febuxostat Therapy Versus Prevalent New Users
Participants will be categorized into new users and prevalent new users. New users are participants who were naïve to allopurinol, defined as no record of allopurinol use in all historic pharmacy or medical claims at any time prior to initiation of febuxostat. Prevalent new users are participants who had used allopurinol and switched, defined as at least one record of allopurinol use in all historic pharmacy or medical claims at any time prior to initiation of febuxostat.
Measured: Up to 14 months
Number of Participants With Established Cardiovascular Disease (CVD)
Participants initiating febuxostat will be categorized as having (Yes/No) to each of the following morbidities at any time prior to initiation of febuxostat: myocardial infarction (MI), unstable angina, stroke (hemorrhagic and ischemic), transient ischemic attack, peripheral vascular disease, diabetes mellitus with evidence of macrovascular or microvascular disease.
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start15 Aug 2020
- Primary completion5 Jan 2021
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 24,046 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853160
- Sponsor's protocol ID
- Febuxostat-5006
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization Study to Describe the Pattern of Febuxostat Use in Relationship to Allopurinol Following Addition of the Boxed Warning and Modification of the Indication Based on the Results of the CARES Trial
- ClinicalTrials.gov ID
- NCT04853160
- Acronym / sponsor ID
- Febuxostat-5006
- Conditions
- Gout, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,046 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 21 Apr 2021 (actual)
- 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 prescribing information provides information on medicines. This study will check the number of patients starting febuxostat and the number of febuxostat users with cardiovascular disease after changes to the prescribing information.
Detailed description
This is a descriptive, cross-sectional, non-interventional study of participants with gout. The study will evaluate the impact of the 2019 labeling changes (boxed warning and modified indication), based upon results of the cardiovascular safety of febuxostat and allopurinol in participants with gout and cardiovascular morbidities (CARES) trial, on febuxostat utilization.
The study will evaluate data from approximately 24046 participants. The data will be collected from optum clinformatics dataMart (CDM) including the medicare advantage administrative US claims database and the IQVIA pharmetrics plus claims database.
All participants will be enrolled in a single observational cohort. This trial will be conducted in the United States. The overall duration of this study is approximately 14 months.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants With Gout | – | –Participants with gout, initiating febuxostat therapy on or after 01 June 2016 will be included in the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with gout initiating febuxostat therapy on or after 01 June 2016 will be observed.
Key inclusion criteria (3 listed)
- Index fill date on or after 01 June 2016.
- Having at least one diagnosis for gout (identified with diagnosis codes, International Classification of Diseases, clinical modification, ninth revision [ICD-9-CM]: 274.x or International Classification of Diseases, tenth revision [ICD-10]: M10.x) at any time in the participant's record.
- Continuously enrolled for at least 12 months prior to index fill date.
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.
Primary outcome
Number of Participants Newly Initiating Febuxostat Therapy Versus Prevalent New Users
Time frame: Up to 14 months
Participants will be categorized into new users and prevalent new users. New users are participants who were naïve to allopurinol, defined as no record of allopurinol use in all historic pharmacy or medical claims at any time prior to initiation of febuxostat. Prevalent new users are participants who had used allopurinol and switched, defined as at least one record of allopurinol use in all historic pharmacy or medical claims at any time prior to initiation of febuxostat.
Number of Participants With Established Cardiovascular Disease (CVD)
Time frame: Up to 14 months
Participants initiating febuxostat will be categorized as having (Yes/No) to each of the following morbidities at any time prior to initiation of febuxostat: myocardial infarction (MI), unstable angina, stroke (hemorrhagic and ischemic), transient ischemic attack, peripheral vascular disease, diabetes mellitus with evidence of macrovascular or microvascular disease.
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 27 Apr 2021.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gout and Cardiovascular Diseases, run by Takeda at 1 site in United States.
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 3 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Participants Newly Initiating Febuxostat Therapy Versus Prevalent New Users (time frame: Up to 14 months). The study lists 2 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 27 Apr 2021.