Psoriatic ArthritisPsoriaticNCT06125444
Impact of Hyperuricemia on Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Psoriatic arthritis and gout (linked to hyperuricemia) are two rheumatisms well known to rheumatologists. There are epidemiological and physiopathological arguments in favor of a non-fortuitous link between these two rheumatisms, which to date has not been established. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 242 participants
- Where
- 1 siteFrance
- Study dates
- 24 Aug 2020to 31 Dec 2023
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subject (≥18 years old), with a history of psoriatic arthritis objectified according to the CIM 10-1 coding for patients followed in hospitalization at the HUS and HCC and subject presenting psoriatic arthritis objectified during a consultation by an HCC rheumatologist
Who may be able to join
- Major subject (≥18 years old)
- Subject with a history of psoriatic arthritis objectified according to the CIM 10-1 coding for patients followed in hospitalization at the HUS and HCC
- Subject presenting psoriatic arthritis objectified during a consultation by an HCC rheumatologist
- Among these two populations, all subjects for whom at least one serum uric acid assay was available in the medical file
- Subject having not expressed, after being informed, opposition to the reuse of their data for research purposes
Who cannot join
- Subject who expressed their opposition to participating in the study
- Subject who met the inclusion criteria but whose analysis of the medical file (anamnestic, clinical, biological and radiological data) led to a diagnostic reversal and therefore did not present with psoriatic arthritis
- Subject under guardianship or curatorship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Rhumatologie - CHU de Strasbourg - France
Strasbourg, 67091
Renaud FELTEN, MD, PhD, 33 3 88 12 79 64, renaud.felten@chru-strasbourg.fr
Renaud FELTEN, MD
About this study
Official title: IImpact of Hyperuricemia on Psoriatic Arthritis
Psoriatic arthritis and gout (linked to hyperuricemia) are two rheumatisms well known to rheumatologists. There are epidemiological and physiopathological arguments in favor of a non-fortuitous link between these two rheumatisms, which to date has not been established. There is currently no recommendation to treat hyperuricaemia without an episode of gout attack. We hypothesize that there is a link between hyperuricemia and severity of rheumatism. This would ultimately modify the therapeutic management of hyperuricemic patients followed for psoriatic arthritis.
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, Hyperuricemia, Rheumatisms
- Medical subject headings
- Arthritis, Psoriatic, Hyperuricemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospectively determine the impact of hyperuricemia on the response to psoriatic arthritis treatments: inventory of the latest treatments in progress and the response to treatment according to the treating rheumatologist
Measured: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start24 Aug 2020
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125444
- Sponsor's protocol ID
- 7957
- Acronym
- Psoriatic
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2022
- Last updated
- 8 Dec 2023
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IImpact of Hyperuricemia on Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT06125444
- Acronym / sponsor ID
- Psoriatic / 7957
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, Hyperuricemia, Rheumatisms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Nov 2023 (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.
Psoriatic arthritis and gout (linked to hyperuricemia) are two rheumatisms well known to rheumatologists. There are epidemiological and physiopathological arguments in favor of a non-fortuitous link between these two rheumatisms, which to date has not been established. There is currently no recommendation to treat hyperuricaemia without an episode of gout attack. We hypothesize that there is a link between hyperuricemia and severity of rheumatism. This would ultimately modify the therapeutic management of hyperuricemic patients followed for psoriatic arthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years old), with a history of psoriatic arthritis objectified according to the CIM 10-1 coding for patients followed in hospitalization at the HUS and HCC and subject presenting psoriatic arthritis objectified during a consultation by an HCC rheumatologist
Key inclusion criteria (5 listed)
- Major subject (≥18 years old)
- Subject with a history of psoriatic arthritis objectified according to the CIM 10-1 coding for patients followed in hospitalization at the HUS and HCC
- Subject presenting psoriatic arthritis objectified during a consultation by an HCC rheumatologist
- Among these two populations, all subjects for whom at least one serum uric acid assay was available in the medical file
- Subject having not expressed, after being informed, opposition to the reuse of their data for research purposes
Key exclusion criteria (4 listed)
- Subject who expressed their opposition to participating in the study
- Subject who met the inclusion criteria but whose analysis of the medical file (anamnestic, clinical, biological and radiological data) led to a diagnostic reversal and therefore did not present with psoriatic arthritis
- Subject under guardianship or curatorship
- Subject under safeguard of justice
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
Retrospectively determine the impact of hyperuricemia on the response to psoriatic arthritis treatments: inventory of the latest treatments in progress and the response to treatment according to the treating rheumatologist
Time frame: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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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.
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 Psoriatic Arthritis, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renaud FELTEN, MD (33 3 88 12 79 64, renaud.felten@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospectively determine the impact of hyperuricemia on the response to psoriatic arthritis treatments: inventory of the latest treatments in progress and the response to treatment according to the treating rheumatologist (time frame: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined). 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 8 Dec 2023.