Psoriatic ArthritisIDBVNCT07594054
Inflammation Digital Biomarkers Validation Study
An observational study of Psoriatic Arthritis and Psoriasis (PsO), run by University of Oxford.
Trial summary
HIPPOCRATES is an Innovative Medicines Initiative (IMI) funded EU Consortium established to address key unmet clinical needs in psoriatic disease. As part of the project, the HIPPOCRATES Prospective Observational Study (HPOS) is a study of patients with psoriasis which is recruiting across Europe. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriatic Arthritis, Psoriasis (PsO)
- How many people
- 3,458 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults with a diagnosis of psoriasis and without psoriatic arthritis currently enrolled in the HPOS study.
Who may be able to join
- Previously consented to take part in the HPOS study and have agreed to be contacted for future ethically approved studies.
- Adults with psoriasis with no diagnosis of PsA.
- Have a compatible smartphone
- Have a good command of local language
Who cannot join
- Participants not consented into the HPOS study
- Do not have use of a compatible smartphone
- Are not willing to use the smartphone app.
- Adults with a pre-existing diagnosis of PsA
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Study contact contact
About this study
Official title: IDBV: Inflammation Digital Biomarker Validation Study
HIPPOCRATES is an Innovative Medicines Initiative (IMI) funded EU Consortium established to address key unmet clinical needs in psoriatic disease. As part of the project, the HIPPOCRATES Prospective Observational Study (HPOS) is a study of patients with psoriasis which is recruiting across Europe. The study is led by a research team at University of Oxford and supported by a team at University College Dublin. This current study aims to identify people with psoriasis who are at risk of developing psoriatic arthritis. Up to one-third of patients with psoriasis will develop a related arthritis causing inflammation in the joints and tendons. The investigators want to identify which patients will develop arthritis with the long-term and ambitious aim of trying to prevent the development of arthritis before it occurs. The HPOS study is currently recruiting/approaching adults with psoriasis and asking study participants to complete questionnaires every 6 months via a dedicated study website. The questionnaires include a 'screening questionnaire' to try to identify arthritis.
Adults with psoriasis but without a pre-existing diagnosis of PsA are currently being recruited via clinics, national and international patient support organisations including those under the umbrella of EUROPSO, and media campaigns. Participants are recruited across Europe in the following countries: UK, Ireland, Italy, France, Spain, Denmark, Germany, Belgium, Netherlands, Sweden, Portugal, Greece, Norway, Switzerland, Poland and Romania. The University of Oxford is the sponsor for the study across all countries, but local regulations will be followed, and local ethical approval has been sought for each different country. Data is requested from participants every 6 months and they will be prompted by email.
Read more
Likewise, the iPROLEPSIS consortium is a Horizon Europe funded consortium investigating digital biomarkers in PsA. In 2024, the consortium launched a study recruiting 600 patients with PsA across 4 counties, utilising digital biomarkers to identify disease flares. This includes the use of smartwatches, a mobile phone app and active video tests. This will allow us to develop algorithms to identify active disease.
Similar approaches are proposed for a study called the Inflammation Digital Biomarkers Study (IDBV) which will try to identify the onset of PsA in people living with psoriasis. Patients in HPOS who have given consent to be contacted about additional studies, will be offered the opportunity to join this study. They will complete an additional consent form and will download the miPROLEPSIS lite app to their mobile phone.
The Study app will passively collect data from the user's phone; participants do not need to perform any specific tasks apart from some initial configuration steps like logging in and connecting their wearables (Connecting a wearable is optional).
The investigators intend to run IDBV as a sub-study in HPOS and invite participants enrolled into the HPOS study who do not have a diagnosis of PsA.
- Conditions
- Psoriatic Arthritis, Psoriasis (PsO)
- Medical subject headings
- Arthritis, Psoriatic, Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of IMID-Specific Joint or Tendon Inflammation
Presence of inflammation to evaluate the performance of smartphone-/smartwatch-based AI-driven digital biomarkers and predictive models (developed in PDPID study) in the detection of Immune Mediated Inflammatory Disease (IMID) specific joint or tendon inflammation
Measured: From enrolment for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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 of OxfordThe 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
- Prospective
- Enrolment
- 3,458 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, University College Dublin, Aristotle University Of Thessaloniki, NOVA Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594054
- Sponsor's protocol ID
- 367594
- Acronym
- IDBV
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDBV: Inflammation Digital Biomarker Validation Study
- ClinicalTrials.gov ID
- NCT07594054
- Acronym / sponsor ID
- IDBV / 367594
- Conditions
- Psoriatic Arthritis, Psoriasis (PsO)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,458 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, University College Dublin, Aristotle University Of Thessaloniki, NOVA Medical School
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 May 2026 (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.
HIPPOCRATES is an Innovative Medicines Initiative (IMI) funded EU Consortium established to address key unmet clinical needs in psoriatic disease. As part of the project, the HIPPOCRATES Prospective Observational Study (HPOS) is a study of patients with psoriasis which is recruiting across Europe. The study is led by a research team at University of Oxford and supported by a team at University College Dublin. This current study aims to identify people with psoriasis who are at risk of developing psoriatic arthritis. Up to one-third of patients with psoriasis will develop a related arthritis causing inflammation in the joints and tendons. The investigators want to identify which patients will develop arthritis with the long-term and ambitious aim of trying to prevent the development of arthritis before it occurs. The HPOS study is currently recruiting/approaching adults with psoriasis and asking study participants to complete questionnaires every 6 months via a dedicated study website. The questionnaires include a 'screening questionnaire' to try to identify arthritis.
Adults with psoriasis but without a pre-existing diagnosis of PsA are currently being recruited via clinics, national and international patient support organisations including those under the umbrella of EUROPSO, and media campaigns. Participants are recruited across Europe in the following countries: UK, Ireland, Italy, France, Spain, Denmark, Germany, Belgium, Netherlands, Sweden, Portugal, Greece, Norway, Switzerland, Poland and Romania. The University of Oxford is the sponsor for the study across all countries, but local regulations will be followed, and local ethical approval has been sought for each different country. Data is requested from participants every 6 months and they will be prompted by email.
Likewise, the iPROLEPSIS consortium is a Horizon Europe funded consortium investigating digital biomarkers in PsA. In 2024, the consortium launched a study recruiting 600 patients with PsA across 4 counties, utilising digital biomarkers to identify disease flares. This includes the use of smartwatches, a mobile phone app and active video tests. This will allow us to develop algorithms to identify active disease.
Similar approaches are proposed for a study called the Inflammation Digital Biomarkers Study (IDBV) which will try to identify the onset of PsA in people living with psoriasis. Patients in HPOS who have given consent to be contacted about additional studies, will be offered the opportunity to join this study. They will complete an additional consent form and will download the miPROLEPSIS lite app to their mobile phone.
The Study app will passively collect data from the user's phone; participants do not need to perform any specific tasks apart from some initial configuration steps like logging in and connecting their wearables (Connecting a wearable is optional).
The investigators intend to run IDBV as a sub-study in HPOS and invite participants enrolled into the HPOS study who do not have a diagnosis of PsA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with a diagnosis of psoriasis and without psoriatic arthritis currently enrolled in the HPOS study.
Key inclusion criteria (4 listed)
- Previously consented to take part in the HPOS study and have agreed to be contacted for future ethically approved studies.
- Adults with psoriasis with no diagnosis of PsA.
- Have a compatible smartphone
- Have a good command of local language
Key exclusion criteria (4 listed)
- Participants not consented into the HPOS study
- Do not have use of a compatible smartphone
- Are not willing to use the smartphone app.
- Adults with a pre-existing diagnosis of PsA
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
Presence of IMID-Specific Joint or Tendon Inflammation
Time frame: From enrolment for 12 months
Presence of inflammation to evaluate the performance of smartphone-/smartwatch-based AI-driven digital biomarkers and predictive models (developed in PDPID study) in the detection of Immune Mediated Inflammatory Disease (IMID) specific joint or tendon inflammation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- iPROLEPSIS websiteLink provided by the sponsor.
- HIPPOCRATES websiteLink 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.
Study contact contact
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis and Psoriasis (PsO), run by University of Oxford.
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 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: opening soon, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura C Coates (+441865737838, laura.coates@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of IMID-Specific Joint or Tendon Inflammation (time frame: From enrolment for 12 months). 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 22 May 2026.