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Psoriatic ArthritisPDPIDNCT06347237

PsA Digital Phenotyping and Inflammation Drivers Study

An observational study of Psoriatic Arthritis and Flare Up, Symptom, run by Jolanda Luime.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this observational study is to develop and internally validate a machine learning model for detecting flare using a digital biomarker and a machine learning model for predicting flare, in patients with psoriatic arthritis. Read more about this study

Who is it for?
Ages 18 years and older
How many people
600 participants
Where
No sites listed yet
Study dates
May 2024to Dec 2025
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: Patients with psoriatic arthritis

Who may be able to join

  • Diagnosed with PsA
  • Age 18 years or older and competent
  • Using a smartphone
  • Agree to use smartwatch
  • Good command of the local language

Who cannot join

  • Less than 18 years of age
  • Incapacitated

About this study

The goal of this observational study is to develop and internally validate a machine learning model for detecting flare using a digital biomarker and a machine learning model for predicting flare, in patients with psoriatic arthritis. The main questions it aims to answer are:

  • In patients with psoriatic arthritis, is a digital biomarker capable of detecting a flare as compared to clinical defined flare by the rheumatologist?
  • In patients with psoriatic arthritis, what factors trigger a psoriatic arthritis flare ?

Participants will be requested to:

  • Install app on their phone
  • Use a smartwatch
  • Complete questionnaires
  • Collect biological material
Keywords
psoriatic arthritis, inflammation, digital biomarker, flare
Medical subject headings
Arthritis, Psoriatic, Symptom Flare Up, Inflammation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absence of flare in patients

    Flare in psoriatic arthritis evaluated as:

    Patients

    • 'At this time, is your psoriatic arthritis in remission, if this means: you feel your disease is as good as gone?' yes/ no (for remission)
    • 'At this time, are you in low disease activity, if this means: your disease is in low activity but it's not as good as gone?' yes/ no (for low disease activity)

    Patient Acceptable Symptom State

    • 'If you were to remain for the next few months as you were during the last 48 hours, would this be acceptable or unacceptable for you?' yes/ no

    Doctors

    • 'At this time, is the psoriatic arthritis in remission, if this means: the absence of clinical and laboratory evidence of significant inflammatory disease activity?' yes/ no (for remission)
    • 'At this time, is the psoriatic arthritis in low or minimal disease activity?' yes/ no (for low disease activity)

    Measured: 12 months (follow-up every 3 months)

Secondary outcomes (5)

  1. Minimal disease Activity (MDA)

    MDA as defined by patient meeting 5 out of 7 of the following criteria: (i) tender joint count ≤1; (ii) swollen joint count ≤1; (iii) Psoriasis Area and Severity Index ≤ 1 or body surface area ≤3%; (iv) tender entheseal points ≤ 1 (v) patient pain visual analogue scale VAS ≤15; (vi) patient global activity VAS ≤20; (vii) Health Assessment Questionnaire (HAQ) ≤0.5

    Measured: 12 months (follow-up every 3 months)

  2. Psoriatic Arthritis Disease Activity Score (PASDAS)

    PASDAS calculated as a composite score using the following criteria: physician global VAS, patient global VAS, SF36 physical (PCS), swollen joint count, tender joint count, Leeds Enthesitis Index, tender dactylitis count, and CRP. Higher scores indicate higher disease activity.

    Measured: 12 months (follow-up every 3 months)

  3. Disease Activity Psoriatic Arthritis (DAPSA)

    DAPSA calculated as a summation score of the following: tender and swollen joints, patient global assessment VAS, patient pain VAS and C-reactive protein. Higher scores indicate higher disease activity.

    Measured: 12 months (follow-up every 3 months)

  4. Psoriatic Arthritis Impact of Disease (PsAID)

    PsAID:10-point Likert scale questions on 12 items (pain, fatigue, skin, work/leisure activities, functional capacity, discomfort, sleep, coping, anxiety, embarrassment, social life, depression). Higher score indicates higher impact of disease.

    Measured: 12 months (follow-up every 3 months)

  5. Morning stiffness

    Morning stiffness on a 10-point Likert scale. Higher scores indicate higher morning stiffness.

    Measured: 12 months (follow-up every 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study startMay 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06347237
Sponsor's protocol ID
NL84429.078.23
Acronym
PDPID
Status last verified
Apr 2024
First submitted
14 Feb 2024
Last updated
4 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hojeij B, Tchetverikov I, Vasileiou E, Apostolidis G, Dimitroulas T, Mytilinaiou M, Goncalves C, Rodrigues AM, Coates L, Konstantinidis D, Dimitropoulos K, Melanitis N, Foolen J, Wagenaar W, Charisis V, Hadjileontiadis LJ, Luime JJ. Psoriatic arthritis digital phenotyping and inflammation drivers (PDPID) study: protocol for an international multicentre prospective cohort. BMJ Open. 2026 Sep 28;16(9):e115903. doi: 10.1136/bmjopen-2025-115903.

    PubMed 42805667

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriatic Arthritis and Flare Up, Symptom, run by Jolanda Luime.

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 2 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 4 Apr 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?

Results are not available in the source record.

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?

Absence of flare in patients (time frame: 12 months (follow-up every 3 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06347237, which also lists 1 linked publication.

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 4 Apr 2024.

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