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Rheumatoid Arthritis (RAPix-RiskNCT07825233

Pix-Risk: Early Detection of Rheumatoid Arthritis Via the DETECTRA Platform

A study testing DETECTRA in people with Rheumatoid Arthritis (RA, run by Centre Hospitalier Universitaire Vaudois at 5 sites in 4 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn if a remote monitoring application called DETECTRA can help doctors diagnose rheumatoid arthritis earlier in people who are at risk of developing the disease. It will also learn about the safety and usefulness of this approach. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis (RA
What is being tested?
DETECTRA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
5 sitesin 4 countries
Study dates
28 Sep 2026to 31 Jul 2029
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must provide and sign the study's Informed Consent prior to any study-related procedures
  • Able to understand and interact with the study team
  • Agree to comply in good faith with all conditions of the recordings, and to attend all required study procedures.
  • Arthralgia (including hand joints PIP and or MCP)
  • Joint symptoms (arthralgia or stiffness) of recent onset (symptoms <1 year)
  • Known positive ACPA-titer with written proof
  • Aged 18 years-old or more

Who cannot join

  • Deformation of the hands or patients who have undergone joint arthrodesis or arthroplasty
  • Known microcrystal disease (e.g. gout, calcium pyrophosphate deposition) if hands are affected or pre-existing immune-mediated rheumatic diseases such as systemic lupus erythematosus or Sjögren's disease
  • Fulfilling the ACR/EULAR 2010 classification criteria for diagnosis of RA (≥ 6 points)
  • Known or suspected clinical synovitis by physician in > 3 small joints (with or without involvement of large joints)
  • Any previous b, ts, and csDMARDs use
  • Lymphoedema in arms or hands following an axillary lymph node dissection
Show all 16Show fewer
  • Inability to provide written informed consent
  • Severe cognitive impairment, severe psychiatric conditions or other inability to follow the procedures of the study
  • Immunosuppressive therapy for other autoimmune conditions <2 years ago
  • Any Immunosuppressive therapy for other autoimmune conditions with B-cell depletion
  • Haematological or oncological treatments involving induction and / or maintenance chemotherapy within the last 5 years are not permitted
  • Participation in another investigation with an investigational drug or another MD within the 30 days preceding the trial or currently participating or planning to participate in an interventional trial
  • No regular (at least every 2 weeks) access to a smartphone
  • Adults who lack capacity to consent, known pregnant and breastfeeding women
  • Subjects for whom routine examination of the musculoskeletal system is not possible, or whose hands cannot be imaged (e.g., bandages that cannot be removed for hand picture taking, or injuries affecting the PIP joints both persisting for > 49 days)
  • Enrolment of the PI, his/her family members, employees and other dependent persons

Trial locations and contacts

5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Thomas Hügle, Prof. contact

+41795568068

thomas.hugle@chuv.ch

5 sites in 4 countries

Germany2 sites

  • Charite Universitätsmedizin Berlin

    Berlin

    Arnd Kleyer, arnd.kleyer@charite.de

    arnd.kleyer@charite.de

  • Ruhr University Bochum

    Bochum

    Philipp Sewerin, philipp.sewerin@elisabethgruppe.de

Other trials in Germany

Austria1 site

  • Medical University Vienna

    Vienna

    Irina Gessl, Dr., +43 1 40400 43010, irina.gessl@meduniwien.ac.at

Other trials in Austria

Denmark1 site

  • Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet

    Copenhagen

    Lene Terslev

    Lene Terslev, Prof.

Other trials in Denmark

Switzerland1 site

  • Centre Hospitalier Unversitaire Vaudois

    Lausanne, 1011

    Thomas Hügle, Prof., +41795568068, thomas.hugle@chuv.ch

    Thomas hügle, Prof.

Other trials in Switzerland

About this study

Official title: A Randomised, Two-arm, Parallel-assigned Open-label Standard-of-care Controlled Trial to Investigate the Efficacy of Using the Remote Patient Monitoring Platform DETECTRA to Shorten Time-to-diagnosis of Rheumatoid Arthritis in At-risk Patients.

The goal of this clinical trial is to learn if a remote monitoring application called DETECTRA can help doctors diagnose rheumatoid arthritis earlier in people who are at risk of developing the disease. It will also learn about the safety and usefulness of this approach.

The main questions it aims to answer are:

Read more

Does monitoring symptoms through the DETECTRA application help doctors diagnose rheumatoid arthritis earlier than standard medical follow-up? Does the use of the application help doctors identify signs of arthritis and arrange a medical consultation sooner? How does the disease progress in participants, and how well are their symptoms controlled?

A total of 142 adults will take part in the study. Participants will be randomly assigned to one of two groups:

  1. Receive standard medical care
  2. Receive standard medical care and use the DETECTRA application

Participants using the application will:

Answer questions about their symptoms every 2 weeks Take photographs of their hands using their smartphone Have their information reviewed remotely by doctors

The study will also look at how participants use the application and whether remote monitoring could be useful for the healthcare system.

Read the detailed description

The Pix-Risk study is an international clinical trial investigating whether a remote monitoring application called DETECTRA can help diagnose rheumatoid arthritis earlier in people who are at risk of developing the disease. These patients have recently developed joint pain and have a positive blood test indicating an increased risk, but they have not yet been diagnosed with the disease.

A total of 142 adults will participate in the study. They will be randomly assigned to two groups: one group will receive standard medical care, while the other will have access to the DETECTRA application in addition to standard care. Every two weeks, participants using the application will be asked to answer a few questions about their symptoms and take photographs of their hands using their smartphone. Doctors will be able to review this information remotely to identify signs of arthritis at an earlier stage and arrange a consultation if necessary.

The main objective is to determine whether this digital monitoring approach allows rheumatoid arthritis to be diagnosed more quickly than standard follow-up. The researchers will also assess disease progression, symptom control, use of the application, and its potential benefits for the healthcare system.

The study involves minimal risks, as it primarily relies on questionnaires, photographs, and routine medical examinations. The aim is to improve the early detection of the disease so that treatment can be started earlier and joint damage can be reduced.

Being tested
DETECTRA, Standard of Care (SOC)
Keywords
pre-RA, software as a medical device, time-to-diagnosis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DETECTRADevice

    Intervention arm (DETECTRA):

    Participants receive standard of care plus use of the DETECTRA remote monitoring app. Every two weeks, patients capture hand images and report symptoms via smartphone. Data are reviewed remotely by clinicians to support early detection of rheumatoid arthritis. The intervention is non-invasive, software-based, and continues up to 24 months or until diagnosis.

  • Standard of Care (SOC)Other

    Participants receive standard rheumatology care only, with in-person visits and follow-up according to routine clinical practice.

Study groups in NCT07825233
Study groupRoleWhat they receive
Control groupOtherStandard-of-care
Receives: Other: Standard of Care (SOC)
DETECTRAExperimentalThe intervention group will receive the DETECTRA application on top of the standard-of-care and will use it every two weeks to upload hand images and report patient reported outcomes.
Receives: Device: DETECTRA

What is being measured

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

  1. Time-to-diagnosis

    Time (in days) from study enrollment to confirmed clinical diagnosis of rheumatoid arthritis (with the ACR/EULAR 2010 classification criteria for RA (≥ 6 points) and / or physician diagnosis with start of DMARDs) in ACPA-positive arthralgia patients, comparing the DETECTRA group to the standard-of-care group.

    Measured: From study enrollement to confirmed clinical diagnosis

Secondary outcomes (7)

  1. Difference in DAS28-CRP and SDAI

    Difference in DAS28-CRP and SDAI after 24 months will be assessed by a trained rheumatologist in the DETECTRA group as compared to the standard-of-care group (only in RA confirmed patients).

    Measured: From study enrollement until the end of the study (24months)

  2. Remission rates

    Percentage of patients in remission after 24 months will be assessed by a trained rheumatologist in the DETECTRA group as compared to the standard-of-care group (only in RA confirmed patients).

    Measured: From study enrollement until the end of study (24months)

  3. Sensitivity

    Sensitivity: Missed onsets/diagnosis of clinical arthritis in the intervention group: This endpoint will be assessed if a patient comes for a visit based on his request and in the closure visit. Any confirmed RA is classified as a missed diagnosis if patients request a visit (or in the planned closure visit) and are diagnosed without that the physician had previously recognized signs via the platform of a potential onset of RA.

    Measured: From study enrollement until the end of study (24months)

  4. Specificity

    Specificity: False diagnoses in the intervention group will be assessed at any interim visit and is reported if a patient got flagged via the platform, came in for confirmation but does not get diagnosed.

    Measured: From enrolement until the end of study (24months).

  5. Adherence

    Percentage of submissions on the platform (totally expected submissions = every two weeks until diagnosis or end of trial) per patient during the duration of the study (2 years). Only for patients in the intervention group.

    Measured: From study enrollement until diagnosis or end of study (24months)

  6. Adherence

    Average amount of reminders (calls by the study nurse but not the automatic reminders via the app) per patient needed for the duration of the study (2 years). Only for participants in the intervention group.

    Measured: From enrolement until end of study (24months) or until diagnosis of RA.

  7. Cost-effectiveness estimates

    The primary outcome of interest for the health economic evaluation is cost-effectiveness, expressed as the incremental cost per Quality-Adjusted Life Year (QALY) gained through the use of DETECTRA compared to standard-of-care. Data for the evaluation will be collected from both the DETECTRA system and clinical records during the trial. Through the app, patients will report PROs including self-assessed joint counts (tender and swollen), global pain and stiffness scores (via VAS-like scales), medication use, free-text symptom notes, and joint-specific pain reports. At the clinic level, data will be collected on the timing and number of visits, formal RA diagnoses, and DMARD treatment initiations. These trial-derived endpoints-particularly time-to-diagnosis, time to DMARD start, and proportion diagnosed within defined timeframes-will inform a Markov model to extrapolate long-term costs and outcomes beyond the trial period. QALYs will be estimated using available health state information

    Measured: Full study duration (24months)

Timeline

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

  1. First posted17 Sep 2026
  2. Study start28 Sep 2026 (estimated)
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07825233
Sponsor's protocol ID
2026-D0063
Other IDs
101194766
Acronym
Pix-Risk
Status last verified
Sep 2026
First submitted
5 Sep 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Frederiksen BA, Hammer HB, Terslev L, Ammitzboll-Danielsen M, Savarimuthu TR, Weber ABH, Just SA. Automated ultrasound system ARTHUR V.2.0 with AI analysis DIANA V.2.0 matches expert rheumatologist in hand joint assessment of rheumatoid arthritis patients. RMD Open. 2025 Aug 5;11(3):e005805. doi: 10.1136/rmdopen-2025-005805.

    PubMed 40764087

  • Sokka T, Pincus T. Most patients receiving routine care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or american college of rheumatology criteria for remission. J Rheumatol. 2003 Jun;30(6):1138-46.

    PubMed 12784382

  • Finckh A, Liang MH, van Herckenrode CM, de Pablo P. Long-term impact of early treatment on radiographic progression in rheumatoid arthritis: A meta-analysis. Arthritis Rheum. 2006 Dec 15;55(6):864-72. doi: 10.1002/art.22353.

    PubMed 17139662

  • Raza K, Stack R, Kumar K, Filer A, Detert J, Bastian H, Burmester GR, Sidiropoulos P, Kteniadaki E, Repa A, Saxne T, Turesson C, Mann H, Vencovsky J, Catrina A, Chatzidionysiou A, Hensvold A, Rantapaa-Dahlqvist S, Binder A, Machold K, Kwiatkowska B, Ciurea A, Tamborrini G, Kyburz D, Buckley CD. Delays in assessment of patients with rheumatoid arthritis: variations across Europe. Ann Rheum Dis. 2011 Oct;70(10):1822-5. doi: 10.1136/ard.2011.151902. Epub 2011 Aug 7.

    PubMed 21821867

  • Rosa JE, Garcia MV, Luissi A, Pierini F, Sabelli M, Mollerach F, Soriano ER. Rheumatoid Arthritis Patient's Journey: Delay in Diagnosis and Treatment. J Clin Rheumatol. 2020 Oct;26(7S Suppl 2):S148-S152. doi: 10.1097/RHU.0000000000001196.

    PubMed 31609811

  • Kernder A, Thiele K, Chehab G, Schneider M, Callhoff J. Time interval between the onset of connective tissue disease symptoms and first contact with a rheumatologist: results from the German National Database of collaborative arthritis centers. Rheumatol Int. 2023 Aug;43(8):1453-1458. doi: 10.1007/s00296-023-05335-0. Epub 2023 Jun 1.

    PubMed 37258745

  • Morales-Ivorra I, Narvaez J, Gomez-Vaquero C, Moragues C, Nolla JM, Narvaez JA, Marin-Lopez MA. Assessment of inflammation in patients with rheumatoid arthritis using thermography and machine learning: a fast and automated technique. RMD Open. 2022 Jul;8(2):e002458. doi: 10.1136/rmdopen-2022-002458.

    PubMed 35840312

  • Morales-Ivorra I, Taverner D, Codina O, Castell S, Fischer P, Onken D, Martinez-Osuna P, Battioui C, Marin-Lopez MA. External Validation of the Machine Learning-Based Thermographic Indices for Rheumatoid Arthritis: A Prospective Longitudinal Study. Diagnostics (Basel). 2024 Jun 30;14(13):1394. doi: 10.3390/diagnostics14131394.

    PubMed 39001284

  • Pfeuffer N, Hartmann F, Grahammer M, Simon D, Schuster L, Kuhn S, Kronke G, Schett G, Knitza J, Kleyer A. Early detection of rheumatoid arthritis through patient empowerment by tailored digital monitoring and education: a feasibility study. Rheumatol Int. 2025 Feb 4;45(2):43. doi: 10.1007/s00296-025-05793-8.

    PubMed 39903294

  • van Mulligen E, Bour SS, Goossens LMA, de Jong PHP, Rutten-van Molken M, van der Helm-van Mil A. Is a 1-year course of methotrexate in patients with arthralgia at-risk for rheumatoid arthritis cost-effective? A cost-effectiveness analysis of the randomised, placebo-controlled TREAT EARLIER trial. Ann Rheum Dis. 2025 Jan;84(1):68-76. doi: 10.1136/ard-2024-226286. Epub 2025 Jan 2.

    PubMed 39874236

  • Barber CEH, Lacaille D, Croxford R, Barnabe C, Marshall DA, Abrahamowicz M, Xie H, Avina-Zubieta JA, Esdaile JM, Hazlewood GS, Faris P, Katz S, MacMullan P, Mosher D, Widdifield J. Investigating Associations Between Access to Rheumatology Care, Treatment, Continuous Care, and Healthcare Utilization and Costs Among Older Individuals With Rheumatoid Arthritis. J Rheumatol. 2023 May;50(5):617-624. doi: 10.3899/jrheum.220729. Epub 2023 Jan 15.

    PubMed 36642438

  • Hugle T, Caratsch L, Caorsi M, Maglione J, Dan D, Dumusc A, Blanchard M, Kalweit G, Kalweit M. Dorsal Finger Fold Recognition by Convolutional Neural Networks for the Detection and Monitoring of Joint Swelling in Patients with Rheumatoid Arthritis. Digit Biomark. 2022 Jun 8;6(2):31-35. doi: 10.1159/000525061. eCollection 2022 May-Aug.

    PubMed 35949225

  • Studenic P, Hensvold A, Kleyer A, van der Helm-van Mil A, Pratt AG, Sieghart D, Kronke G, Williams R, de Souza S, Karlfeldt S, Johannesson M, Krogh NS, Klareskog L, Catrina AI. Prospective Studies on the Risk of Rheumatoid Arthritis: The European Risk RA Registry. Front Med (Lausanne). 2022 Feb 22;9:824501. doi: 10.3389/fmed.2022.824501. eCollection 2022.

    PubMed 35273981

  • van der Woude D, van der Helm-van Mil AHM. Update on the epidemiology, risk factors, and disease outcomes of rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2018 Apr;32(2):174-187. doi: 10.1016/j.berh.2018.10.005. Epub 2018 Nov 16.

    PubMed 30527425

  • Kleyer A, Krieter M, Oliveira I, Faustini F, Simon D, Kaemmerer N, Cavalcante A, Tabosa T, Rech J, Hueber A, Schett G. High prevalence of tenosynovial inflammation before onset of rheumatoid arthritis and its link to progression to RA-A combined MRI/CT study. Semin Arthritis Rheum. 2016 Oct;46(2):143-150. doi: 10.1016/j.semarthrit.2016.05.002. Epub 2016 May 18.

    PubMed 27342772

Questions about this trial

What is this clinical trial studying?

A study testing DETECTRA in people with Rheumatoid Arthritis (RA, run by Centre Hospitalier Universitaire Vaudois at 5 sites in 4 countries.

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 7 inclusion and 16 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Austria, Denmark, Switzerland. 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?

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 Thomas Hügle, Prof. (+41795568068, thomas.hugle@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-diagnosis (time frame: From study enrollement to confirmed clinical diagnosis). 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 NCT07825233, which also lists 24 linked publications.

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 17 Sep 2026.

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