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

NCT07825233 | Not Yet Recruiting DMC

• 2 other identifiers: 2026-D0063101194766
• Study Type: interventional
• Target: 142
• Locations: 4 countries
• Sites: 5

Brief 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. The main questions it aims to answer are: 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. 1.Receive standard medical care
2. 2.Receive standard medical care and use the DETECTRA application

Conditions

Rheumatoid Arthritis (RA

Keywords

pre-RA; software as a medical device; time-to-diagnosis

Outcome Measures

Primary Outcomes (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.

  From study enrollement to confirmed clinical diagnosis

Secondary Outcomes (7)

• Difference in DAS28-CRP and SDAI

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

• Remission rates

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

• Sensitivity

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

• Specificity

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

• Adherence

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

Other Outcomes (4)

• Diagnostic accuracy

  From study enrollement until the end of study

• Sensitivity to change

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

• Exploratory analysis of additional imaging-derived metrics

  From study enrollement until end of study (24months)

Study Arms (2)

Control group

OTHER

Standard-of-care

Other: Standard of Care (SOC)

DETECTRA

EXPERIMENTAL

The 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.

Device: DETECTRA

Interventions

DETECTRA DEVICE

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.

DETECTRA

Standard of Care (SOC) OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• Staatssekretariat für Bildung Forschung und Innovation SBFI: collaborator
• European Commission: collaborator

Study Sites (5)

Medical University Vienna

Vienna, Austria

Location

Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet

Copenhagen, Denmark

Location

Charite Universitätsmedizin Berlin

Berlin, Germany

Location

Ruhr University Bochum

Bochum, Germany

Location

Centre Hospitalier Unversitaire Vaudois

Lausanne, 1011, Switzerland

Location

Related Publications (24)

• 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.

  PMID: 40764087 BACKGROUND

• 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.

  PMID: 12784382 BACKGROUND

• 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.

  PMID: 17139662 BACKGROUND

• 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.

  PMID: 21821867 BACKGROUND

• 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.

  PMID: 31609811 BACKGROUND

• 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.

  PMID: 37258745 BACKGROUND

• 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.

  PMID: 35840312 BACKGROUND

• 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.

  PMID: 39001284 BACKGROUND

• 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.

  PMID: 39903294 BACKGROUND

• 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.

  PMID: 39874236 BACKGROUND

• 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.

  PMID: 36642438 BACKGROUND

• 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.

  PMID: 35949225 BACKGROUND

• 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.

  PMID: 35273981 BACKGROUND

• 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.

  PMID: 30527425 BACKGROUND

• 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.

  PMID: 27342772 BACKGROUND

• van Steenbergen HW, Aletaha D, Beaart-van de Voorde LJ, Brouwer E, Codreanu C, Combe B, Fonseca JE, Hetland ML, Humby F, Kvien TK, Niedermann K, Nuno L, Oliver S, Rantapaa-Dahlqvist S, Raza K, van Schaardenburg D, Schett G, De Smet L, Szucs G, Vencovsky J, Wiland P, de Wit M, Landewe RL, van der Helm-van Mil AH. EULAR definition of arthralgia suspicious for progression to rheumatoid arthritis. Ann Rheum Dis. 2017 Mar;76(3):491-496. doi: 10.1136/annrheumdis-2016-209846. Epub 2016 Oct 6.

  PMID: 27991858 BACKGROUND

• Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.

  PMID: 20872595 BACKGROUND

• Zhao SS, Duffield SJ, Goodson NJ. The prevalence and impact of comorbid fibromyalgia in inflammatory arthritis. Best Pract Res Clin Rheumatol. 2019 Jun;33(3):101423. doi: 10.1016/j.berh.2019.06.005. Epub 2019 Jul 17.

  PMID: 31703796 BACKGROUND

• Bernard L, Valsecchi V, Mura T, Aouinti S, Padern G, Ferreira R, Pastor J, Jorgensen C, Mercier G, Pers YM. Management of patients with rheumatoid arthritis by telemedicine: connected monitoring. A randomized controlled trial. Joint Bone Spine. 2022 Oct;89(5):105368. doi: 10.1016/j.jbspin.2022.105368. Epub 2022 Mar 4.

  PMID: 35248737 BACKGROUND

• Skovsgaard CV, Kruse M, Hjollund N, Maribo T, de Thurah A. Cost-effectiveness of a telehealth intervention in rheumatoid arthritis: economic evaluation of the Telehealth in RA (TeRA) randomized controlled trial. Scand J Rheumatol. 2023 Mar;52(2):118-128. doi: 10.1080/03009742.2021.2008604. Epub 2022 Jan 20.

  PMID: 35048793 BACKGROUND

• Song Y, Bernard L, Jorgensen C, Dusfour G, Pers YM. The Challenges of Telemedicine in Rheumatology. Front Med (Lausanne). 2021 Oct 13;8:746219. doi: 10.3389/fmed.2021.746219. eCollection 2021.

  PMID: 34722584 BACKGROUND

• Krijbolder DI, Verstappen M, van Dijk BT, Dakkak YJ, Burgers LE, Boer AC, Park YJ, de Witt-Luth ME, Visser K, Kok MR, Molenaar ETH, de Jong PHP, Bohringer S, Huizinga TWJ, Allaart CF, Niemantsverdriet E, van der Helm-van Mil AHM. Intervention with methotrexate in patients with arthralgia at risk of rheumatoid arthritis to reduce the development of persistent arthritis and its disease burden (TREAT EARLIER): a randomised, double-blind, placebo-controlled, proof-of-concept trial. Lancet. 2022 Jul 23;400(10348):283-294. doi: 10.1016/S0140-6736(22)01193-X.

  PMID: 35871815 BACKGROUND

• Finckh A, Gilbert B, Hodkinson B, Bae SC, Thomas R, Deane KD, Alpizar-Rodriguez D, Lauper K. Global epidemiology of rheumatoid arthritis. Nat Rev Rheumatol. 2022 Oct;18(10):591-602. doi: 10.1038/s41584-022-00827-y. Epub 2022 Sep 6.

  PMID: 36068354 BACKGROUND

• Rech J, Tascilar K, Hagen M, Kleyer A, Manger B, Schoenau V, Hueber AJ, Kleinert S, Baraliakos X, Braun J, Kiltz U, Fleck M, Rubbert-Roth A, Kofler DM, Behrens F, Feuchtenberger M, Zaenker M, Voll R, Venhoff N, Thiel J, Glaser C, Feist E, Burmester GR, Karberg K, Strunk J, Canete JD, Senolt L, Filkova M, Naredo E, Largo R, Kronke G, D'Agostino MA, Ostergaard M, Schett G. Abatacept inhibits inflammation and onset of rheumatoid arthritis in individuals at high risk (ARIAA): a randomised, international, multicentre, double-blind, placebo-controlled trial. Lancet. 2024 Mar 2;403(10429):850-859. doi: 10.1016/S0140-6736(23)02650-8. Epub 2024 Feb 13.

  PMID: 38364841 BACKGROUND

Related Links

• The funding for this trial comes from AutoPiX consortium. AutoPiX is a European project of the type 'Innovative Heath Initiative Joint Undertaking - JU-IHI' under the European framework programme HORIZON and funded by the European Commission (ref. 101194

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas hügle, Prof.

  Centre hospitalier universitaire vaudois (CHUV)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Hügle, Prof.

CONTACT

+41795568068; thomas.hugle@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Thomas Hügle - Head of departement

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 17, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); DE (2); DK (1); AU (1)