Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07825233

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

Sponsor: Centre Hospitalier Universitaire Vaudois

View on ClinicalTrials.gov

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. 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.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2026-09-28

Completion Date

2029-07-31

Last Updated

2026-09-17

Healthy Volunteers

Conditions

Rheumatoid Arthritis (RA

Interventions

DEVICE

DETECTRA

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.

OTHER

Standard of Care (SOC)

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Enrolment of the PI, his/her family members, employees and other dependent persons

Locations (5)

Medical University Vienna

Vienna, Austria

Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet

Copenhagen, Denmark

Charite Universitätsmedizin Berlin

Berlin, Germany

Ruhr University Bochum

Bochum, Germany

Centre Hospitalier Unversitaire Vaudois

Lausanne, Switzerland