Rheumatoid Arthritis (RA
Conditions
Keywords
pre-RA, software as a medical device, time-to-diagnosis
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. 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.
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.
Interventions
DEVICEDETECTRA
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.
OTHERStandard of Care (SOC)
Participants receive standard rheumatology care only, with in-person visits and follow-up according to routine clinical practice.
Sponsors
Centre Hospitalier Universitaire Vaudois
Staatssekretariat für Bildung Forschung und Innovation SBFI
European Commission
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-diagnosis | From study enrollement to confirmed clinical 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in DAS28-CRP and SDAI | From study enrollement until the end of the study (24months) | 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). |
| Remission rates | From study enrollement until the end of study (24months) | 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). |
| Sensitivity | From study enrollement until the end of study (24months) | 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. |
| Specificity | From enrolement until the end of study (24months). | 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. |
| Adherence | From study enrollement until diagnosis or end of study (24months) | 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. |
| Cost-effectiveness estimates | Full study duration (24months) | 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 |
Countries
Austria, Denmark, Germany, Switzerland
Contacts
CONTACTThomas Hügle, Prof.
PRINCIPAL_INVESTIGATORThomas hügle, Prof.
Centre hospitalier universitaire vaudois (CHUV)
Outcome results
None listed