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.
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)
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)
Parallel
DETECTRA
DeviceIntervention 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 interventionParticipants receive standard rheumatology care only, with in-person visits and follow-up according to routine clinical practice.
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.
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).
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).
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.
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.
Diagnostic accuracy
Diagnostic accuracy of the Finger Fold Index to differentiate between presence and absence of synovitis (as defined by clinical examination and or ultrasound) will be assessed using the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Sensitivity to change
Sensitivity to change will be calculated for each biomarker (FFI) using the Standardized Response Mean (SRM), defined as the mean change from baseline to follow-up divided by the standard deviation of the change scores. The correlation between the SRMs of CRP will then be evaluated to assess whether their responsiveness to change is related.
Exploratory analysis of additional imaging-derived metrics
Images from any time-point of the investigation taken via the DETECTRA system will be used to support future enhancements of the algorithms/biomarkers (FFI) integrated in the DETECTRA system. The predefined FFI implementation used within this clinical investigation is fixed and will not be modified during the study. Exploratory analyses will not influence device outputs, clinical assessments, or study endpoints. Any findings may be used to inform future biomarker development and algorithm refinement in subsequent device versions outside the scope of this investigation.
Thermal imaging dataset
The outcome of interest regarding thermal imaging is the successful creation of the thermographic dataset. This includes: * Data completeness: The number of valid thermal images successfully linked with their corresponding comprehensive set of clinical, demographic, laboratory, and ultrasound reference data. * Data quality: Assessment of image technical quality (e.g., image noise, hand position, absence of artifacts) to ensure suitability for future image processing. * Repository integrity: The successful compilation of a structured database ready for transfer to Singularity Biomed.
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Centre Hospitalier Universitaire Vaudois
Lead sponsor
Staatssekretariat für Bildung Forschung und Innovation SBFI
Collaborator
European Commission
Collaborator
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