An interventional study of DETECTRA and Standard of Care (SOC) in Rheumatoid Arthritis (RA, sponsored by Centre Hospitalier Universitaire Vaudois. Not yet recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Diagnostic
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:
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.
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 142 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 208 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Able to understand and interact with the study team
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard-of-care
Other: Standard of Care (SOC)
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
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.
Participants 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.
Time frame: From study enrollement to confirmed clinical diagnosis
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).
Time frame: From study enrollement until the end of the study (24months)
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).
Time frame: From study enrollement until the end of study (24months)
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.
Time frame: From study enrollement until the end of study (24months)
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.
Time frame: From enrolement until the end of study (24months).
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.
Time frame: From study enrollement until diagnosis or end of study (24months)
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.
Time frame: From enrolement until end of study (24months) or until diagnosis of RA.
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
Time frame: Full study duration (24months)
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).
Time frame: From study enrollement until the end of study
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.
Time frame: From study enrollement until the end of study (24months)
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.
Time frame: From study enrollement until end of study (24months)
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.
Time frame: From study enrollement until end of study (24months)
Plan to share: No
Start is estimated for Sep 2026; primary completion for Jul 2029, 34 months later.
Of 292 non-industry interventional studies with no phase under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 34 months is above that.
Counting every sponsor, half of 348 studies reached it within 27 months; a quarter within 13 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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