NCT Number: NCT07825233
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Medical University Vienna, Vienna, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrolement until end of study (24months) or until diagnosis of RA.
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: 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
Time frame: From study enrollement until the end of study
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 (24months)
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 end of study (24months)
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)
The outcome of interest regarding thermal imaging is the successful creation of the thermographic dataset. This includes:
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire Vaudois
Other
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.
Acronym: Pix-Risk
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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