DETECTRA: Remote Monitoring to Detect Rheumatoid Arthritis Flares and Treatment Response (Pix-Monitor)

September 29, 2026 updated by: Thomas Hügle, Centre Hospitalier Universitaire Vaudois

A Randomized, Four-Arm, Open-label, Standard-of-care Controlled, Multicentric Trial to Investigate the Efficacy of the Remote Monitoring Software DETECTRA to Detect and Shorten Time to Flare Detection and Treatment Response in Rheumatoid Arthritis.

The goal of this clinical trial is to learn if the DETECTRA remote monitoring platform can help clinicians detect rheumatoid arthritis (RA) disease flares earlier and more reliably, as well as identify response and non-response or insufficient response to treatment, compared with standard care. The study will include patients with RA and will follow them for 12 months.

The main questions it aims to answer are:

In patients with remission or low disease activity (DAS28-CRP ≤ 2.6), does remote monitoring with patient-reported outcomes and self-performed imaging using DETECTRA enable earlier detection of disease flares compared with standard care? In patients with higher disease activity (DAS28-CRP > 2.6) who have switched medication, does DETECTRA enable earlier and more reliable identification of response and non-response or insufficient response to treatment compared with standard care?

Researchers will compare the DETECTRA intervention groups with standard-of-care control groups to see whether remote monitoring enables earlier and more reliable detection of changes in disease activity and treatment response.

Participants will:

Be assigned to a Low Disease Activity (LDA) or High Disease Activity (HDA) substudy based on their DAS28-CRP score at baseline.

Be randomly assigned within their substudy to either the DETECTRA remote monitoring group or the standard-of-care group.

In the DETECTRA group, regularly provide patient-reported outcomes and perform self-imaging of their hands remotely using the DETECTRA application.

Attend standard clinical assessments and be followed for 12 months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥ 18 years and ≤ 80 years
  • Diagnosed with RA according to the EULAR 2010 criteria
  • Affection of at least one hand joint in the past (synovitis, tenderness, dactylitis, tenosynovitis)
  • 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

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 in the past 2 years
  • Lymphoedema in arms or hands following an axillary lymph node dissection
  • Immunosuppressive therapy for other autoimmune conditions <2 years ago
  • Immunosuppressive therapy for other autoimmune conditions with B-cell depletion <5 years ago
  • Haematological or oncological treatments involving induction and / or maintenance chemotherapy <5 years
  • Aged >80 years
  • 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
  • Inability to provide written informed consent
  • Severe cognitive impairment, severe psychiatric conditions or other inability to follow the procedures of the study
  • No regular access (weekly) 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 > 27 days)
  • Enrolment of the PI, his/her family members, employees and other dependent persons
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DETECTRA low disease activity (LDA)

Inclusion criteria for being randomized within the LDA study:

• DAS28-CRP ≤ 2.6 Participants in this group will receive standard of care treatment and in addittion receive the DETECTRA application which they will use on a weekly basis during 12months.
Device: DETECTRA

DETECTRA is a mobile application to be used on a weekly basis by patients where they submit hand images as well as report patient reported outcomes.
Experimental: DETECTRA high disease activity (HDA)

Inclusion criteria for being randomized withing the HDA study:

  • DAS28-CRP > 2.6
  • A change or start of any DMARDs treatment Participants in this arm will receive standard of care treatment and in addition will use the DETECTRA app on a weekly basis for 12months.
Device: DETECTRA

DETECTRA is a mobile application to be used on a weekly basis by patients where they submit hand images as well as report patient reported outcomes.
Other: Standard of Care - low disease activity

Inclusion criteria for being randomized within the LDA study:

• DAS28-CRP ≤ 2.6 Participants in this arm will receive the standard of care treatment.
Other: Standard of Care (SOC)

Standard of care for rheumatoid arthritis informed by EULAR guidelines.
Other: Standard of Care - high disease activity

Inclusion criteria for being randomized withing the HDA study:

  • DAS28-CRP > 2.6
  • A change or start of any DMARDs treatment Particiapnts in this arm will receive standard of care treatment.
Other: Standard of Care (SOC)

Standard of care for rheumatoid arthritis informed by EULAR guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to response to treatment detection
Time Frame: From study enrollment to the end of study at 12months.

HDA groups:

•Time in (days) from study enrolment to response to treatment detection in RA (defined as DAS28 change of > 0.6 between 2 visits / CDAI improvement ≥ 6 points to baseline at 3 months and current CDAI remaining ≤ 10 points) comparing the DETECTRA group to the standard care group.
From study enrollment to the end of study at 12months.
Time to flare detection
Time Frame: From enrollment to the end of study at 12months.

LDA groups: •Time (in days) from study enrolment to confirmed flare (defined as Change of Clinical Disease Activity Index (CDAI) ≥ 4.5 points from last visit & current CDAI > 10 or change of DAS28-CRP > 1.2 and the current DAS28 ≥ 2.6) and
From enrollment to the end of study at 12months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: From study enrollment until end of study at 12months.

Diagnostic accuracy of the DETECTRA system to differentiate between presence and absence of a flare / non-response / insufficient response to treatment (as defined by clinical examination) will be assessed using the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
From study enrollment until end of study at 12months.
Sensitivity
Time Frame: From study enrollment until end of study at 12months.

Missed flares/non-response / insufficient response to treatment 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 any visit. Any confirmed flare is classified as a missed flare if a patients request a visit (or in a planned visits) without that the physician had previously recognized signs via the dashboard of a potential flare.
From study enrollment until end of study at 12months.
Specificity
Time Frame: From enrollment until end of study at 12months.

False flares/detection of non-response / insufficient response to treatment in the intervention group will be assessed at any interim visit and is reported if a patient got flagged via the dashboard, came in for confirmation but does not get confirmation of a flare or of a non-response / insufficient response to treatment.
From enrollment until end of study at 12months.
Adherence
Time Frame: From enrollment until the end of study at 12months.

Percentage of submissions on the application (totally expected submissions = every week until end of trial) for patients in the DETECTRA intervention group.
From enrollment until the end of study at 12months.
Adherence
Time Frame: From enrollment until the end of study at 12months.

Average amount of reminders (calls by the study nurse but not the automatic reminders via the app) per patient needed during the duration of the study (1year). For participants in the DETECTRA arms.
From enrollment until the end of study at 12months.
Cost-effectiveness estimates
Time Frame: From enrollment until end of study at 12months.

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 and changes. These trial-derived endpoints, particularly time-to-flare detection and amount of visits, will inform a Markov model to extrapolate long-term costs and outcomes beyond the trial period.
From enrollment until end of study at 12months.
Number of consultations
Time Frame: From enrollment until the end of study at 12months.

LDA group only:

Difference in number of consultations within the 12months study period in the DETECTRA group as compared to the standard group.
From enrollment until the end of study at 12months.
Difference in DAS28-CRP
Time Frame: From enrollement until the end of study at 12months.

After 12 months will be assessed by a trained rheumatologist in the DETECTRA group as compared to the standard group.
From enrollement until the end of study at 12months.
Difference in Simplified Disease Activity Index (SDAI)
Time Frame: From enrollment until end of study at 12months.

Difference in SDAI after 12 months will be assessed by a trained rheumatologist in the DETECTRA group as compared to the standard group.
From enrollment until end of study at 12months.
Remission rates
Time Frame: From enrollment until the end of study at 12months.

Percentage of patients in remission after 12 months, will be assessed by a trained rheumatologist in the DETECTRA group as compared to the standard group.
From enrollment until the end of study at 12months.
Sensitivity to change
Time Frame: From enrollment until the end of study at 12months.

Sensitivity to change will be calculated for the 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.
From enrollment until the end of study at 12months.
Patient empowerment
Time Frame: From enrollment until the end of study at 12months.

Regular self-reporting and feedback may increase perceived empowerment, trust in care, and shared decision-making (to be measured via PGIC).
From enrollment until the end of study at 12months.
Mental health & Quality of Life:
Time Frame: From enrollment until the end of study at 12months.

For diagnosed patients, reassurance from remote monitoring and reduced flare anxiety may improve mental health (measured via SF-36).
From enrollment until the end of study at 12months.
Usability and acceptance
Time Frame: From enrollment until the end of study at 12months.

This will be measured with the System Usability Scale (SUS) at the end of the trial within patients and HCPs who were using the app or the dashboard during the trial.
From enrollment until the end of study at 12months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory validation of additional imaging-derived metrics (e.g., finger joint geometry, patterns, motility)
Time Frame: From enrollment until the end of study at 12months.

Images and videos from any time-point of the investigation taken via the DETECTRA system will be used to support future enhancements of DETECTRA and the algorithms of the system.
From enrollment until the end of study at 12months.
Diagnostic accuracy FFI
Time Frame: From enrollment until the end of study at 12months.

Diagnostic accuracy of the FFI 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).
From enrollment until the end of study at 12months.
Thermal imaging dataset construction
Time Frame: From enrollment until the end of study at 12months.

• Data completeness: The number of valid thermal images successfully linked with their corresponding comprehensive set of clinical, demographic, laboratory, and ultrasound reference data.
From enrollment until the end of study at 12months.
Thermal imaging
Time Frame: From enrollment until the end of study at 12months.

Data quality: Assessment of image technical quality (e.g., image noise, hand position, absence of artifacts) to ensure suitability for future image processing.
From enrollment until the end of study at 12months.
Thermal imaging
Time Frame: From enrollment until the end of study at 12months.

Dataset integrity: The successful compilation of a structured dataset suitable for the development and validation of artificial intelligence models
From enrollment until the end of study at 12months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Collaborators

Horizon 2020 - European Commission
Staatssekretariat für Bildung Forschung und Innovation SBFI

Investigators

  • Principal Investigator: Thomas hügle, Prof., Centre hospitalier universitaire vaudois (CHUV)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

September 22, 2026

First Submitted That Met QC Criteria

September 29, 2026

First Posted (Actual)

October 5, 2026

Study Record Updates

Last Update Posted (Actual)

October 5, 2026

Last Update Submitted That Met QC Criteria

September 29, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pix-Monitor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe