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

29. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

320

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.

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.

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.

Sonstiges: 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.

Standard of care for rheumatoid arthritis informed by EULAR guidelines.

Sonstiges: 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.

Standard of care for rheumatoid arthritis informed by EULAR guidelines.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to response to treatment detection
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Diagnostic accuracy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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:
Zeitfenster: 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
Zeitfenster: 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.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Exploratory validation of additional imaging-derived metrics (e.g., finger joint geometry, patterns, motility)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mitarbeiter

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. November 2026

Primärer Abschluss (Geschätzt)

30. Dezember 2028

Studienabschluss (Geschätzt)

30. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

22. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. September 2026

Zuerst gepostet (Tatsächlich)

5. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • Pix-Monitor

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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