DETECTRA: Remote Monitoring to Detect Rheumatoid Arthritis Flares and Treatment Response (Pix-Monitor)
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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Thomas Hügle, Prof.
- Номер телефона: +41795568068
- Электронная почта: thomas.hugle@chuv.ch
Места учебы
-
-
-
Vienna, Австрия
- Medical University Vienna
-
Контакт:
- Peter Prof. Dr. Mandl
- Номер телефона: +43 1 40400 43010
- Электронная почта: peter.mandl@meduniwien.ac.at
-
Главный следователь:
- Peter Mandl
-
-
-
-
-
Berlin, Германия
- Charite Universitätsmedizin Berlin
-
Контакт:
- Электронная почта: arnd.kleyer@charite.de
-
Главный следователь:
- arnd Kleyer
-
Контакт:
- Arnd Kleyer
- Номер телефона: 004917620162789
- Электронная почта: arnd.kleyer@charite.de
-
Bochum, Германия
- Ruhr University Bochum
-
Контакт:
- Philipp Sewerin
- Электронная почта: philipp.sewerin@elisabethgruppe.de
-
Главный следователь:
- Philipp Sewerin
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
|
Экспериментальный: DETECTRA high disease activity (HDA)
Inclusion criteria for being randomized withing the HDA study:
|
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. |
|
Другой: 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. |
|
Другой: Standard of Care - high disease activity
Inclusion criteria for being randomized withing the HDA study:
|
Standard of care for rheumatoid arthritis informed by EULAR guidelines. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time to response to treatment detection
Временное ограничение: 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
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Diagnostic accuracy
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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:
Временное ограничение: 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
Временное ограничение: 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.
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Exploratory validation of additional imaging-derived metrics (e.g., finger joint geometry, patterns, motility)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Thomas hügle, Prof., Centre hospitalier universitaire vaudois (CHUV)
Публикации и полезные ссылки
Общие публикации
- Frederiksen BA, Hammer HB, Terslev L, Ammitzboll-Danielsen M, Savarimuthu TR, Weber ABH, Just SA. Automated ultrasound system ARTHUR V.2.0 with AI analysis DIANA V.2.0 matches expert rheumatologist in hand joint assessment of rheumatoid arthritis patients. RMD Open. 2025 Aug 5;11(3):e005805. doi: 10.1136/rmdopen-2025-005805.
- Finckh A, Liang MH, van Herckenrode CM, de Pablo P. Long-term impact of early treatment on radiographic progression in rheumatoid arthritis: A meta-analysis. Arthritis Rheum. 2006 Dec 15;55(6):864-72. doi: 10.1002/art.22353.
- Raza K, Stack R, Kumar K, Filer A, Detert J, Bastian H, Burmester GR, Sidiropoulos P, Kteniadaki E, Repa A, Saxne T, Turesson C, Mann H, Vencovsky J, Catrina A, Chatzidionysiou A, Hensvold A, Rantapaa-Dahlqvist S, Binder A, Machold K, Kwiatkowska B, Ciurea A, Tamborrini G, Kyburz D, Buckley CD. Delays in assessment of patients with rheumatoid arthritis: variations across Europe. Ann Rheum Dis. 2011 Oct;70(10):1822-5. doi: 10.1136/ard.2011.151902. Epub 2011 Aug 7.
- Rosa JE, Garcia MV, Luissi A, Pierini F, Sabelli M, Mollerach F, Soriano ER. Rheumatoid Arthritis Patient's Journey: Delay in Diagnosis and Treatment. J Clin Rheumatol. 2020 Oct;26(7S Suppl 2):S148-S152. doi: 10.1097/RHU.0000000000001196.
- Kernder A, Thiele K, Chehab G, Schneider M, Callhoff J. Time interval between the onset of connective tissue disease symptoms and first contact with a rheumatologist: results from the German National Database of collaborative arthritis centers. Rheumatol Int. 2023 Aug;43(8):1453-1458. doi: 10.1007/s00296-023-05335-0. Epub 2023 Jun 1.
- Morales-Ivorra I, Narvaez J, Gomez-Vaquero C, Moragues C, Nolla JM, Narvaez JA, Marin-Lopez MA. Assessment of inflammation in patients with rheumatoid arthritis using thermography and machine learning: a fast and automated technique. RMD Open. 2022 Jul;8(2):e002458. doi: 10.1136/rmdopen-2022-002458.
- Hugle T, Caratsch L, Caorsi M, Maglione J, Dan D, Dumusc A, Blanchard M, Kalweit G, Kalweit M. Dorsal Finger Fold Recognition by Convolutional Neural Networks for the Detection and Monitoring of Joint Swelling in Patients with Rheumatoid Arthritis. Digit Biomark. 2022 Jun 8;6(2):31-35. doi: 10.1159/000525061. eCollection 2022 May-Aug.
- Bernard L, Valsecchi V, Mura T, Aouinti S, Padern G, Ferreira R, Pastor J, Jorgensen C, Mercier G, Pers YM. Management of patients with rheumatoid arthritis by telemedicine: connected monitoring. A randomized controlled trial. Joint Bone Spine. 2022 Oct;89(5):105368. doi: 10.1016/j.jbspin.2022.105368. Epub 2022 Mar 4.
- Konzett V, Kerschbaumer A, Smolen JS, Kristianslund EK, Provan SA, Kvien TK, Aletaha D. Definition of rheumatoid arthritis flare based on SDAI and CDAI. Ann Rheum Dis. 2024 Jan 11;83(2):169-176. doi: 10.1136/ard-2023-224742.
- Koller C, Maglione J, Blanchard M, Kleyer A, Folle L, Geurts J, Hugle T. Clinical investigation of a digital biomarker for joint swelling in inflammatory arthritis based on automated quantification of dorsal finger fold patterns. Sci Rep. 2026 Jun 6;16(1):24727. doi: 10.1038/s41598-026-56797-8.
- Mucke J, Knitza J, Muehlensiepen F, Grahammer M, Stenzel R, Simon D, Kleyer A, Kronke G, Sharp C, Bendzuck G, Korinth M, Elling-Audersch C, Vuillerme N, Schett G, Pecher AC, Krusche M. TELERA-Asynchronous TELEmedicine for Patients With Rheumatoid Arthritis: Study Protocol for a Prospective, Multi-Center, Randomized Controlled Trial. Front Med (Lausanne). 2021 Dec 13;8:791715. doi: 10.3389/fmed.2021.791715. eCollection 2021.
- Myasoedova E, De Thurah A, Erpelding ML, Schneeberger EE, Maribo T, Citera G, Davis JM, Matteson EL, Crowson CS, Fautrel B, Guillemin F. Definition and construct validation of clinically relevant cutoffs on the Flare Assessment in Rheumatoid Arthritis (FLARE-RA) questionnaire. Semin Arthritis Rheum. 2020 Apr;50(2):261-265. doi: 10.1016/j.semarthrit.2019.09.004. Epub 2019 Sep 11.
- Venerito V, Manigold T, Capodiferro M, Markham D, Blanchard M, Iannone F, Hugle T. Single-camera motion capture of finger joint mobility as a digital biomarker for disease activity in rheumatoid arthritis. Rheumatol Adv Pract. 2025 Apr 18;9(2):rkae143. doi: 10.1093/rap/rkae143. eCollection 2025.
- Takase-Minegishi K, Horita N, Kobayashi K, Yoshimi R, Kirino Y, Ohno S, Kaneko T, Nakajima H, Wakefield RJ, Emery P. Diagnostic test accuracy of ultrasound for synovitis in rheumatoid arthritis: systematic review and meta-analysis. Rheumatology (Oxford). 2018 Jan 1;57(1):49-58. doi: 10.1093/rheumatology/kex036.
- Lavezzari G, Womack AW. Industry perspectives on biomarker qualification. Clin Pharmacol Ther. 2016 Feb;99(2):208-13. doi: 10.1002/cpt.264. Epub 2015 Oct 22.
- Orr CK, Najm A, Young F, McGarry T, Biniecka M, Fearon U, Veale DJ. The Utility and Limitations of CRP, ESR and DAS28-CRP in Appraising Disease Activity in Rheumatoid Arthritis. Front Med (Lausanne). 2018 Aug 3;5:185. doi: 10.3389/fmed.2018.00185. eCollection 2018.
- Atzeni F, Masala IF, di Franco M, Sarzi-Puttini P. Infections in rheumatoid arthritis. Curr Opin Rheumatol. 2017 Jul;29(4):323-330. doi: 10.1097/BOR.0000000000000389.
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания опорно-двигательного аппарата
- Артрит
- Заболевания суставов
- Ревматические заболевания
- Заболевания соединительной ткани
- Аутоиммунные заболевания
- Заболевания иммунной системы
- Заболевания кожи и соединительной ткани
- Артрит, Ревматоидный
- Администрация медицинских услуг
- Качество, доступ и оценка здравоохранения
- Качество здравоохранения
- Индикаторы качества, здравоохранение
- Стандарт ухода
Другие идентификационные номера исследования
- Pix-Monitor
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .