Rheumatic DisorderPix-MonitorNCT07857993
DETECTRA: Remote Monitoring to Detect Rheumatoid Arthritis Flares and Treatment Response
A study testing DETECTRA in people with Rheumatic Disorder and Rheumatoid Arthritis (RA), run by Centre Hospitalier Universitaire Vaudois at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatic Disorder, Rheumatoid Arthritis (RA)
- What is being tested?
- DETECTRA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Nov 2026to 30 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Germany2 sites
Charite Universitätsmedizin Berlin
Berlin
Arnd Kleyer, 004917620162789, arnd.kleyer@charite.de
arnd.kleyer@charite.de
Ruhr University Bochum
Bochum
Philipp Sewerin, philipp.sewerin@elisabethgruppe.de
Philipp Sewerin
Austria1 site
Medical University Vienna
Vienna
Peter Prof. Dr. Mandl, +43 1 40400 43010, peter.mandl@meduniwien.ac.at
Peter Mandl
About this study
Official title: 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:
Read more
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.
- Conditions
- Rheumatic Disorder, Rheumatoid Arthritis (RA)
- Being tested
- DETECTRA, Standard of Care (SOC)
- Keywords
- rheumatoid arthritis, remote monitoring, flare detection
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DETECTRADevice
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.
Standard of Care (SOC)Other
Standard of care for rheumatoid arthritis informed by EULAR guidelines.
| Study group | Role | What they receive |
|---|---|---|
| DETECTRA low disease activity (LDA) | Experimental | 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. Receives: Device: DETECTRA |
| DETECTRA high disease activity (HDA) | Experimental | 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. Receives: Device: DETECTRA |
| Standard of Care - low disease activity | Other | Inclusion criteria for being randomized within the LDA study:
• DAS28-CRP ≤ 2.6 Participants in this arm will receive the standard of care treatment. Receives: Other: Standard of Care (SOC) |
| Standard of Care - high disease activity | Other | 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. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to response to treatment detection
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.
Measured: From study enrollment to the end of study at 12months.
Time to flare detection
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
Measured: From enrollment to the end of study at 12months.
Secondary outcomes (14)
Diagnostic accuracy
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).
Measured: From study enrollment until end of study at 12months.
Sensitivity
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.
Measured: From study enrollment until end of study at 12months.
Specificity
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.
Measured: From enrollment until end of study at 12months.
Adherence
Percentage of submissions on the application (totally expected submissions = every week until end of trial) for patients in the DETECTRA intervention group.
Measured: From enrollment until the end of study at 12months.
Adherence
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.
Measured: From enrollment until the end of study at 12months.
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 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.
Measured: From enrollment until end of study at 12months.
Number of consultations
LDA group only:
Difference in number of consultations within the 12months study period in the DETECTRA group as compared to the standard group.
Measured: From enrollment until the end of study at 12months.
Difference in DAS28-CRP
After 12 months will be assessed by a trained rheumatologist in the DETECTRA group as compared to the standard group.
Measured: From enrollement until the end of study at 12months.
Difference in Simplified Disease Activity Index (SDAI)
Difference in SDAI after 12 months will be assessed by a trained rheumatologist in the DETECTRA group as compared to the standard group.
Measured: From enrollment until end of study at 12months.
Remission rates
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.
Measured: From enrollment until the end of study at 12months.
Sensitivity to change
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.
Measured: From enrollment until the end of study at 12months.
Patient empowerment
Regular self-reporting and feedback may increase perceived empowerment, trust in care, and shared decision-making (to be measured via PGIC).
Measured: From enrollment until the end of study at 12months.
Mental health & Quality of Life:
For diagnosed patients, reassurance from remote monitoring and reduced flare anxiety may improve mental health (measured via SF-36).
Measured: From enrollment until the end of study at 12months.
Usability and acceptance
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.
Measured: From enrollment until the end of study at 12months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Staatssekretariat für Bildung Forschung und Innovation SBFI, Horizon 2020 - European Commission
- Responsible party
- Principal investigator, Thomas Hügle, Centre Hospitalier Universitaire Vaudois
- Investigators
- Thomas hügle, Prof., Principal investigator, Centre hospitalier universitaire vaudois (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857993
- Sponsor's protocol ID
- Pix-Monitor
- Acronym
- Pix-Monitor
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40764087Konzett 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.
PubMed 37890977Morales-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.
PubMed 35840312Koller 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.
PubMed 42249051Finckh 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.
PubMed 17139662Raza 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.
PubMed 21821867Rosa 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.
PubMed 31609811Kernder 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.
PubMed 37258745Mucke 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.
PubMed 34966765Myasoedova 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.
PubMed 31526593Bernard 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.
PubMed 35248737Venerito 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.
PubMed 40256629Hugle 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.
PubMed 35949225Takase-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.
PubMed 28340066Lavezzari 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.
PubMed 26378777