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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.
Sponsor study identifier
interventional
320
2 countries
3
Study Start
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2026
Actual (reported)October 5, 2026
Actual (reported)November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
From enrollment to the end of study at 12months.
Diagnostic accuracy
From study enrollment until end of study at 12months.
Sensitivity
From study enrollment until end of study at 12months.
Specificity
From enrollment until end of study at 12months.
Adherence
From enrollment until the end of study at 12months.
Adherence
From enrollment until the end of study at 12months.
Exploratory validation of additional imaging-derived metrics (e.g., finger joint geometry, patterns, motility)
From enrollment until the end of study at 12months.
Diagnostic accuracy FFI
From enrollment until the end of study at 12months.
Thermal imaging dataset construction
From enrollment until the end of study at 12months.
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.
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.
Standard of care for rheumatoid arthritis informed by EULAR guidelines.
Medical University Vienna
Vienna, Austria
Charite Universitätsmedizin Berlin
Berlin, Germany
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.
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.
Thomas hügle, Prof.
Centre hospitalier universitaire vaudois (CHUV)
First Submitted
September 22, 2026
First Posted
October 5, 2026
Study Start
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 30, 2028
Inclusion criteria for being randomized within the LDA study: • DAS28-CRP ≤ 2.6 Participants in this arm will receive the standard of care treatment.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Ruhr University Bochum
Bochum, Germany
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.
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.
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.
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.
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.
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.
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.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 5, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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