[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658907":3},{"organization":4,"outcomesModule":7,"designInfo":78,"detailedDescription":81,"studyPopulation":81,"armGroups":85,"interventions":105,"overallOfficials":115,"centralContacts":120,"locations":126,"responsibleParty":176,"collaborators":179,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":187,"sex":193,"minAge":194,"maxAge":195,"enrollmentInfo":196,"targetDuration":81,"studyType":199,"phases":200,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":210,"whyStopped":81,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":63},[9,13],{"measure":10,"description":11,"timeFrame":12},"Time to response to treatment detection","HDA groups:\n\n•Time in (days) from study enrolment to response to treatment detection in RA (defined as DAS28 change of \\> 0.6 between 2 visits \u002F 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.",{"measure":14,"description":15,"timeFrame":16},"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.",[18,22,25,29,33,35,38,41,45,48,51,54,57,60],{"measure":19,"description":20,"timeFrame":21},"Diagnostic accuracy","Diagnostic accuracy of the DETECTRA system to differentiate between presence and absence of a flare \u002F non-response \u002F 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.",{"measure":23,"description":24,"timeFrame":21},"Sensitivity","Missed flares\u002Fnon-response \u002F 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.",{"measure":26,"description":27,"timeFrame":28},"Specificity","False flares\u002Fdetection of non-response \u002F 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 \u002F insufficient response to treatment.","From enrollment until end of study at 12months.",{"measure":30,"description":31,"timeFrame":32},"Adherence","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.",{"measure":30,"description":34,"timeFrame":32},"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.",{"measure":36,"description":37,"timeFrame":28},"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.",{"measure":39,"description":40,"timeFrame":32},"Number of consultations","LDA group only:\n\nDifference in number of consultations within the 12months study period in the DETECTRA group as compared to the standard group.",{"measure":42,"description":43,"timeFrame":44},"Difference in DAS28-CRP","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.",{"measure":46,"description":47,"timeFrame":28},"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.",{"measure":49,"description":50,"timeFrame":32},"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.",{"measure":52,"description":53,"timeFrame":32},"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.",{"measure":55,"description":56,"timeFrame":32},"Patient empowerment","Regular self-reporting and feedback may increase perceived empowerment, trust in care, and shared decision-making (to be measured via PGIC).",{"measure":58,"description":59,"timeFrame":32},"Mental health & Quality of Life:","For diagnosed patients, reassurance from remote monitoring and reduced flare anxiety may improve mental health (measured via SF-36).",{"measure":61,"description":62,"timeFrame":32},"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.",[64,67,70,73,76],{"measure":65,"description":66,"timeFrame":32},"Exploratory validation of additional imaging-derived metrics (e.g., finger joint geometry, patterns, motility)","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.",{"measure":68,"description":69,"timeFrame":32},"Diagnostic accuracy FFI","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).",{"measure":71,"description":72,"timeFrame":32},"Thermal imaging dataset construction","• Data completeness: The number of valid thermal images successfully linked with their corresponding comprehensive set of clinical, demographic, laboratory, and ultrasound reference data.",{"measure":74,"description":75,"timeFrame":32},"Thermal imaging","Data quality: Assessment of image technical quality (e.g., image noise, hand position, absence of artifacts) to ensure suitability for future image processing.",{"measure":74,"description":77,"timeFrame":32},"Dataset integrity: The successful compilation of a structured dataset suitable for the development and validation of artificial intelligence models",{"allocation":79,"interventionModel":80,"interventionModelDescription":81,"primaryPurpose":82,"observationalModel":81,"timePerspective":81,"maskingInfo":83},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":84,"maskingDescription":81,"whoMasked":81},"NONE",[86,92,96,101],{"label":87,"type":88,"description":89,"interventionNames":90},"DETECTRA low disease activity (LDA)","EXPERIMENTAL","Inclusion criteria for being randomized within the LDA study:\n\n• 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.",[91],"Device: DETECTRA",{"label":93,"type":88,"description":94,"interventionNames":95},"DETECTRA high disease activity (HDA)","Inclusion criteria for being randomized withing the HDA study:\n\n* DAS28-CRP \\> 2.6\n* 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.",[91],{"label":97,"type":6,"description":98,"interventionNames":99},"Standard of Care - low disease activity","Inclusion criteria for being randomized within the LDA study:\n\n• DAS28-CRP ≤ 2.6 Participants in this arm will receive the standard of care treatment.",[100],"Other: Standard of Care (SOC)",{"label":102,"type":6,"description":103,"interventionNames":104},"Standard of Care - high disease activity","Inclusion criteria for being randomized withing the HDA study:\n\n* DAS28-CRP \\> 2.6\n* A change or start of any DMARDs treatment Particiapnts in this arm will receive standard of care treatment.",[100],[106,111],{"type":107,"name":108,"description":109,"armGroupLabels":110,"otherNames":81},"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.",[93,87],{"type":6,"name":112,"description":113,"armGroupLabels":114,"otherNames":81},"Standard of Care (SOC)","Standard of care for rheumatoid arthritis informed by EULAR guidelines.",[102,97],[116],{"name":117,"affiliation":118,"role":119},"Thomas hügle, Prof.","Centre hospitalier universitaire vaudois (CHUV)","PRINCIPAL_INVESTIGATOR",[121],{"name":122,"role":123,"phone":124,"phoneExt":81,"email":125},"Thomas Hügle, Prof.","CONTACT","+41795568068","thomas.hugle@chuv.ch",[127,145,163],{"facility":128,"status":81,"city":129,"state":81,"zip":81,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":137,"contacts":138},"Medical University Vienna","Vienna","Austria","AT",{"type":133,"coordinates":134},"Point",[135,136],16.37208,48.20849,{"lat":136,"lon":135},[139,143],{"name":140,"role":123,"phone":141,"phoneExt":81,"email":142},"Peter Prof. Dr. Mandl","+43 1 40400 43010","peter.mandl@meduniwien.ac.at",{"name":144,"role":119,"phone":81,"phoneExt":81,"email":81},"Peter Mandl",{"facility":146,"status":81,"city":147,"state":81,"zip":81,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Charite Universitätsmedizin Berlin","Berlin","Germany","DE",{"type":133,"coordinates":151},[152,153],13.41053,52.52437,{"lat":153,"lon":152},[156,160,161],{"name":157,"role":123,"phone":158,"phoneExt":81,"email":159},"Arnd Kleyer","004917620162789","arnd.kleyer@charite.de",{"name":81,"role":123,"phone":81,"phoneExt":81,"email":159},{"name":162,"role":119,"phone":81,"phoneExt":81,"email":81},"arnd Kleyer",{"facility":164,"status":81,"city":165,"state":81,"zip":81,"country":148,"countryCode":149,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Ruhr University Bochum","Bochum",{"type":133,"coordinates":167},[168,169],7.21648,51.48165,{"lat":169,"lon":168},[172,175],{"name":173,"role":123,"phone":81,"phoneExt":81,"email":174},"Philipp Sewerin","philipp.sewerin@elisabethgruppe.de",{"name":173,"role":119,"phone":81,"phoneExt":81,"email":81},{"type":119,"investigatorFullName":177,"investigatorTitle":178,"investigatorAffiliation":5,"oldNameTitle":81,"oldOrganization":81},"Thomas Hügle","Prof. Dr. Thomas Hügle - Head of departement",[180,183],{"name":181,"class":182},"Staatssekretariat für Bildung Forschung und Innovation SBFI","UNKNOWN",{"name":184,"class":6},"Horizon 2020 - European Commission","100658907","detectra-remote-monitoring-to-detect-rheumatoid-arthritis-flares-and-treatment-response-100658907",false,"NCT07857993","DETECTRA: Remote Monitoring to Detect Rheumatoid Arthritis Flares and Treatment Response","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.","Pix-Monitor","Inclusion Criteria:\n\n* Aged ≥ 18 years and ≤ 80 years\n* Diagnosed with RA according to the EULAR 2010 criteria\n* Affection of at least one hand joint in the past (synovitis, tenderness, dactylitis, tenosynovitis)\n* Must provide and sign the study's Informed Consent prior to any study-related procedures;\n* Able to understand and interact with the study team\n* Agree to comply in good faith with all conditions of the recordings, and to attend all required study procedures\n\nExclusion Criteria:\n\n* Deformation of the hands or patients who have undergone joint arthrodesis or arthroplasty\n* 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\n* Lymphoedema in arms or hands following an axillary lymph node dissection\n* Immunosuppressive therapy for other autoimmune conditions \\\u003C2 years ago\n* Immunosuppressive therapy for other autoimmune conditions with B-cell depletion \\\u003C5 years ago\n* Haematological or oncological treatments involving induction and \u002F or maintenance chemotherapy \\\u003C5 years\n* Aged \\>80 years\n* 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\n* Inability to provide written informed consent\n* Severe cognitive impairment, severe psychiatric conditions or other inability to follow the procedures of the study\n* No regular access (weekly) to a smartphone\n* Adults who lack capacity to consent, known pregnant and breastfeeding women\n* 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)\n* Enrolment of the PI, his\u002Fher family members, employees and other dependent persons\n* 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","ALL","18 Years","80 Years",{"count":197,"type":198},320,"ESTIMATED","INTERVENTIONAL",[201],"NA","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.\n\nThe main questions it aims to answer are:\n\nIn 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?\n\nResearchers 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.\n\nParticipants will:\n\nBe assigned to a Low Disease Activity (LDA) or High Disease Activity (HDA) substudy based on their DAS28-CRP score at baseline.\n\nBe randomly assigned within their substudy to either the DETECTRA remote monitoring group or the standard-of-care group.\n\nIn the DETECTRA group, regularly provide patient-reported outcomes and perform self-imaging of their hands remotely using the DETECTRA application.\n\nAttend standard clinical assessments and be followed for 12 months.",[204,205],"Rheumatic Disorder","Rheumatoid Arthritis (RA)",[207,208,209],"rheumatoid arthritis","remote monitoring","flare detection","NOT_YET_RECRUITING","2026-09-29",{"date":213,"type":214},"2026-10-05","ACTUAL",{"date":216,"type":198},"2026-11-30",{"date":218,"type":198},"2028-12-30",{"name":5,"class":6},3]