DETECTRA: Remote Monitoring to Detect Rheumatoid Arthritis Flares and Treatment Response

NCT ID
NCT07857993
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Centre Hospitalier Universitaire Vaudois
Conditions
Rheumatic Disorder, Rheumatoid Arthritis (RA)

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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.

Enrollment: 320 participants (Estimated).

What is being studied

  • Device: DETECTRA
  • Intervention: Health Care Quality, Access, and Evaluation
  • Intervention: Health Services Administration
  • Intervention: Quality Indicators, Health Care
  • Intervention: Quality of Health Care
  • Intervention: Standard of Care
  • Other: Standard of Care (SOC)

Who may be eligible

Ages
18 Years to 80 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

3 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Austria, Germany

Sample of listed locations

  • Medical University Vienna — Vienna, Austria — Site recruitment status not specified in the registry data
  • Charite Universitätsmedizin Berlin — Berlin, Germany — Site recruitment status not specified in the registry data
  • Ruhr University Bochum — Bochum, Germany — Site recruitment status not specified in the registry data

Study details

Start date
November 30, 2026
Primary completion date
December 30, 2028
Completion date
December 30, 2028
First posted
October 5, 2026
Collaborators
Horizon 2020 - European Commission, Staatssekretariat für Bildung Forschung und Innovation SBFI

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07857993
Registry last updated
October 5, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07857993 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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