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Not Yet Recruiting NCT07857993

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

Conditions: Rheumatic Disorder, Rheumatoid Arthritis (RA)

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 320
Sponsor: Centre Hospitalier Universitaire Vaudois

Location: Medical University Vienna Vienna

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. 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.

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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07857993). StuddyBuddy aggregates publicly available trial information.