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

A vizsgálat adatai

Ki végzi

Centre Hospitalier Universitaire Vaudois

Azonosító

NCT07857993

A regiszteradat frissítve

2026. október 5.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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:

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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; Severe cognitive impairment, severe psychiatric conditions or other inability to follow the procedures of the study; 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; 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; 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; Deformation of the hands or patients who have undergone joint arthrodesis or arthroplasty; Lymphoedema in arms or hands following an axillary lymph node dissection; Inability to provide written informed consent; 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.

ClinicalTrials.gov NCT07857993