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

ConditionsRheumatic Disorder Rheumatoid Arthritis (RA)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorCentre Hospitalier Universitaire Vaudois

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

DETECTRA
Device
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 (SOC)
Other intervention
Standard of care for rheumatoid arthritis informed by EULAR guidelines.

Treatment groups

320 Participants

are divided into 4 treatment groups

Group A: DETECTRA low disease activity (LDA)Experimental treatment 1 intervention

Group B: DETECTRA high disease activity (HDA)Experimental treatment 1 intervention

Group C: Standard of Care - low disease activityOther 1 intervention

Group D: Standard of Care - high disease activityOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Time frame

From enrollment to the end of study at 12months.

Secondary outcomes

Diagnostic accuracy

Diagnostic accuracy of the DETECTRA system to differentiate between presence and absence of a flare / non-response / 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).

Time frame

From study enrollment until end of study at 12months.

Sensitivity

Missed flares/non-response / 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.

Time frame

From study enrollment until end of study at 12months.

Specificity

False flares/detection of non-response / 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 / insufficient response to treatment.

Time frame

From enrollment until end of study at 12months.

Adherence

Percentage of submissions on the application (totally expected submissions = every week until end of trial) for patients in the DETECTRA intervention group.

Time frame