JMIR Publications

ABSTRACT

Background:

Rheumatoid arthritis (RA) disease activity during disease-modifying antirheumatic drug (DMARD) tapering is commonly monitored using in-person clinical assessment and the 28-joint Disease Activity Score with C-reactive protein (DAS28-CRP). Although effective, this approach is resource intensive and may be inconvenient for patients. Remote monitoring using patient-reported outcome measures and wearable sensors may offer a practical way to detect flare earlier and support safer tapering pathways. Prior pilot work suggests that accelerometery-derived physical activity, mobility, and sleep metrics are associated with RA disease activity and are acceptable to patients.

Objective:

This protocol aims to evaluate the feasibility and diagnostic accuracy of remote monitoring for detecting RA flare during DMARD tapering. The study will (1) continuously measure physical activity using wrist-worn accelerometers, (2) collect weekly Rheumatoid Arthritis Flare Questionnaire (RA-FQ) scores, (3) develop a joint modelling framework to estimate flare risk from longitudinal activity data, and (4) retrospectively assess prediction accuracy against patient- and clinician-defined flare onset.

Methods:

This is a prospective observational cohort study embedded within the ROADMAP DMARD tapering clinic at the Freeman Hospital, Newcastle upon Tyne, United Kingdom. Adults with clinician-confirmed RA in remission (DAS28-CRP <2.4) who are undergoing or about to start DMARD tapering and can walk independently will be recruited. The target sample size is 100 patients. Study visits are aligned with routine ROADMAP appointments and include baseline and week 12 assessments, with an optional 12-week extension (week 24) and ad hoc visits for suspected flare. Patients will wear wrist-worn Axivity AX6 devices continuously for 12 weeks (three devices worn sequentially for 28 days each), with an optional further 12 weeks in the extension phase. Weekly RA-FQ data will be collected via REDCap or paper questionnaires if needed. Clinical assessments include tender and swollen joint counts, patient and physician visual analogue scales, C-reactive protein, DAS28-CRP, and Health Assessment Questionnaire Disability Index scores. Flare status will be defined using clinician assessment supported by DAS28-CRP and/or swollen joint count criteria. A joint modelling framework combining longitudinal accelerometery-derived metrics and time-to-event analysis will generate daily flare-risk predictions. Model performance will be evaluated using area under the receiver operating characteristic curve, sensitivity, specificity, predictive values, and lead time to flare detection.

Results:

As of April 2026, 16 patients have been recruited. This protocol reports the study design, procedures, and planned analyses; outcome analyses will be reported after follow-up completion.

Conclusions:

This study will provide pilot evidence on the feasibility and accuracy of multimodal remote monitoring for RA flare detection during DMARD tapering in routine care. Findings will inform model refinement, external validation, and future larger multicentre studies evaluating clinical utility and service impact.