Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

Study Overview
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Brief Summary
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European recommendations indicate to start a conventional synthetic disease modifying antirheumatic drug (csDMARD) as soon as possible to reach the remission in early RA or low disease activity in established RA. If the target is not achieved with the first csDMARD and in presence of poor prognostic, addition of a biologic (b)DMARD or a targeted synthetic (ts)DMARD should be considered . Nevertheless, as many as one-third of patients have persistent disease activity and insufficient (inadequate) response to a first b/tsDMARD according to international recommendations. This relatively long time (3 to 6 months) between treatment initiation and determination of individual clinical response represents: a risk for the patient who could be usually exposed to potential side effects, a loss of chance for the patient who will not receive an adequate treatment during the most favorable period and thus may develop irreversible lesions a cost for the healthcare system, especially in terms of expensive drug reimbursements, notwithstanding the increasing use of biosimilars. Despite 20 years of research, no biomarker or no way are available in the daily practice to predict disease activity and the non-response to a b/tDMARD [11]. Thus exploration of a new approach is totally in purpose. The aim of this project is to benefit from the declarative PRO (Patient Reported Outcomes), the physical activity and sleep quality to predict the individual clinical response to the b/tsDMARDs

Official Title
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Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Device: Connected device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Social security affiliation Signed informed consent Adult patient (over 18 years old) RA according to ACR/EULAR 2010 criteria since less than 6 months DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD Having an internet access at home and using an email address Exclusion Criteria: Other arthritis than RA To participate to a blind-randomized study to assess RA treatment Pregnancy or breastfeeding Patient unable to understand the study, unable to give consent Patient deprived of liberty or patient under guardianship Patient refusing to participate in the study Patients having difficulty using connected objects

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rheumatoid arthritis (RA) with connected device<br>RA with DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD. the physical activity and sleep quality measured with connected device | Device: Connected device<br>* Connected device is a smart watch (with accelerometer without location data).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activities | Physical activities including number of steps per day and per hour. Physical activities are measured with a smart watch (with accelerometer without location data) | 3 months | 
| physical activities and sleep quality | sleep quality data including time of sleeping (number of hours). sleep quality is measured with a smart watch (with accelerometer without location data) | 3 months | 
| Rapid-3 score | Routine Assessment of Patient Index Data (Rapid-3) score is a self-administered score demonstrated capacity to capture Rheumatoid arthritis activity (score : 0,0 to 30,0). Remission : score 0- 3,0 Low Disease Activity : score 3,1- 6,0 Moderate Disease Activity : score 6,1 - 12,0 High Disease Activity : score 12,1 - 30 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Machine Learning, Rheumatoid arthritis (RA), synthetic disease modifying antirheumatic drug (csDMARD), biologic disease modifying antirheumatic drug (bDMARD)