Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Device: Connected device

• Registration Number: NCT04749160
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-11
• Study Start: 2021-06-04
• Primary Completion: 2022-02-20
• Study Completion: 2022-02-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid arthritis (RA) with connected device	Connected device	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

Primary Outcome Measures

Name	Time	Method
physical activities and sleep quality	3 months	sleep quality data including time of sleeping (number of hours). sleep quality is measured with a smart watch (with accelerometer without location data)
Rapid-3 score	3 months	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
physical activities	3 months	Physical activities including number of steps per day and per hour. Physical activities are measured with a smart watch (with accelerometer without location data)

Trial Locations

Locations (13)

Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Centre Hospitalier Universitaire de Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France

Hôpital Sud; 🇫🇷 Grenoble, France

Centre Hospitalier de Besancon; 🇫🇷 Besançon, France

Clinique de l'Infirmerie Protestante deLyon; 🇫🇷 Caluire-et-Cuire, France

CHU de Reims - Hôpital Maison Blanche; 🇫🇷 Reims, France

Centre Hospitalier D'Orleans; 🇫🇷 Orléans, France

CHU Montpellier; 🇫🇷 Montpellier, France

CH Le Mans; 🇫🇷 Le Mans, France

Hôpital Pitié Salpétrière; 🇫🇷 Paris, France

Hôpital Hautepierre; 🇫🇷 Strasbourg, France

Hôpital Pierre-Paul Riquet; 🇫🇷 Toulouse, France