Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T (SMART²T)

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Device: Connected device

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Centre Hospitalier de Besançon
  • Bordeaux, France
    • Hôpital Pellegrin
  • Caluire-et-Cuire, France
    • Clinique de l'Infirmerie Protestante deLyon
  • Clermont-Ferrand, France, 63000
    • Centre Hospitalier Universitaire de Clermont Ferrand
  • Grenoble, France
    • Hopital Sud
  • Le Mans, France
    • CH Le mans
  • Montpellier, France, 34000
    • CHU Montpellier
  • Orléans, France, 45100
    • Centre Hospitalier d'Orléans
  • Paris, France
    • Hopital Pitie Salpetriere
  • Reims, France
    • CHU de Reims - Hôpital Maison Blanche
  • Saint-Étienne, France, 42055
    • CHU Saint-Etienne
  • Strasbourg, France
    • Hôpital Hautepierre
  • Toulouse, France
    • Hôpital Pierre-Paul Riquet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

RA patient with DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rheumatoid arthritis (RA) with 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	Device: Connected device; Connected device is a smart watch (with accelerometer without location data).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Hubert MAROTTE, PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Actual): February 20, 2022
• Study Completion (Actual): February 20, 2022

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Machine Learning; Rheumatoid arthritis (RA); synthetic disease modifying antirheumatic drug (csDMARD); biologic disease modifying antirheumatic drug (bDMARD)
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 20CH191; 2020-A02737-32 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No