Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

NCT04749160 | Completed

• 2 other identifiers: 20CH1912020-A02737-32
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 13

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis (RA); synthetic disease modifying antirheumatic drug (csDMARD); biologic disease modifying antirheumatic drug (bDMARD); Machine Learning

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Connected device DEVICE

Connected device is a smart watch (with accelerometer without location data).

Rheumatoid arthritis (RA) with connected device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (13)

Centre Hospitalier de Besancon

Besançon, 25000, France

Location

Hôpital Pellegrin

Bordeaux, France

Location

Clinique de l'Infirmerie Protestante deLyon

Caluire-et-Cuire, France

Location

Centre Hospitalier Universitaire de Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

Hôpital Sud

Grenoble, France

Location

CH Le Mans

Le Mans, France

Location

CHU Montpellier

Montpellier, 34000, France

Location

Centre Hospitalier D'Orleans

Orléans, 45100, France

Location

Hôpital Pitié Salpétrière

Paris, France

Location

CHU de Reims - Hôpital Maison Blanche

Reims, France

Location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Hôpital Hautepierre

Strasbourg, France

Location

Hôpital Pierre-Paul Riquet

Toulouse, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hubert MAROTTE, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 11, 2021
• Study Start: June 4, 2021
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)