Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

Rheumatoid Arthritis Clinical Trial

— SMART²T  

Official title:

Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749160
• Other study ID #: 20CH191
• Secondary ID: 2020-A02737-32
• Status: Completed
• Start date: June 4, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 20, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier de Besancon	Besançon
France	Hôpital Pellegrin	Bordeaux
France	Clinique de l'Infirmerie Protestante deLyon	Caluire-et-Cuire
France	Centre Hospitalier Universitaire de Clermont Ferrand	Clermont-Ferrand
France	Hôpital Sud	Grenoble
France	CH Le Mans	Le Mans
France	CHU Montpellier	Montpellier
France	Centre Hospitalier D'Orleans	Orléans
France	Hôpital Pitié Salpétrière	Paris
France	CHU de Reims - Hôpital Maison Blanche	Reims
France	CHU Saint-Etienne	Saint-Étienne
France	Hôpital Hautepierre	Strasbourg
France	Hôpital Pierre-Paul Riquet	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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