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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04749160
Other study ID # 20CH191
Secondary ID 2020-A02737-32
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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