Clinical trial NCT04749160: Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T
Official title: Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis (RA)
synthetic disease modifying antirheumatic drug (csDMARD)
biologic disease modifying antirheumatic drug (bDMARD)
Machine Learning
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: physical activities
timeFrame: 3 months
measure: physical activities and sleep quality
timeFrame: 3 months
measure: Rapid-3 score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier de Besancon
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Caluire-et-Cuire
country: France
facility: Clinique de l'Infirmerie Protestante deLyon
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont Ferrand
city: Grenoble
country: France
facility: Hôpital Sud
city: Le Mans
country: France
facility: CH Le Mans
city: Montpellier
country: France
facility: CHU Montpellier
city: Orléans
country: France
facility: Centre Hospitalier D'Orleans
city: Paris
country: France
facility: Hôpital Pitié Salpétrière
city: Reims
country: France
facility: CHU de Reims - Hôpital Maison Blanche
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Strasbourg
country: France
facility: Hôpital Hautepierre
city: Toulouse
country: France
facility: Hôpital Pierre-Paul Riquet
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hubert MAROTTE, PhD
role: PRINCIPAL_INVESTIGATOR
References: