Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Device: Connected device

Study type: Observational

Funder types: Other

Identifiers

NCT04749160

2020-A02737-32 (Other Identifier)

20CH191

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

26 participants in 1 patient group

Rheumatoid arthritis (RA) with connected device

Description:

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

Treatment:

Device: Connected device