Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Besancon, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Connected device

Device

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

Primary outcomes

physical activities

Time frame: 3 months

Physical activities including number of steps per day and per hour. Physical activities are measured with a smart watch (with accelerometer without location data)
physical activities and sleep quality

Time frame: 3 months

sleep quality data including time of sleeping (number of hours). sleep quality is measured with a smart watch (with accelerometer without location data)
Rapid-3 score

Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: SMART²T

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Feb 11, 2021
Registry last updated: Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed