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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02737-32 | Other Identifier | ANSM |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid arthritis (RA) with connected device | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connected device | Device | Connected device is a smart watch (with accelerometer without location data). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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RA patient with DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD
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| Name | Affiliation | Role |
|---|---|---|
| Hubert MAROTTE, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Besancon | Besançon | 25000 | France | |||
| Hôpital Pellegrin |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Bordeaux |
| France |
| Clinique de l'Infirmerie Protestante deLyon | Caluire-et-Cuire | France |
| Centre Hospitalier Universitaire de Clermont Ferrand | Clermont-Ferrand | 63000 | France |
| Hôpital Sud | Grenoble | France |
| CH Le Mans | Le Mans | France |
| CHU Montpellier | Montpellier | 34000 | France |
| Centre Hospitalier D'Orleans | Orléans | 45100 | France |
| Hôpital Pitié Salpétrière | Paris | France |
| CHU de Reims - Hôpital Maison Blanche | Reims | France |
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
| Hôpital Hautepierre | Strasbourg | France |
| Hôpital Pierre-Paul Riquet | Toulouse | France |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |