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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Besancon | OTHER |
| Centre Hospitalier Régional et Universitaire de Brest | OTHER |
| Centre Hospitalier Universitaire Dijon | OTHER |
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Rheumatoid arthritis (RA) is a rheumatic inflammatory synovitis characterized by pain and joint swelling as well as thickening synovial (pannus) lesions that are responsible of osteocartilaginous and tendon damage. It evolves in spurts or long and variable intensity interspersed with remissions.
The effectiveness of treatment is based on the proportion of patients who achieve a certain degree of improvement over the initial level of various parameters such as response criteria ACR 20, 50 or 70% or EULAR based on the evolution of DAS 28 or DAS 44. These response criteria are now well validated but do not fully take into account the improvement of the patient's condition. In contrast, there is no questionnaire to identify the proportion of patients whose RA worsened between the medical visits. Such a questionnaire is necessary to detect flares outbreaks in daily practice and in randomized clinical trials, follow-up studies or longitudinal studies after drugs marketing to detect a reversal of disease activity.
Both STPR group and OMERACT group have each developed such a new self-administered questionnaire (FLARE and OM-RA-FLARE) to detect the flare- in RA patients.
The objective of this study is to validate the questionnaires FLARE and OM-RA-FLARE among RA patients using the methodology advocated by the OMERACT in terms of validity (truth), discriminating power (discrimination) and feasibility
There will be 6 months of follow up including 3 medical visits for each patients:
At the inclusion visit (M0), after the verification of inclusion and non-inclusion criteria, the following information will be collected:
During follow-up visits (M3 and M6), the elements collected are:
by the study technician (TEC)
by the doctor :
elements of DAS 28, this includes a blood test that will be done in the city or in the hospital ;
the doctor's decision at the end of the consultation, in terms of :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAS 28 | No Intervention | Patients in this group will be asked to fill basic questionnaires, but without the FLARE questionnaires. | |
| DAS 28 + FLARE questionnaires | Active Comparator | Patients in this group will be asked to fill basic questionnaires and FLARE questionnaires. |
|
| DAS 28+FLARE + information to doctor | Active Comparator | Patients in this group will fill basic and FLARE questionnaires which then will be transmitted to physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Patients in groups 2 and 3 will be asked to fill in questionnaires FLARE. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The validity of the questionnaire FLARE. | The validity of the questionnaire shows the characteristics of the questionnaires (its ability to comprise the aspects for which it was designed). It will be studied by calculating the correlation coefficients between FLARE / OM-RA-FLARE on one hand, and various measures of disease activities (DAS 28, RAPID-3, RAID and AUC). | 6 mois |
| Measure | Description | Time Frame |
|---|---|---|
| The discriminating power of the instrument FLARE. | The discriminating power, i.e.the degree of precision for each particular instrument, considered individually, will be assessed by its reproducibility, sensitivity to change and its impact on medical decision making. | 6 mois. |
| The feasibility of the questionnaire FLARE |
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Inclusion Criteria:
Age ≥ 18 years;
Having Rheumatoid Arthritis (RA) since more than 6 months, meeting the ACR 1987 and the ACR / EULAR 2010;
Treatment of RA:
Receive the medical exam first;
Agreed and signed the informed consent form;
Ability to comply with the study protocol;
Having the social insurance coverage
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis Guillemin, MD, PhD | CIC-EC Inserm, CHU de Nancy | Principal Investigator |
| Bruno Fautrel, MD, PhD | Service de Rhumatologie, Groupe Hospitalier Pitié - Salpêtrière, Paris | Principal Investigator |
| Jacques Morel, MD, PhD | Service d'immunorhumatologie, Hôpital Lapeyronie, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Rhumatologie, CHU - Hôpital Sud A. Michallon | Grenoble | Auvergne-Rhône-Alpes | 38130 | France | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27636400 | Derived | Fautrel B, Morel J, Berthelot JM, Constantin A, De Bandt M, Gaudin P, Maillefert JF, Meyer O, Pham T, Saraux A, Solau-Gervais E, Vittecoq O, Wendling D, Erpelding ML, Guillemin F; STPR Group of the French Society of Rheumatology. Validation of FLARE-RA, a Self-Administered Tool to Detect Recent or Current Rheumatoid Arthritis Flare. Arthritis Rheumatol. 2017 Feb;69(2):309-319. doi: 10.1002/art.39850. |
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| University Hospital, Grenoble |
| OTHER |
| University Hospital Center of Martinique | OTHER |
| University Hospital, Montpellier | OTHER |
| Nantes University Hospital | OTHER |
| Bichat Hospital | OTHER |
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
| Poitiers University Hospital | OTHER |
| University Hospital, Rouen | OTHER |
| University Hospital, Toulouse | OTHER |
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The feasibility will be measured by the percentage of non-calculable scores (missing data) and the number of items that are not filled for calculable scores. |
| 6 months. |
| Service de Rhumatologie, CHU Hôpital Général |
| Dijon |
| Bourgogne-Franche-Comté |
| 21033 |
| France |
| Service de Rhumatologie, CHU La Cavale Blanche | Brest | Brittany Region | 29607 | France |
| Service de Rhumatologie, CHRU Hôtel Dieu | Nantes | Brittany Region | 44093 | France |
| Service de Rhumatologie, CHU Jean Minjoz | Besançon | Franche-Comté | 25030 | France |
| Service de Rhumatologie, CHU Fort de France | Fort de France | La Martinique | 97261 | France |
| Service de Rhumatologie, Hôpitaux de Rouen | Rouen | Normandy | 76233 | France |
| Service de Rhumatologie, APHP - CHU Bichat | Paris | Paris | 75018 | France |
| Service de Rhumatologie, APHP - GH Pitié Salpêtrière | Paris | Paris | 75651 | France |
| Service de Rhumatologie, CHU Conception | Marseille | 13385 | France |
| Fédération de Rhumatologie, CHU Lapeyronie | Montpellier | 34295 | France |
| Service de Rhumatologie, CHU de Poitiers | Poitiers | 86021 | France |
| Service de Rhumatologie, Hôpital Larey | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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