Arthritis, Rheumatoid Clinical Trial
— FLAREOfficial title:
A Study to Validate Questionnaires FLARE and OM-RA-FLARE Measuring Disease Flares in Patients With Rheumatoid Arthritis.
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
Status | Completed |
Enrollment | 207 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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: - Treatment of disease modifying anti-rheumatic drugs (DRMADs) or biological treatment stable for more than 2 months; - Symptomatic treatment (including corticosteroid) stable for more than 2 months; - 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: - Patients undergoing surgery during the study period; - Patients without any affiliation to a social security coverage (or entitled beneficiary); - Patients under guardianship or trusteeship. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | Service de Rhumatologie, CHU Jean Minjoz | Besançon | Franche-Comté |
France | Service de Rhumatologie, CHU La Cavale Blanche | Brest | Bretagne |
France | Service de Rhumatologie, CHU Hôpital Général | Dijon | Bourgogne |
France | Service de Rhumatologie, CHU Fort de France | Fort de France | La Martinique |
France | Service de Rhumatologie, CHU - Hôpital Sud A. Michallon | Grenoble | Rhône-Alpes |
France | Service de Rhumatologie, CHU Conception | Marseille | |
France | Fédération de Rhumatologie, CHU Lapeyronie | Montpellier | |
France | Service de Rhumatologie, CHRU Hôtel Dieu | Nantes | Bretagne |
France | Service de Rhumatologie, APHP - CHU Bichat | Paris | |
France | Service de Rhumatologie, APHP - GH Pitié Salpêtrière | Paris | |
France | Service de Rhumatologie, CHU de Poitiers | Poitiers | |
France | Service de Rhumatologie, Hôpitaux de Rouen | Rouen | Normandie |
France | Service de Rhumatologie, Hôpital Larey | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France | Bichat Hospital, Centre Hospitalier Régional et Universitaire de Brest, Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire de Fort-de-France, Centre Hospitalier Universitaire Dijon, Groupe Hospitalier Pitie-Salpetriere, Nantes University Hospital, Poitiers University Hospital, University Hospital, Grenoble, University Hospital, Montpellier, University Hospital, Rouen, University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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. | No |
Secondary | The feasibility of the questionnaire FLARE | 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. | No |
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