Questionnaire
OtherPatients in groups 2 and 3 will be asked to fill in questionnaires FLARE.
NCT Number: NCT01722617
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Service de Rhumatologie, CHU - Hôpital Sud A. Michallon, Grenoble, Auvergne-Rhône-Alpes, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in groups 2 and 3 will be asked to fill in questionnaires FLARE.
Time frame: 6 mois
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).
Time frame: 6 mois.
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.
Time frame: 6 months.
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.
Central Hospital, Nancy, France
Other
Acronym: FLARE
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.
NCT04196868
Arthritis, Arthritis, Rheumatoid
Bayonne, France
View Trial DetailsNCT02615951
Arthritis, Arthritis, Rheumatoid
Montpellier, Hérault, France
View Trial DetailsNCT05961267
Ankylosis, Arthritis
Bordeaux, France
View Trial DetailsNCT06276387
Arthritis, Arthritis, Rheumatoid
San Francisco, California, United States
View Trial Details