A Study to Validate Questionnaires FLARE and OM-RA-FLARE Measuring Disease Flares in Patients With Rheumatoid Arthritis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 207
- Locations
- 26
- Primary Endpoint
- The validity of the questionnaire FLARE.
Study Overview
Brief Summary
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
Detailed Description
There will be 6 months of follow up including 3 medical visits for each patients:
- M0 (medical visit for inclusion)
- follow up between M0 - M3
- M3 (medical visit at 3 months after inclusion)
- follow up between M3 - M6
- M6 (medical visit at 6 months after inclusion)
At the inclusion visit (M0), after the verification of inclusion and non-inclusion criteria, the following information will be collected:
- Socio-demographical data : age, sex, level of education (primary, secondary, college, university), occupational category (INSEE in 6 categories)
- Items of the ACR 1987 and ACR/EULAR 2010;
- Length of the RA
- Erosive or not (presence Yes / no)
- IgM rheumatoid factor (presence Yes / No)
- Anti CCP antbodies (presence Yes / No)
During follow-up visits (M3 and M6), the elements collected are:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
The validity of the questionnaire 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).
Secondary Outcomes
- The discriminating power of the instrument FLARE.(6 mois.)
- The feasibility of the questionnaire FLARE(6 months.)