Clinical trial NCT01722617: A Study to Validate Questionnaires FLARE and OM-RA-FLARE Measuring Disease Flares in Patients With Rheumatoid Arthritis.
Official title: A Study to Validate Questionnaires FLARE and OM-RA-FLARE Measuring Disease Flares in Patients With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Besancon
name: Centre Hospitalier Régional et Universitaire de Brest
name: Centre Hospitalier Universitaire Dijon
name: University Hospital, Grenoble
name: University Hospital Center of Martinique
name: University Hospital, Montpellier
name: Nantes University Hospital
name: Bichat Hospital
name: Groupe Hospitalier Pitie-Salpetriere
name: Poitiers University Hospital
name: University Hospital, Rouen
name: University Hospital, Toulouse
First posted: 2012-11-07
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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:

1. by the study technician (TEC)

   * the inflammatory activity index, evaluated by patient (RAPID-3);
   * the functional limitations index (HAQ);
   * the PASS questionnaire;
   * the OM-RA-FLARE questionnaire;
   * the FLARE questionnaire.
2. 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 :

     * DMRADs: continuing the treatment, decreasing or increasing the dose, changing it due to its ineffectiveness, changing it due to patients' intolerance.
     * Symptomatic treatments: continuing corticosteroids, increase the dose of corticosteroids, corticosteroid infiltration.

Eligibility criteria: 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.

Primary outcomes:
measure: The validity of the questionnaire FLARE.
timeFrame: 6 mois
Secondary outcomes:
measure: The discriminating power of the instrument FLARE.
timeFrame: 6 mois.
measure: The feasibility of the questionnaire FLARE
timeFrame: 6 months.
Other outcomes:
Locations:
city: Dijon
country: France
facility: Service de Rhumatologie, CHU Hôpital Général
state: Bourgogne
city: Brest
country: France
facility: Service de Rhumatologie, CHU La Cavale Blanche
state: Bretagne
city: Nantes
country: France
facility: Service de Rhumatologie, CHRU Hôtel Dieu
state: Bretagne
city: Besançon
country: France
facility: Service de Rhumatologie, CHU Jean Minjoz
state: Franche-Comté
city: Fort de France
country: France
facility: Service de Rhumatologie, CHU Fort de France
state: La Martinique
city: Rouen
country: France
facility: Service de Rhumatologie, Hôpitaux de Rouen
state: Normandie
city: Grenoble
country: France
facility: Service de Rhumatologie, CHU - Hôpital Sud A. Michallon
state: Rhône-Alpes
city: Marseille
country: France
facility: Service de Rhumatologie, CHU Conception
city: Montpellier
country: France
facility: Fédération de Rhumatologie, CHU Lapeyronie
city: Paris
country: France
facility: Service de Rhumatologie, APHP - CHU Bichat
city: Paris
country: France
facility: Service de Rhumatologie, APHP - GH Pitié Salpêtrière
city: Poitiers
country: France
facility: Service de Rhumatologie, CHU de Poitiers
city: Toulouse
country: France
facility: Service de Rhumatologie, Hôpital Larey
Study officials:
affiliation: CIC-EC Inserm, CHU de Nancy
name: Francis Guillemin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Rhumatologie, Groupe Hospitalier Pitié - Salpêtrière, Paris
name: Bruno Fautrel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service d'immunorhumatologie, Hôpital Lapeyronie, Montpellier
name: Jacques Morel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.