A Study to Validate Questionnaires FLARE and OM-RA-FLARE Measuring Disease Flares in Patients With Rheumatoid Arthritis.

A Study to Validate Questionnaires FLARE and OM-RA-FLARE Measuring Disease Flares in Patients With Rheumatoid Arthritis.

Sponsors

Lead sponsor: Central Hospital, Nancy, France

Collaborator: Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Régional et Universitaire de Brest
Centre Hospitalier Universitaire Dijon
University Hospital, Grenoble
University Hospital Center of Martinique
University Hospital, Montpellier
Nantes University Hospital
Bichat Hospital
Groupe Hospitalier Pitie-Salpetriere
Poitiers University Hospital
University Hospital, Rouen
University Hospital, Toulouse

Source Central Hospital, Nancy, France
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.

Overall Status Completed
Start Date March 2012
Completion Date June 2014
Primary Completion Date June 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The validity of the questionnaire FLARE. 6 mois
Secondary Outcome
Measure Time Frame
The discriminating power of the instrument FLARE. 6 mois.
The feasibility of the questionnaire FLARE 6 months.
Enrollment 207
Condition
Intervention

Intervention type: Other

Intervention name: Questionnaire

Description: Patients in groups 2 and 3 will be asked to fill in questionnaires FLARE.

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility
Service de Rhumatologie, CHU Hôpital Général | Dijon, Bourgogne, 21033, France
Service de Rhumatologie, CHU La Cavale Blanche | Brest, Bretagne, 29607, France
Service de Rhumatologie, CHRU Hôtel Dieu | Nantes, Bretagne, 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, Normandie, 76233, France
Service de Rhumatologie, CHU - Hôpital Sud A. Michallon | Grenoble, Rhône-Alpes, 38130, France
Service de Rhumatologie, CHU Conception | Marseille, 13385, France
Fédération de Rhumatologie, CHU Lapeyronie | Montpellier, 34295, France
Service de Rhumatologie, APHP - CHU Bichat | Paris, 75018, France
Service de Rhumatologie, APHP - GH Pitié Salpêtrière | Paris, 75651, France
Service de Rhumatologie, CHU de Poitiers | Poitiers, 86021, France
Service de Rhumatologie, Hôpital Larey | Toulouse, 31059, France
Location Countries

France

Verification Date

January 2012

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: DAS 28

Arm group type: No Intervention

Description: Patients in this group will be asked to fill basic questionnaires, but without the FLARE questionnaires.

Arm group label: DAS 28 + FLARE questionnaires

Arm group type: Active Comparator

Description: Patients in this group will be asked to fill basic questionnaires and FLARE questionnaires.

Arm group label: DAS 28+FLARE + information to doctor

Arm group type: Active Comparator

Description: Patients in this group will fill basic and FLARE questionnaires which then will be transmitted to physician.

Acronym FLARE
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov