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

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

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13385
    • Service de Rhumatologie, CHU Conception
  • Montpellier, France, 34295
    • Fédération de Rhumatologie, CHU Lapeyronie
  • Paris, France, 75018
    • Service de Rhumatologie, APHP - CHU Bichat
  • Paris, France, 75651
    • Service de Rhumatologie, APHP - GH Pitié Salpêtrière
  • Poitiers, France, 86021
    • Service de rhumatologie, CHU de Poitiers
  • Toulouse, France, 31059
    • Service de Rhumatologie, Hôpital Larey
  • Bourgogne
    • Dijon, Bourgogne, France, 21033
      • Service de Rhumatologie, CHU Hôpital Général
  • Bretagne
    • Brest, Bretagne, France, 29607
      • Service de Rhumatologie, CHU La Cavale Blanche
    • Nantes, Bretagne, France, 44093
      • Service de Rhumatologie, CHRU Hôtel Dieu
  • Franche-Comté
    • Besançon, Franche-Comté, France, 25030
      • Service de Rhumatologie, CHU Jean Minjoz
  • La Martinique
    • Fort de France, La Martinique, France, 97261
      • Service de Rhumatologie, CHU Fort de France
  • Normandie
    • Rouen, Normandie, France, 76233
      • Service de Rhumatologie, Hôpitaux de Rouen
  • Rhône-Alpes
    • Grenoble, Rhône-Alpes, France, 38130
      • Service de Rhumatologie, CHU - Hôpital Sud A. Michallon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: DAS 28; Patients in this group will be asked to fill basic questionnaires, but without the FLARE questionnaires.
Active Comparator: DAS 28 + FLARE questionnaires; Patients in this group will be asked to fill basic questionnaires and FLARE questionnaires.	Other: Questionnaire; Patients in groups 2 and 3 will be asked to fill in questionnaires FLARE.
Active Comparator: DAS 28+FLARE + information to doctor; Patients in this group will fill basic and FLARE questionnaires which then will be transmitted to physician.	Other: Questionnaire; Patients in groups 2 and 3 will be asked to fill in questionnaires FLARE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: University Hospital, Rouen; Centre Hospitalier Universitaire Dijon; University Hospital, Montpellier; Poitiers University Hospital; Centre Hospitalier Universitaire de Besancon; University Hospital, Grenoble; University Hospital, Toulouse; Nantes University Hospital; Groupe Hospitalier Pitie-Salpetriere; University Hospital Center of Martinique; Bichat Hospital; Centre Hospitalier Régional et Universitaire de Brest
• Investigators: Principal Investigator: Francis Guillemin, MD, PhD, CIC-EC Inserm, CHU de Nancy; Principal Investigator: Bruno Fautrel, MD, PhD, Service de Rhumatologie, Groupe Hospitalier Pitié - Salpêtrière, Paris; Principal Investigator: Jacques Morel, MD, PhD, Service d'immunorhumatologie, Hôpital Lapeyronie, Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 26, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 2011-A01349-32