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

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01722617
First received: October 26, 2012
Last updated: September 22, 2015
Last verified: January 2012
  Purpose

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


Condition Intervention
Arthritis, Rheumatoid
Other: Questionnaire

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Study to Validate Questionnaires FLARE and OM-RA-FLARE Measuring Disease Flares in Patients With Rheumatoid Arthritis.

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • The validity of the questionnaire FLARE. [ Time Frame: 6 mois ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The discriminating power of the instrument FLARE. [ Time Frame: 6 mois. ] [ Designated as safety issue: No ]
    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.

  • The feasibility of the questionnaire FLARE [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
    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.


Enrollment: 207
Study Start Date: March 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01722617

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

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01722617     History of Changes
Other Study ID Numbers: 2011-A01349-32 
Study First Received: October 26, 2012
Last Updated: September 22, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 21, 2016