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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Central Hospital, Nancy, France.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Régional et Universitaire de Brest
Centre Hospitalier Universitaire Dijon
University Hospital, Grenoble
Centre Hospitalier Universitaire de Fort-de-France
University Hospital, Montpellier
Nantes University Hospital
Bichat Hospital
Groupe Hospitalier Pitie-Salpetriere
Centre Hospitalier Universitaire de Poitiers
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: November 5, 2012
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.


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (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
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

Contacts
Contact: Francis Guillemin, MD, PhD. +33 3 83 85 21 65 francis.guillemin@chu-nancy.fr
Contact: Irawati Lemonnier, MPH, PhD. +33 3 83 85 93 00 i.lemonnier@chu-nancy.fr

Locations
France
Service de Rhumatologie, CHU Hôpital Général Recruiting
Dijon, Bourgogne, France, 21033
Contact: Jean-Francis MAILLEFERT, MD    +33 3 80 29 37 45    jean-francis.maillefer@hu-dijon.fr   
Contact: Corinne CHEVALIER    +33 0 80 29 30 31 ext 16815    corinne.chevalier@chu-dijon.fr   
Principal Investigator: Jean-Francis MAILLEFERT, MD         
Sub-Investigator: Christine PIROTH, MD         
Service de Rhumatologie, CHU La Cavale Blanche Recruiting
Brest, Bretagne, France, 29607
Contact: Alain SARAUX, MD    +33 2 98 34 72 67    alain.saraux@univ-brest.fr   
Contact: Nathalie BIHANNIC    + 33 2 98 14 50 02    nathalie.bihannic@chu-brest.fr   
Principal Investigator: Alain SARAUX, MD         
Sub-Investigator: Divi CORNEC, MD         
Sub-Investigator: Valérie-Marie DEVAUCHELLE, MD         
Sub-Investigator: Sandrine JOUSSE-JOULIN, MD         
Sub-Investigator: Thierry MARHADOUR, MD         
Service de Rhumatologie, CHRU Hôtel Dieu Recruiting
Nantes, Bretagne, France, 44093
Contact: Jean-Marie BERTHELOT, MD    +33 2 40 08 48 22    jeanmarie.berthelot@chu-nantes.fr   
Contact: Sophie GIBELLI    +33 2 40 08 48 32    karen.batard@chu-nantes.fr   
Principal Investigator: Jean-Marie BERTHELOT, MD         
Service de Rhumatologie, CHU Jean Minjoz Recruiting
Besançon, Franche-Comté, France, 25030
Contact: Daniel WENDLING, MD    +33 3 81 66 82 41    dwendling@chu-besancon.fr   
Contact: Lucy ROCCHITELLI    +33 03 81 21 93 28    lrocchitelli@chu-besancon.fr   
Principal Investigator: Daniel WENDLING, MD         
Service de Rhumatologie, CHU Fort de France Recruiting
Fort de France, La Martinique, France, 97261
Contact: Georges JEAN-BAPTISE, MD, PhD       gcd.jeanbaptiste@orange.fr   
Contact: Michel DE BANDT, MD, PhD    +33 05 96 55 23 51    micheldebandt@gmail.com   
Principal Investigator: Michel DE BANDT, MD, PhD         
Service de Rhumatologie, Hôpitaux de Rouen Recruiting
Rouen, Normandie, France, 76233
Contact: Olivier VITTECOQ, MD    +33 02 32 88 90 19    Olivier.Vittecoq@chu-rouen.fr   
Contact: Aissa MEGEUHOUT    +33 2 32 88 93 24    aissa.megeuhout@chu-rouen.fr   
Principal Investigator: Olivier VITTECOQ, MD         
Sub-Investigator: Thierry LEQUERRE, MD         
Service de Rhumatologie, CHU - Hôpital Sud A. Michallon Recruiting
Grenoble, Rhône-Alpes, France, 38130
Contact: Philippe GAUDIN, MD    + 33 4 76 76 51 36    pgaudin@chu-grenoble.fr   
Contact: Réjane GRUEL    +33 4 76 76 72 23    rgruel@chu-grenoble.fr   
Principal Investigator: Philippe GAUDIN, MD         
Sub-Investigator: Mélanie GILSON, MD         
Service de Rhumatologie, CHU Conception Recruiting
Marseille, France, 13385
Contact: Thao PHAM, MD, PhD    +33 04 91 38 34 34    thao-pham@ap-hm.fr   
Principal Investigator: Thao PHAM, MD, PhD         
Sub-Investigator: Marie-Alix LANFRANCHI DEBRA, MD         
Fédération de Rhumatologie, CHU Lapeyronie Recruiting
Montpellier, France, 34295
Contact: Jacques MOREL, MD, PhD    +33 4 67 33 87 10    j-morel@chu-montpellier.fr   
Contact: Aurore GUILLARDEAU    +33 4 67 33 77 91    a-guillardeau@chu-montpellier.fr   
Principal Investigator: Jacques MOREL, MD, PhD         
Service de Rhumatologie, APHP - CHU Bichat Recruiting
Paris, France, 75018
Contact: Olivier MEYER, MD, PhD    +33 1 40 25 75 00    olivier.meyer@bch.aphp.fr   
Contact: Hagit ZYLBERMAN-YONA    +33 1 40 25 70 27    hagit.zylberman-yona@bch.aphp.fr   
Principal Investigator: Olivier MEYER, MD, PhD         
Sub-Investigator: Magali BALLARD, MD         
Sub-Investigator: Gilles HAYEM, MD         
Sub-Investigator: Sébastien OTTAVIANI, MD         
Sub-Investigator: Fabienne ROUX, MD         
Service de Rhumatologie, APHP - GH Pitié Salpêtrière Recruiting
Paris, France, 75651
Contact: Bruno FAUTREL, MD, PhD    +33 01 42 17 76 20    bruno.fautrel@psl.aphp.fr   
Contact: Nicolas VAILLANT    +33 1 42 17 71 97    nicolas.vaillant@psl.aphp.fr   
Principal Investigator: Bruno FAUTREL         
Sub-Investigator: Béatrice BANNEVILLE, MD         
Service de Rhumatologie, CHU de Poitiers Recruiting
Poitiers, France, 86021
Contact: Elizabeth SOLAU - GERVAIS, MD, PhD    +33 05 49 44 44 65    e.solau@chu-poitiers.fr   
Contact: Katia GOUROU    +33 5 49 44 32 83    katia.gourou@chu-poitiers.fr   
Principal Investigator: Elizabeth SOLAU - GERVAIS, MD, PhD         
Sub-Investigator: Rachel BRAULT, MD         
Sub-Investigator: Françoise DEBIAIS, MD         
Service de Rhumatologie, Hôpital Larey Recruiting
Toulouse, France, 31059
Contact: Arnaud CONSTANTIN, MD    +33 5 67 77 17 57    constant@cict.fr   
Contact: Marie-Hélène CERATO    +33 5 61 77 73 97    cerato.mh@chu-toulouse.fr   
Principal Investigator: Arnaud CONSTANTIN         
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
Centre Hospitalier Universitaire de Fort-de-France
University Hospital, Montpellier
Nantes University Hospital
Bichat Hospital
Groupe Hospitalier Pitie-Salpetriere
Centre Hospitalier Universitaire de Poitiers
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

No publications provided

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: November 5, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on November 20, 2014