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

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

Conditions

• Arthritis, Rheumatoid

Interventions

OTHER

Questionnaire

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• Centre Hospitalier Régional et Universitaire de Brest

  collaborator OTHER

• Centre Hospitalier Universitaire Dijon

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• University Hospital Center of Martinique

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Bichat Hospital

  collaborator OTHER

• Groupe Hospitalier Pitie-Salpetriere

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• Central Hospital, Nancy, France

  lead OTHER

Principal Investigators

• Francis Guillemin, MD, PhD · CIC-EC Inserm, CHU de Nancy

• Bruno Fautrel, MD, PhD · Service de Rhumatologie, Groupe Hospitalier Pitié - Salpêtrière, Paris

• Jacques Morel, MD, PhD · Service d'immunorhumatologie, Hôpital Lapeyronie, Montpellier

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2014-06-30

Completion

2014-06-30

Countries

• France

Study Locations