Skip to main content
OpenTrials
Completed

NCT Number: NCT01722617

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Rhumatologie, CHU - Hôpital Sud A. Michallon, Grenoble, Auvergne-Rhône-Alpes, France

Loading trial locations.

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. The validity of the questionnaire FLARE.

    Time frame: 6 mois

    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 outcomes

  1. The discriminating power of the instrument FLARE.

    Time frame: 6 mois.

    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.

  2. The feasibility of the questionnaire FLARE

    Time frame: 6 months.

    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.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

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

Registry information

Acronym: FLARE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2012
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.