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

Arthritis, Rheumatoid Clinical Trial

— FLARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722617
• Other study ID #: 2011-A01349-32
• Status: Completed
• Phase: N/A
• First received: October 26, 2012
• Last updated: September 22, 2015
• Start date: March 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2012
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Other:
• Questionnaire
Patients in groups 2 and 3 will be asked to fill in questionnaires FLARE.

Locations

Country	Name	City	State
France	Service de Rhumatologie, CHU Jean Minjoz	Besançon	Franche-Comté
France	Service de Rhumatologie, CHU La Cavale Blanche	Brest	Bretagne
France	Service de Rhumatologie, CHU Hôpital Général	Dijon	Bourgogne
France	Service de Rhumatologie, CHU Fort de France	Fort de France	La Martinique
France	Service de Rhumatologie, CHU - Hôpital Sud A. Michallon	Grenoble	Rhône-Alpes
France	Service de Rhumatologie, CHU Conception	Marseille
France	Fédération de Rhumatologie, CHU Lapeyronie	Montpellier
France	Service de Rhumatologie, CHRU Hôtel Dieu	Nantes	Bretagne
France	Service de Rhumatologie, APHP - CHU Bichat	Paris
France	Service de Rhumatologie, APHP - GH Pitié Salpêtrière	Paris
France	Service de Rhumatologie, CHU de Poitiers	Poitiers
France	Service de Rhumatologie, Hôpitaux de Rouen	Rouen	Normandie
France	Service de Rhumatologie, Hôpital Larey	Toulouse

Sponsors (13)

Lead Sponsor

Collaborator

Central Hospital, Nancy, France

Bichat Hospital, Centre Hospitalier Régional et Universitaire de Brest, Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire de Fort-de-France, Centre Hospitalier Universitaire Dijon, Groupe Hospitalier Pitie-Salpetriere, Nantes University Hospital, Poitiers University Hospital, University Hospital, Grenoble, University Hospital, Montpellier, University Hospital, Rouen, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	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.	No