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

NCT ID: NCT01722617

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-06-30

Brief 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

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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

DAS 28

Patients in this group will be asked to fill basic questionnaires, but without the FLARE questionnaires.

Group Type: NO_INTERVENTION

No interventions assigned to this group

DAS 28 + FLARE questionnaires

Patients in this group will be asked to fill basic questionnaires and FLARE questionnaires.

Group Type: ACTIVE_COMPARATOR

Questionnaire

Intervention Type: OTHER

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

DAS 28+FLARE + information to doctor

Patients in this group will fill basic and FLARE questionnaires which then will be transmitted to physician.

Group Type: ACTIVE_COMPARATOR

Questionnaire

Intervention Type: OTHER

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

Interventions

Questionnaire

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: collaborator

Centre Hospitalier Régional et Universitaire de Brest

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: collaborator

Bichat Hospital

OTHER

Sponsor Role: collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role: collaborator

Poitiers University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis Guillemin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CIC-EC Inserm, CHU de Nancy

Bruno Fautrel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Rhumatologie, Groupe Hospitalier Pitié - Salpêtrière, Paris

Jacques Morel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service d'immunorhumatologie, Hôpital Lapeyronie, Montpellier

Locations

Service de Rhumatologie, CHU - Hôpital Sud A. Michallon

Grenoble, Auvergne-Rhône-Alpes, France

Service de Rhumatologie, CHU Hôpital Général

Dijon, Bourgogne-Franche-Comté, France

Service de Rhumatologie, CHU La Cavale Blanche

Brest, Brittany Region, France

Service de Rhumatologie, CHRU Hôtel Dieu

Nantes, Brittany Region, France

Service de Rhumatologie, CHU Jean Minjoz

Besançon, Franche-Comté, France

Service de Rhumatologie, CHU Fort de France

Fort de France, La Martinique, France

Service de Rhumatologie, Hôpitaux de Rouen

Rouen, Normandy, France

Service de Rhumatologie, APHP - CHU Bichat

Paris, Paris, France

Service de Rhumatologie, APHP - GH Pitié Salpêtrière

Paris, Paris, France

Service de Rhumatologie, CHU Conception

Marseille, , France

Fédération de Rhumatologie, CHU Lapeyronie

Montpellier, , France

Service de Rhumatologie, CHU de Poitiers

Poitiers, , France

Service de Rhumatologie, Hôpital Larey

Toulouse, , France

Countries

France

References

Fautrel B, Morel J, Berthelot JM, Constantin A, De Bandt M, Gaudin P, Maillefert JF, Meyer O, Pham T, Saraux A, Solau-Gervais E, Vittecoq O, Wendling D, Erpelding ML, Guillemin F; STPR Group of the French Society of Rheumatology. Validation of FLARE-RA, a Self-Administered Tool to Detect Recent or Current Rheumatoid Arthritis Flare. Arthritis Rheumatol. 2017 Feb;69(2):309-319. doi: 10.1002/art.39850.

Reference Type: DERIVED

PMID: 27636400 (View on PubMed)

Other Identifiers

2011-A01349-32

Identifier Type: -

Identifier Source: org_study_id