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

NCT01722617 | Completed

• 1 other identifier: 2011-A01349-32
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 13

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

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The discriminating power of the instrument FLARE.

  6 mois.

• The feasibility of the questionnaire FLARE

  6 months.

Study Arms (3)

DAS 28

NO INTERVENTION

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

DAS 28 + FLARE questionnaires

ACTIVE COMPARATOR

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

Other: Questionnaire

DAS 28+FLARE + information to doctor

ACTIVE COMPARATOR

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

Other: Questionnaire

Interventions

Questionnaire OTHER

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

DAS 28 + FLARE questionnaires; DAS 28+FLARE + information to doctor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients undergoing surgery during the study period;
• Patients without any affiliation to a social security coverage (or entitled beneficiary);
• Patients under guardianship or trusteeship.

Sponsors & Collaborators

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

Study Sites (13)

Service de Rhumatologie, CHU - Hôpital Sud A. Michallon

Grenoble, Auvergne-Rhône-Alpes, 38130, France

Location

Service de Rhumatologie, CHU Hôpital Général

Dijon, Bourgogne-Franche-Comté, 21033, France

Location

Service de Rhumatologie, CHU La Cavale Blanche

Brest, Brittany Region, 29607, France

Location

Service de Rhumatologie, CHRU Hôtel Dieu

Nantes, Brittany Region, 44093, France

Location

Service de Rhumatologie, CHU Jean Minjoz

Besançon, Franche-Comté, 25030, France

Location

Service de Rhumatologie, CHU Fort de France

Fort de France, La Martinique, 97261, France

Location

Service de Rhumatologie, Hôpitaux de Rouen

Rouen, Normandy, 76233, France

Location

Service de Rhumatologie, APHP - CHU Bichat

Paris, Paris, 75018, France

Location

Service de Rhumatologie, APHP - GH Pitié Salpêtrière

Paris, Paris, 75651, France

Location

Service de Rhumatologie, CHU Conception

Marseille, 13385, France

Location

Fédération de Rhumatologie, CHU Lapeyronie

Montpellier, 34295, France

Location

Service de Rhumatologie, CHU de Poitiers

Poitiers, 86021, France

Location

Service de Rhumatologie, Hôpital Larey

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 27636400 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: November 7, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 23, 2015

Record last verified: 2012-01

Locations

FR (13)