Arthritis, RheumatoidFLARENCT01722617

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

A study testing Questionnaire in people with Arthritis, Rheumatoid, run by Central Hospital, Nancy, France at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthritis, Rheumatoid
What is being tested?: Questionnaire
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 207 participants
Where: 13 sitesFrance
Study dates: Mar 2012to Jun 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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Agreed and signed the informed consent form;
Ability to comply with the study protocol;
Having the social insurance coverage

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

France13 sites

Service de Rhumatologie, CHU Jean Minjoz
Besançon, Franche-Comté, 25030
Service de Rhumatologie, CHU La Cavale Blanche
Brest, Brittany Region, 29607
Service de Rhumatologie, CHU Hôpital Général
Dijon, Bourgogne-Franche-Comté, 21033
Service de Rhumatologie, CHU Fort de France
Fort de France, La Martinique, 97261
Service de Rhumatologie, CHU - Hôpital Sud A. Michallon
Grenoble, Auvergne-Rhône-Alpes, 38130
Service de Rhumatologie, CHU Conception
Marseille, 13385
Fédération de Rhumatologie, CHU Lapeyronie
Montpellier, 34295
Service de Rhumatologie, CHRU Hôtel Dieu
Nantes, Brittany Region, 44093
Service de Rhumatologie, APHP - CHU Bichat
Paris, Paris, 75018
Service de Rhumatologie, APHP - GH Pitié Salpêtrière
Paris, Paris, 75651
Service de Rhumatologie, CHU de Poitiers
Poitiers, 86021
Service de Rhumatologie, Hôpitaux de Rouen
Rouen, Normandy, 76233
Service de Rhumatologie, Hôpital Larey
Toulouse, 31059

Other trials in France

About this study

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

Read the 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:

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.

Conditions: Arthritis, Rheumatoid
Being tested: Questionnaire
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01722617
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 6 mois

Secondary outcomes (2)

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.
Measured: 6 mois.
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.
Measured: 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Jun 2014

First posted7 Nov 2012 (estimated)
Study startMar 2012
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01722617
Sponsor's protocol ID: 2011-A01349-32
Acronym: FLARE
Status last verified: Jan 2012
First submitted: 26 Oct 2012
Last updated: 23 Sep 2015
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 27636400

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arthritis, Rheumatoid trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Validate Questionnaires FLARE and OM-RA-FLARE Measuring Disease Flares in Patients With Rheumatoid Arthritis.
ClinicalTrials.gov ID: NCT01722617
Acronym / sponsor ID: FLARE / 2011-A01349-32
Conditions: Arthritis, Rheumatoid
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Central Hospital, Nancy, FranceUniversity, hospital or other
Collaborators: Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Régional et Universitaire de Brest, Centre Hospitalier Universitaire Dijon, University Hospital, Grenoble, University Hospital Center of Martinique, University Hospital, Montpellier, Nantes University Hospital, Bichat Hospital, Groupe Hospitalier Pitie-Salpetriere, Poitiers University Hospital, University Hospital, Rouen, University Hospital, Toulouse
Study start: Mar 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 7 Nov 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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:

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.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
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	Other: QuestionnairePatients in this group will be asked to fill basic questionnaires and FLARE questionnaires.
DAS 28+FLARE + information to doctor	Active comparator	Other: QuestionnairePatients in this group will fill basic and FLARE questionnaires which then will be transmitted to physician.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age ≥ 18 years;
Having Rheumatoid Arthritis (RA) since more than 6 months, meeting the ACR 1987 and the ACR / EULAR 2010;
Treatment of RA:
Receive the medical exam first;
Agreed and signed the informed consent form;

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QuestionnairePatients in groups 2 and 3 will be asked to fill in questionnaires FLARE.	Other	DAS 28 + FLARE questionnaires, DAS 28+FLARE + information to doctor

Primary outcome

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).

2 secondary outcomes

The discriminating power of the instrument FLARE.
Time frame: 6 mois.
The feasibility of the questionnaire FLARE
Time frame: 6 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Derived from this study: PubMed 27636400Fautrel 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.

Related trials for Arthritis, Rheumatoid

RecruitingPhase 1
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
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RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
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Not yet recruitingObservational study
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RecruitingPhase 1/2
A Study of AZD0120 in Autoimmune Diseases
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Francis Guillemin, MD, PhD principal investigator

CIC-EC Inserm, CHU de Nancy

Bruno Fautrel, MD, PhD principal investigator

Service de Rhumatologie, Groupe Hospitalier Pitié - Salpêtrière, Paris

Jacques Morel, MD, PhD principal investigator

Service d'immunorhumatologie, Hôpital Lapeyronie, Montpellier

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Questionnaire in people with Arthritis, Rheumatoid, run by Central Hospital, Nancy, France at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The validity of the questionnaire FLARE. (time frame: 6 mois). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01722617, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.