Clinical trial NCT03666091: Study and Monitoring of Early Undifferentiated Arthritis
Official title: Etude et Suivi Des POlyarthrites Indifférenciées Récentes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Early Rheumatoid Arthritis or Early Undiffentiated Arthritis
Keywords: ESPOIR cohort RA Early Undifferentiated Arthritis
Lead sponsor: Societe Francaise de Rhumatologie
Sponsor class: OTHER
Collaborators: name: Amiens University Hospital
name: University Hospital, Bordeaux
name: University Hospital, Brest
name: University Hospital, Lille
name: University Hospital, Montpellier
name: Saint Antoine University Hospital
name: Pitié-Salpêtrière Hospital
name: Hôpital Cochin
name: Bicetre Hospital
name: Bichat Hospital
name: University Hospital, Rouen
name: University Hospital, Strasbourg, France
name: University Hospital, Toulouse
name: University Hospital, Tours
First posted: 2018-09-11
Enrollment: 813
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 814 patients with early arthritis were included be- tween November 2002 and april 2005.One patient removed his consent form. All the centres were active and each regional centre recruited between 35 and 83 patients.

Brief summary: The French Society of Rheumatology initiated a large national multicenter, longitudinal and prospective cohort, ESPOIR, in order to set up databases to allow various investigations on diagnosis, prognostic markers, epidemiology, pathogenesis and medico-economic factors in the field of early arthritis and rheumatoid arthritis.

The primary objective is to set-up a multicentre cohort of early arthritis (less than 6 months) in France that could serve as a database to studies of various natures.

Specific objectives are in the following domains:

* diagnosis: to help determine among clinical, biological, radiographic and immunogenetics those parameters allowing for the earliest diagnosis classification as possible, in order to target early therapy;
* prognosis: to identify early those patients at risk of severe disease by investigating among clinical, biological, genetic and sociologic factors;
* medico-economic: to identify the costs and their determinants at various disease stage;
* pathologic: to collect a databank of sera, DNA, RNA to allow for studies of transcriptomes and other genomics.

Secondary objectives are twofold:

* to monitor adverse events, particularly rare drug adverse events, in collaboration with other international studies
* to allow access to the data collected in this cohort study in order to facilitate new projects submitted to and approved by the scientific committee.

Detailed description: All patients were referred to each regional center every 6 months during the first 2 years, then every year. Procedures were set up to avoid patients lost to followup as much as possible. At baseline and at each visit, we recorded data for a set of clinical and biological variables recommended for the management of early arthritis. At each visit, rheumatoid arthritis was classified according to the 1987 American College of Rheumatology (ACR) criteria and retrospectively to the 2010 ACR/European League Against Rheumatism (EULAR) criteria.

At each visit, patients completed function and quality-of-life self-administered questionnaires including the Health Assessment Questionnaire-Disability Index (HAQ-DI), Arthritis Impact Measurement Scales version 2 short form, a medico economic questionnaire, and globally assessed disease, pain at rest and pain during motion on a visual analog scale (VAS). Patients underwent radiographs of the hand and wrist (face) and foot (face and oblique). Radiographs were stored in the radiological coordinating center (Brest) and then were evaluated by the van der Heijde-modified Sharp score. Serum, DNA, urine, were collected at baseline. Serum and urine were also obtained at each follow-up visit. They were then sent and stored in adequate and definite conditions in the biological coordinating centre (Paris-Bichat).

Eligibility criteria: Inclusion Criteria:

* patients aged over 18 and under 70
* clinical diagnosis of rheumatoid arthritis as certain or probable
* clinical diagnosis of undifferentiated arthritis potentially becoming rheumatoid arthritis
* at least 2 inflammatory joints since 6 weeks : a swollen joint has to be observed in two articular sites and be present since at least 6 weeks
* arthritis starting since less than 6 months
* never prescribed DMARDS, corticoids, except if less than 2 weeks or except intra-articular injection less than 6 weeks before inclusion
* corticosteroids could be tolerated if prescribed for duration less than 2 weeks in the month before the inclusion with an average dose less than 20 mg per day and stopped two weeks before inclusion

Exclusion Criteria:

* patients aged less than 18 years or aged more than 70 years
* pregnant women
* undifferentiated rheumatism with no potential chance to become rheumatoid arthritis
* other inflammatory rheumatisms clearly defined

Primary outcomes:
measure: Remaining in the cohort.
timeFrame: 20 years
measure: Prescription of synthetic or biologic disease-modifying antirheumatic drugs (DMARD).
timeFrame: 20 years
measure: Patient disability evaluation.
timeFrame: 20 years
measure: Change in Disease Activity (levels of activity or remission)
timeFrame: 20 years
measure: Quality of life assessed by EQ-5D-3L/ EUROQOL
timeFrame: 20 years
measure: Quality of life assessed by MOS-SF-36/ MOS 36-Item Short-Form Health Survey
timeFrame: 15 years (from baseline to 15 years)
measure: Quality of life assessed by AIMS2-SF/Arthritis Impact Measurement Scales 2 Short Form
timeFrame: 14 years (from baseline to 14 years)
measure: Radiographic damage evaluation
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Montpellier University Hospital rheumatology department
name: Bernard COMBE, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vittecoq O, Guillou C, Hardouin J, Gerard B, Berenbaum F, Constantin A, Rincheval N, Combe B, Lequerre T, Cosette P. Validation in the ESPOIR cohort of vitamin K-dependent protein S (PROS) as a potential biomarker capable of predicting response to the methotrexate/etanercept combination. Arthritis Res Ther. 2022 Mar 21;24(1):72. doi: 10.1186/s13075-022-02762-5.
citation: Kumaradev S, Roux C, Sellam J, Perrot S, Pham T, Dugravot A, Molto A. Socio-demographic determinants in the evolution of pain in inflammatory rheumatic diseases: results from ESPOIR and DESIR cohorts. Rheumatology (Oxford). 2022 Apr 11;61(4):1496-1509. doi: 10.1093/rheumatology/keab562.
citation: Roubille C, Coffy A, Rincheval N, Dougados M, Flipo RM, Daures JP, Combe B. Ten-year analysis of the risk of severe outcomes related to low-dose glucocorticoids in early rheumatoid arthritis. Rheumatology (Oxford). 2021 Aug 2;60(8):3738-3746. doi: 10.1093/rheumatology/keaa850.
citation: Valdeyron C, Soubrier M, Pereira B, Constantin A, Morel J, Gaudin P, Combe B, Gremeau AS, Dejou-Bouillet L, Pouly JL, Sapin V, Oris C, Brugnon F. Impact of disease activity and treatments on ovarian reserve in patients with rheumatoid arthritis in the ESPOIR cohort. Rheumatology (Oxford). 2021 Apr 6;60(4):1863-1870. doi: 10.1093/rheumatology/keaa535.
citation: Mouterde G, Gamon E, Rincheval N, Lukas C, Seror R, Berenbaum F, Dupuy AM, Daien C, Daures JP, Combe B. Association Between Vitamin D Deficiency and Disease Activity, Disability, and Radiographic Progression in Early Rheumatoid Arthritis: The ESPOIR Cohort. J Rheumatol. 2020 Nov 1;47(11):1624-1628. doi: 10.3899/jrheum.190795. Epub 2019 Dec 15.
citation: Lukas C, Mary J, Debandt M, Daien C, Morel J, Cantagrel A, Fautrel B, Combe B. Predictors of good response to conventional synthetic DMARDs in early seronegative rheumatoid arthritis: data from the ESPOIR cohort. Arthritis Res Ther. 2019 Nov 15;21(1):243. doi: 10.1186/s13075-019-2020-x.