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NCT03666091Completed

Study and Monitoring of Early Undifferentiated Arthritis

Etude et Suivi Des POlyarthrites Indifférenciées Récentes

Source: ClinicalTrials.gov · Last updated 26 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
813 (actual)
First submitted
31 Aug 2018
Start date
13 Nov 2002
Primary completion date
19 Apr 2005
Lead sponsor
Societe Francaise de Rhumatologie
NCT number
NCT03666091

What you commit to

  • Study type: Observational
  • Participants enrolled: 813
  • From 13 Nov 2002 to the primary completion date, 19 Apr 2005
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • patients aged less than 18 years or aged more than 70 years

Other

  • pregnant women
  • undifferentiated rheumatism with no potential chance to become rheumatoid arthritis
  • other inflammatory rheumatisms clearly defined

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

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This page is information, not medical advice. Discuss any trial with your doctor.