Study and Monitoring of Early Undifferentiated Arthritis

NCT03666091 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 813

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

  • Early Rheumatoid Arthritis or Early Undiffentiated Arthritis

Sponsors & Collaborators

  • Amiens University Hospital

    collaborator OTHER
  • University Hospital, Bordeaux

    collaborator OTHER
  • University Hospital, Brest

    collaborator OTHER
  • University Hospital, Lille

    collaborator OTHER
  • University Hospital, Montpellier

    collaborator OTHER
  • Saint Antoine University Hospital

    collaborator OTHER
  • Pitié-Salpêtrière Hospital

    collaborator OTHER
  • Hôpital Cochin

    collaborator OTHER
  • Bicetre Hospital

    collaborator OTHER
  • Bichat Hospital

    collaborator OTHER
  • University Hospital, Rouen

    collaborator OTHER
  • University Hospital, Strasbourg, France

    collaborator OTHER
  • University Hospital, Toulouse

    collaborator OTHER
  • University Hospital, Tours

    collaborator OTHER
  • Societe Francaise de Rhumatologie

    lead OTHER

Principal Investigators

  • Bernard COMBE, MD, PHD · Montpellier University Hospital rheumatology department

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-13
Primary Completion
2005-04-19
Completion
2025-07-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03666091 on ClinicalTrials.gov