EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis

Research output: Contribution to journalArticlepeer-review

Authors

  • Kulveer Mankia
  • Heidi J. Siddle
  • Andreas Kerschbaumer
  • Deshire Alpizar Rodriguez
  • Anca Irinel Catrina
  • Juan D. Cañete
  • Andrew P Cope
  • Claire Immediato Daien
  • Kevin D. Deane
  • Hani El-Gabalawy
  • Axel Finckh
  • V. Michael Holers
  • Marios Kouloumas
  • Francesca Ometto
  • Codruta Zabalan
  • Annette H M van der Helm-van Mil
  • Dirkjan van Schaardenburg
  • Daniel Aletaha
  • Paul Emery

Colleges, School and Institutes

External organisations

  • Leeds Teaching Hospitals NHS Trust
  • Medical University of Vienna
  • Colegio Mexicano de Reumatología, Mexico City
  • Karolinska University Hospital
  • Universitat de Barcelona
  • Univ Montpellier
  • University of Colorado
  • EULAR, Kilchberg
  • University of Padova
  • Imperial College London
  • University of Leeds
  • University of Manitoba
  • University of Geneva
  • Leiden University Medical Center - LUMC
  • Erasmus Medical Center
  • Sandwell and West Birmingham Hospitals NHS Trust
  • Amsterdam UMC
  • Amsterdam Rheumatology and Immunology Center

Abstract

Background: Despite growing interest, there is no guidance or consensus on how to conduct clinical trials and observational studies in populations at-risk of rheumatoid arthritis (RA).

Methods: A European League Against Rheumatism (EULAR) task force formulated four research questions to be addressed by systematic literature review (SLR). The SLR results informed consensus statements. One over-arching principle, 10 points to consider (PTC) and a research agenda were proposed. Task force members rated their level of agreement (1-10) for each PTC.

Results: Epidemiological and demographic characteristics should be measured in all clinical trials and studies in at-risk individuals. Different at-risk populations, identified according to clinical presentation, were defined; asymptomatic, musculoskeletal (MSK) symptoms without arthritis and early clinical arthritis. Study end-points should include the development of subclinical inflammation on imaging, clinical arthritis, RA, and subsequent achievement of arthritis remission. Risk factors should be assessed at baseline, and re-evaluated where appropriate; they include genetic markers and autoantibody profiling and additionally clinical symptoms and subclinical inflammation on imaging in those with symptoms and/or clinical arthritis. Trials should address the effect of the intervention on risk factors, as well as progression to clinical arthritis or RA. In patients with early clinical arthritis, pharmacological intervention has the potential to prevent RA development. Participants’ knowledge of their RA risk may inform their decision to participate; information should be provided using an individually tailored approach.

Conclusion: These consensus statements provide data-driven guidance for rheumatologists, health professionals and investigators conducting clinical trials and observational studies in individuals at-risk of RA.

Details

Original languageEnglish
JournalAnnals of the Rheumatic Diseases
Early online date6 Aug 2021
Publication statusE-pub ahead of print - 6 Aug 2021