EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis
Annals of the Rheumatic Diseases, vol. 80, pp. 1286–1298
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: An 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 overarching 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 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.
Authors 20
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Kulveer Singh Mankia corresponding
University of Leeds · NIHR Leeds Musculoskeletal Biomedical Research Unit
Affiliation as printed
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK k.s.mankia@leeds.ac.uk
NIHR Leeds Musculoskeletal Biomedical Research Centre, Leeds, UK
University of Leeds Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK
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University of Leeds · NIHR Leeds Musculoskeletal Biomedical Research Unit
Affiliation as printed
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
NIHR Leeds Musculoskeletal Biomedical Research Centre, Leeds, UK
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Affiliation as printed
Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria
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Affiliation as printed
Research Unit, Mexican College of Rheumatology, Coyoacan, Mexico
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Affiliation as printed
Rheumatology Unit, -, Stockholm, Sweden
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Hospital Clínic de Barcelona · Consorci Institut D'Investigacions Biomediques August Pi I Sunyer
Affiliation as printed
Department of Rheumatology, Arthritis Unit, Hospital Clinic and IDIBAPS, Barcelona, Spain
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Affiliation as printed
Faculty of Life Sciences and Medicine, Centre for Rheumatic Diseases, King's College London, London, UK
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Centre National de la Recherche Scientifique · Inserm · Université de Montpellier · Physiologie et Médecine Expérimentale du Coeur et des Muscles · Centre Hospitalier Universitaire de Montpellier
Affiliation as printed
Department of Rheumatology, CHU de Montpellier, University of Montpellier, PhyMedExp, INSERM, CNRS UMR, Montpellier, France
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University of Colorado Anschutz
Affiliation as printed
Division of Rheumatology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
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Affiliation as printed
Department of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
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Affiliation as printed
Division of Rheumatology, University of Geneva, Geneva, Switzerland
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University of Colorado Anschutz · University of Colorado Denver
Affiliation as printed
Division of Rheumatology, Department of Medicine, University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado, USA
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European League Against Rheumatism
Affiliation as printed
EULAR PARE, Kilchberg, Switzerland
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Affiliation as printed
Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy
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Sandwell & West Birmingham Hospitals NHS Trust · University of Birmingham
Affiliation as printed
Centre for Musculoskeletal Ageing Research and Research into Inflammatory Arthritis, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK
Department of Rheumatology, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK
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European League Against Rheumatism
Affiliation as printed
EULAR PARE, Kilchberg, Switzerland
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Annette H M van der Helm–van Mil Aachen Department of Rheumatology, Leiden University Medical Center
Leiden University Medical Center · Erasmus MC
Affiliation as printed
Department of Rheumatology, Erasmus Medical Center, Rotterdam, The Netherlands
Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Reade · Amsterdam University Medical Centers
Affiliation as printed
Department of Rheumatology, Academic Medical Center, Amsterdam UMC, Amsterdam, The Netherlands
Department of Rheumatology, Reade, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands
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Affiliation as printed
Department of Rheumatology, Medical University of Vienna, Vienna, Austria
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University of Leeds · Leeds Teaching Hospitals NHS Trust · NIHR Leeds Musculoskeletal Biomedical Research Unit
Affiliation as printed
Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK
NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK
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