medwireNews: A EULAR taskforce has developed guidance on how to conduct clinical trials involving people at risk for rheumatoid arthritis (RA).
“It is now clear that the onset of [RA] is preceded by a complex preclinical phase,” and several clinical trials aiming to prevent RA in those with risk factors are in progress, explain Kulveer Mankia (University of Leeds, UK) and co-authors.
They note, however, that “these studies represent uncharted territory in rheumatology,” with “many important differences and unknowns” when compared with conventional trials of therapies that aim to suppress established disease.
To address these uncertainties, the taskforce conducted a systematic literature review and developed one overarching principle, 10 points to consider, and a research agenda for RA prevention trials.
In their overarching principle, Mankia and colleagues recommend that all studies involving people at risk for RA should measure epidemiologic and demographic characteristics. They also defined three distinct at-risk populations – asymptomatic; musculoskeletal symptoms without arthritis; and early clinical arthritis – and provide guidance on points including study outcomes and when to measure risk factors.
“These statements should help harmonise the datasets produced by future studies and facilitate collaboration in this important area,” concludes the team in the Annals of the Rheumatic Diseases.
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group