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Lookup NU author(s): Professor John IsaacsORCiD, Dr Arthur PrattORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2019 The Author(s).Trial design: We present a study protocol for a multi-centre, randomised, double-blind, parallel-group, placebo-controlled trial that seeks to test the feasibility, acceptability and effectiveness of a 52-week period of treatment with the first-in-class co-stimulatory blocker abatacept for preventing or delaying the onset of inflammatory arthritis. Methods: The study aimed to recruit 206 male or female subjects from the secondary care hospital setting across the UK and the Netherlands. Participants who were at least 18 years old, who reported inflammatory sounding joint pain (clinically suspicious arthralgia) and who were found to be positive for serum autoantibodies associated with rheumatoid arthritis (RA) were eligible for enrolment. All study subjects were randomly assigned to receive weekly injections of investigational medicinal product, either abatacept or placebo treatment over the course of a 52-week period. Participants were followed up for a further 52 weeks. The primary endpoint was defined as the time to development of at least three swollen joints or to the fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA using swollen but not tender joints, whichever endpoint was met first. In either case, swollen joints were confirmed by ultrasonography. Participants, care givers, and those assessing the outcomes were all blinded to group assignment. Clinical assessors and ultrasonographers were also blinded to each other's assessments for the duration of the study. Conclusions: There is limited experience of the design and implementation of trials for the prevention of inflammatory joint diseases. We discuss the rationale behind choice and duration of treatment and the challenges associated with defining the "at risk" state and offer pragmatic solutions in the protocol to enrolling subjects at risk of RA. Trial registration: Current Controlled Trials, ID: ISRCTN46017566. Registered on 4 July 2014.
Author(s): Al-Laith M, Jasenecova M, Abraham S, Bosworth A, Bruce IN, Buckley CD, Ciurtin C, D'Agostino M-A, Emery P, Gaston H, Isaacs JD, Filer A, Fisher BA, Huizinga TWJ, Ho P, Jacklin C, Lempp H, McInnes IB, Pratt AG, Ostor A, Raza K, Taylor PC, Van Schaardenburg D, Shivapatham D, Wright AJ, Vasconcelos JC, Kelly J, Murphy C, Prevost AT, Cope AP
Publication type: Article
Publication status: Published
Journal: Trials
Year: 2019
Volume: 20
Issue: 1
Online publication date: 15/07/2019
Acceptance date: 06/05/2019
Date deposited: 29/07/2019
ISSN (print): 1745-6215
Publisher: BioMed Central Ltd.
URL: https://doi.org/10.1186/s13063-019-3403-7
DOI: 10.1186/s13063-019-3403-7
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