Arthritis prevention in the pre-clinical phase of RA with abatacept (the APIPPRA study): A multi-centre, randomised, double-blind, parallel-group, placebo-controlled clinical trial protocol

Maria Antonietta D'Agostino, Mariam Al-Laith, Marianna Jasenecova, Sonya Abraham, Aisla Bosworth, Ian N. Bruce, Christopher D. Buckley, Coziana Ciurtin, Maria-Antonietta D'Agostino, Paul Emery, Hill Gaston, John D. Isaacs, Andrew Filer, Benjamin A. Fisher, Thomas W. J. Huizinga, Pauline Ho, Clare Jacklin, Heidi Lempp, Iain B. Mcinnes, Arthur G. PrattAndrew Östor, Karim Raza, Peter C. Taylor, Dirkjan Van Schaardenburg, Dharshene Shivapatham, Alison J. Wright, Joana C. Vasconcelos, Joanna Kelly, Caroline Murphy, A. Toby Prevost, Andrew P. Cope

Risultato della ricerca: Contributo in rivistaArticolo in rivista

25 Citazioni (Scopus)

Abstract

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.
Lingua originaleEnglish
pagine (da-a)429-N/A
RivistaTrials
Volume20
DOI
Stato di pubblicazionePubblicato - 2019

Keywords

  • Abatacept
  • Antibodies to citrullinated protein antigens
  • Antirheumatic Agents
  • Arthritis, Rheumatoid
  • At risk
  • Autoantibodies
  • Biomarkers
  • Double-Blind Method
  • Double-blind
  • Drug Administration Schedule
  • Feasibility Studies
  • Female
  • Humans
  • Intervention
  • Male
  • Multicenter Studies as Topic
  • Netherlands
  • Placebo-controlled
  • Pre-clinical phase
  • Pregnancy
  • Randomised
  • Randomized Controlled Trials as Topic
  • Rheumatoid arthritis
  • Time Factors
  • Treatment Outcome
  • United Kingdom

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