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Clinical trials in rheumatoid arthritis (RA) involve assessment of response by endpoints including composite measures of disease activity. However, many of the components are subjective and insensitive to change and their use in phase III studies necessitates large and costly trials.
In single-centre, or two-centre RA studies, Greyscale ultrasound (GSUS) and power Doppler ultrasound (PDUS) imaging of a limited joint set is an early and reliable indicator of therapeutic response.1–3 However, use of ultrasound (US) endpoints in multicentre clinical trials presents challenges of operator-dependency and variability in image acquisition, even when using the same model and settings of US machine.
We undertook an exploratory multicentre, US substudy, nested within the SIRROUND-H trial,4 to evaluate effects of sirukumab and adalimumab on synovial thickness and vascularity by GSUS and PDUS, respectively, in 41 consenting subjects (online supplementary Table S1) at nine clinical sites. At each site, ultrasonographers blinded to treatment assessed 12 joints (10 metacarpophalangeal (MCP) joints plus wrists) at Weeks 0, 2, 4, 8 and 24. The same model LOGIQ S8 RD US …
Handling editor Josef S Smolen
Contributors All authors meet the journal’s criteria for authorship. All authors have contributed to the work and approve the presented findings.
Funding This study was funded by Janssen Research & Development.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study protocols were reviewed and approved by an independent ethics committee or institutional review board for each study centre. This study is registered at EudraCT (number: 2013-001417-32) and ClinicalTrials.gov (number: NCT02019472).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data are included in this letter and attached tables and figures.
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