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Sirukumab and adalimumab reduce power Doppler ultrasound signal in patients with rheumatoid arthritis by 4 weeks in a phase III trial
  1. Kristen Sweet1,
  2. Bidisha Dasgupta2,
  3. Dick de Vries2,
  4. Ian Gourley2,
  5. Benjamin Hsu2,
  6. Matthew J Loza3,
  7. Peter C Taylor4
  1. 1 Janssen Research & Development, Spring House, Pennsylvania, USA
  2. 2 Janssen Research & Development, Ambler, Pennsylvania, USA
  3. 3 Janssen Research & Development, LLC, Spring House, Pennsylvania, USA
  4. 4 Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK
  1. Correspondence to Professor Peter C Taylor, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford OX3 7LD, UK; peter.taylor{at}kennedy.ox.ac.uk

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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 …

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