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FIrst-line Rituximab in Systemic lupus erythematosus Trial (FIRST):  

A multicentre, double-blind, randomised, placebo-controlled, superiority trial with an internal pilot and cost effectiveness analysis to determine if early treatment with rituximab in moderate/severe lupus is superior to usual care.

Study Aim: To determine the clinical and cost-effectiveness of rituximab (RTX) given first-line or after failure of conventional immunosuppressants in people with early moderate to severe SLE.

Background: SLE is a life-long autoimmune disease that causes inflammation and damage to a range of organs. It is more severe in children and people of non-European ancestries. Current practice is to treat SLE with a series of conventional immunosuppressants combined with glucocorticoids (GC), but evidence for the sequence in which they should be used is weak. Under current guidelines, if this approach fails, and people have moderate to severe SLE, a more effective therapy, RTX, can be added to these agents later as usual care. This approach may not be optimal since SLE is most severe within the first 12 months of diagnosis, with the highest mortality, GC exposure and healthcare resource use.

Design: 2-arm, double-blind, randomised (1:1):

Arm 1 (64 patients) – IV rituximab + usual care

Arm 2 (64 patients) – IV placebo + usual care.

Participants will be followed monthly for 12 months to assess disease activity, side effects, patient views and requirements of steroids or other new therapy to treat SLE. Healthcare costs will also be calculated.

Setting: 20 NHS hospitals across England

Target Population: We aim to recruit 128 in-patients and out-patients aged 5 years or older, with a new SLE diagnosis, moderate to severe disease activity, from rheumatology, renal and dermatology clinics.

Primary Outcome: Cumulative time where SLE disease activity is adequately controlled on an acceptable GC dose, defined by the Low-Level Disease Activity Score (LLDAS).

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Funding

Funders(s) NIHR HTA Project: NIHR HTA Project: NIHR167542
Start Date: April 2025
End Date: March 2029

Members

YTU Team

External Members

  • Dr Edward Vital (Co-CI) –University of Leeds
  • Dr Yuz Yusof (Co-CI) – Leeds Teaching Hospitals NHS Trust
  • Dr Eve Smith – University of Liverpool
  • Dr Elena Moraitis – Great Ormond Street Hospital for Children NHS Foundation Trust
  • Mrs Olivia Lloyd – Alder Hey Children’s NHS Foundation Trust
  • Ms Amy Rebane – University of Leeds
  • Mrs Jenny Ainsworth – University of Liverpool
  • Ms Dalila Tremarias – PPI Representative based in Wales
  • Professor Ian Bruce – University of Manchester
  • Professor Mike Ehrenstein – University College London
  • Professor David Jayne – University of Cambridge
  • Sponsor (University of Leeds)

Contact Us

Email: ytu-first-trial@york.ac.uk

University of Leeds