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Lookup NU author(s): Dr Bridget Griffiths
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© The Author(s) 2026. Published by Oxford University Press on behalf of the British Society for Rheumatology. OBJECTIVES: Mycophenolate mofetil (MMF) is routinely used in early diffuse cutaneous systemic sclerosis (dcSSc) but not in limited cutaneous (lc)SSc. This may miss an opportunity to slow disease progression. MINIMISE-Pilot tested the feasibility of an open-label event-driven randomised trial of MMF vs no immunosuppression in lcSSc. METHODS: We tested the feasibility of a trial evaluating the impact of MMF on a novel event-driven composite endpoint. The MINIMISE endpoint measures time to worsening of lcSSc determined by progressive lung fibrosis, pulmonary hypertension, scleroderma renal crisis, heart failure, severe gut involvement, major digital vascular complications or death. Prespecified 'Stop-Go' criteria were agreed. Subjects were stratified by ACA status. RESULTS: Recruitment was challenging. A total of 53 subjects were screened and 43 were randomised, 21 to the MMF arm. Since recruitment was <60 participants, MINIMISE-Pilot was terminated based upon the prespecified threshold for continuation. During the treatment period there were no clinical worsening endpoints. Adherence to MMF was generally high, with 19 participants (95%) being 100% adherent at week 1, decreasing to 9 participants (64%) at week 24. CONCLUSION: MINIMISE-Pilot achieved its goal as a feasibility trial, leading to early termination of the study due to low recruitment. The rationale and concept for this study remain very strong. However, our findings suggest that a randomised prospective trial across 12 sites in the UK with relatively short follow-up duration is not feasible. This will inform the design of future studies testing the benefit of MMF in lcSSc. TRIAL REGISTRATION: Eudract (https://eudract.ema.europa.eu/) 2019-004139-21.
Author(s): Denton CP, Yee P, Kanitkar M, Sims H, Clarke C, Ahmed S, Ong VH, Del Galdo F, Pauling JD, Anderson ME, Samaranayaka M, Hughes M, Bhat S, Griffiths B, Buch MH, Herrick AL, D'Cruz D, Vonk MC, Freemantle N, Dehbi H-M
Publication type: Article
Publication status: Published
Journal: Rheumatology
Year: 2026
Volume: 65
Issue: 3
Print publication date: 01/03/2026
Online publication date: 24/02/2026
Acceptance date: 27/01/2026
Date deposited: 13/04/2026
ISSN (electronic): 1462-0332
Publisher: Oxford University Press
URL: https://doi.org/10.1093/rheumatology/keag108
DOI: 10.1093/rheumatology/keag108
Data Access Statement: Appropriate data from this study can be made available for academic research upon reasonable request to the corresponding author.
PubMed id: 41734287
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