Evidence map›Paper›PMID 41734287›Full record

Trial reportRheumatology (Oxford, England)2026

A randomised open-label pilot trial comparing mycophenolate mofetil with no immunosuppression in limited cutaneous systemic sclerosis (MINIMISE-Pilot).

Christopher P Denton, Philip Yee, Medha Kanitkar, Hannah Sims, Charlotte Clarke, Saiam Ahmed, Voon H Ong, Francesco Del Galdo, John D Pauling, Marina E Anderson and 10 more

Abstract readRandomized Controlled TrialComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Rheumatology (Oxford, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Christopher P DentonDivision of Medicine, University College London, London, UK.ORCID 0000-0003-3975-8938
Philip YeeRoyal Free London NHS Foundation Trust, London, UK.
Medha KanitkarRoyal Free London NHS Foundation Trust, London, UK.
Hannah SimsUCL Comprehensive Clinical Trials Unit, UCL Institute of Clinical Trials and Methodology, University College London, London, UK.
Charlotte ClarkeUCL Comprehensive Clinical Trials Unit, UCL Institute of Clinical Trials and Methodology, University College London, London, UK.
Saiam AhmedUCL Comprehensive Clinical Trials Unit, UCL Institute of Clinical Trials and Methodology, University College London, London, UK.
Voon H OngDivision of Medicine, University College London, London, UK.ORCID 0000-0001-5474-0053
Francesco Del GaldoLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.ORCID 0000-0002-8528-2283
John D PaulingNorth Bristol NHS Trust, Bristol, UK.ORCID 0000-0002-2793-2364
Marina E AndersonLancaster University & NHS University Hospitals of Liverpool Group, Liverpool, UK.
Muditha SamaranayakaSalford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.
Michael HughesSalford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.
Smita BhatNinewells Hospital and Medical School, Dundee, UK.
Bridget GriffithsFreeman Hospital Newcastle, Newcastle, UK.
Maya H BuchCentre for Musculoskeletal Research, University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK.ORCID 0000-0002-8962-5642
Ariane L HerrickSalford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.ORCID 0000-0003-4941-7926
David D'CruzGuy's and St Thomas' Hospitals NHS Foundation Trust, London, UK.
Madelon C VonkDepartment of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands.
Nick FreemantleUCL Comprehensive Clinical Trials Unit, UCL Institute of Clinical Trials and Methodology, University College London, London, UK.ORCID 0000-0001-5807-5740
Hakim-Moulay DehbiUCL Comprehensive Clinical Trials Unit, UCL Institute of Clinical Trials and Methodology, University College London, London, UK.

Funding

NIHR Clinical Research Network research portfolioVersus Arthritis 22398
6 · The paper itself

Abstract

objectivesMycophenolate 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.

methodsWe 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.

resultsRecruitment 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.

conclusionMINIMISE-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 registrationEudract (https://eudract.ema.europa.eu/) 2019-004139-21.

Indexed as

Immunosuppressive AgentsMycophenolic AcidScleroderma, LimitedAdultAgedDisease ProgressionFeasibility StudiesFemaleHumansMaleMiddle AgedPilot ProjectsScleroderma, DiffuseTreatment OutcomeImmunosuppressive AgentsMycophenolic Acidautoantibodycentromerefeasibility pilotimmunosuppressionlimited cutaneous systemic sclerosismycophenolate mofetiloutcome measurepatient reported outcome

Identifiers

PMID41734287
PMCPMC13032817

What Socratic holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.