Systemic sclerosis & Raynaud's
A randomised open-label pilot trial comparing mycophenolate mofetil with no immunosuppression in limited cutaneous systemic sclerosis (MINIMISE-Pilot)
- Terminated early due to low recruitment
Authors' conclusion
MINIMISE-Pilot achieved its goal as a feasibility trial, leading to early termination of the study due to low recruitment.
Study context
- Population
- Patients with lcSSc53 screened
- Participants
- 43 patients
- Comparison
- Mycophenolate mofetil (MMF) vs no immunosuppression
- MMFn = 21
- Primary endpoint
- Feasibility of an open-label event-driven RCT of MMF vs no immunosuppression in lcSSc (prespecified Stop-Go criteria for continuation)
Methodological detailsopen-label, pilot, feasibility, event-driven, prespecified Stop-Go criteria, stratified by ACA status, 12 sites in the UK
- Open-label
- Pilot
- Feasibility
- Event-driven
- Prespecified Stop-Go criteria
- Stratified by ACA status
- 12 sites in the UK
Primary result
As reported in the abstract
Feasibility (recruitment)
- Recruitment <60 participants; trial terminated on the prespecified threshold for continuation
- Recruitment was challenging
Further findings
- 100% adherence to MMF · week 1
- 95% · 19
- 100% adherence to MMF · week 24
- 64% · 9
Clinical worsening endpoints (MINIMISE composite) during treatment period
- No clinical worsening endpoints
Original publication
A randomised open-label pilot trial comparing mycophenolate mofetil with no immunosuppression in limited cutaneous systemic sclerosis (MINIMISE-Pilot). Rheumatology (Oxford). Published 24 February 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →