Mycophenolate in Limited Cutaneous Systemic Sclerosis (MINIMISE-Pilot)
Status:
Not yet recruiting
Trial end date:
2024-02-28
Target enrollment:
Participant gender:
Summary
Systemic sclerosis or scleroderma is an autoimmune condition that cause thickening and
hardening of the skin, but can also affect internal organs. There are two major subsets of
scleroderma: the limited cutaneous systemic sclerosis (lcSSc) that usually affects the skin
of the face, neck, lower legs or lower arms, but can also lead to internal organ
complications, and the diffuse cutaneous systemic sclerosis (dcSSc) that may affect blood
circulation and internal organs, as well as the skin. To date there is no drug that has been
definitively proven to cure or modify the course of scleroderma. However, there is emerging
evidence that immunosuppression and specifically mycophenolate mofetil (MMF) may be
beneficial in lcSSc.
The MINIMISE-Pilot trial would be an important first step to evaluate the risk and potential
benefit to this disease group. MMF as the intervention of choice is both appropriate and
timely, as it has been routinely used in the management of dcSSc. The aim of this pilot trial
is to explore whether the immunosuppressive agent MMF can slow down disease progression in
patients with lcSSc compared to the current standard of care alone. This pilot trial will
also provide critical information for the development of a future large trial that could
potentially transform lcSSc patient management.