This is a randomised placebo-controlled study of moderate dose prednisolone for 6 months in
patients with early diffuse cutaneous systemic sclerosis (dcSSc). Seventy-two patients within
3 years of the onset of skin thickening will be recruited from 14 UK centres over 3 years.
Co-primary end-points will be the Health Assessment Questionnaire Disability Index (HAQ-DI)
and the modified Rodnan skin score (mRSS). Patients will be assessed 5 times: screening,
baseline, 6 weeks, 3 and 6 months, with a code-break on exit from the study at 6 months.
Please note: From August 2020, the trial was re-started following halt due to Covid-19 as
open-label. The placebo arm is the 'no treatment' arm and there is no longer a code-break at
study exit.