Systemic Sclerosis Clinical Trial
Official title:
Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial.
This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is at week 12, and patients will be followed up to one year after baseline
Systemic sclerosis is a disease with a high burden caused by morbidity and increased
mortality. To date a cure for SSc is not available. In this trial, patients are treated very
early in the disease which could change the long term outcome of SSc in these patients.
In daily practice, patients so early in the disease course are not treated although they
might be at risk for early escalation and internal organ involvement, reducing their
prognosis. A trial to investigate the efficacy of a relative save, inexpensive and easy
accessible treatment will provide us with the opportunity to change the disease course and
reducing the disease burden of a portion of the SSc patients
;
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