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Clinical Trial Summary

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


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03059979
Study type Interventional
Source Radboud University
Contact Sjoukje Mulder
Phone +31 24 3619398
Email sjoukje.mulder@radboudumc.nl
Status Recruiting
Phase Early Phase 1
Start date January 2017
Completion date July 1, 2021

See also
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