Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis
Status:
Completed
Trial end date:
2020-05-13
Target enrollment:
Participant gender:
Summary
This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis
(SSc) and at least one calcinotic lesion of the hands that is palpable on physical
examination and also measureable on hand radiographs, at one single center. Each subject will
receive treprostinil orally for 12 months, and follow-up evaluations will be performed every
3 months. Our main objective is to determine whether oral treprostinil is safe, and effective
in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of
microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial
in the treatment of calcinosis in patients with SSc.