Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis

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.

Timeline

Start

2016-10

Primary completion

2020-05-13

Completion

2020-05-13

Publications

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• Chung MP, Valenzuela A, Li S, Catanese B, Stevens K, Fiorentino D, Strand V, Chung L. A pilot study to evaluate the safety and efficacy of treprostinil in the treatment of calcinosis in systemic sclerosis. Rheumatology (Oxford). 2022 May 30;61(6):2441-2449. doi: 10.1093/rheumatology/keab810.

Drugs

Indications