Conditions: Systemic Sclerosis
Keywords: systemic sclerosis scleroderma digital ulcers vasculopathy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 115
Healthy volunteers: no

Brief summary:
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.

Detailed description:

Arms:
arm 1: Treprostinil diethanolamine sustained release tablet initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).

Interventions: intervention 1: treprostinil diethanolamine
Intervention descriptions: intervention 1: sustained release tablet; BID dosing; up to 16 mg BID

Protocol document: