Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

Summary

GRegistry is a significant collection of data and information on the clinical practice of systemic scleroderma finger ulcers.

The GRegistry study is a nationwide (Greece) prospective study recording, which includes consecutive patients with SC-DU diagnosis in clinical management departments of different hospitals, selected in such a way as to reflect a representation of the country.

The use of Bosentan in the treatment of patients suffering from systemic sclerosis with digital ulcer disease is supported by data from large, placebo-controlled, randomized studies. The beneficial effect of Bosentan in digital ulcers, a vascular event of systemic sclerosis consistent with its beneficial effect on pulmonary arterial hypertension associated with connective tissue disease and its beneficial effect on vascular remodeling.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elpen Pharmaceutical Co. Inc.
• Treatments: Bosentan

Criteria

Inclusion Criteria:

• Both genders >18 and < 80 years

• ACR 2013 criteria >9 & =9

• At least one Digital Ulcer

• Raynaud Severity Scale (0-10)

Exclusion Criteria:

• < 18 years

• ACR 2013 criteria <9