Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.

Launched by ELPEN PHARMACEUTICAL CO. INC. · Dec 9, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a medication called Bosentan in treating painful open sores on the fingers and toes, known as digital ulcers, in patients with scleroderma. Scleroderma is a condition that can cause the blood vessels to narrow, leading to reduced blood flow and resulting in these hard-to-heal sores. The goal of the study is to find out if Bosentan can help improve the healing of these ulcers and enhance the quality of life for those affected.

To participate in this trial, you need to be an adult diagnosed with scleroderma and have at least one digital ulcer. You should also be currently taking Bosentan, which is a medication used to help improve blood flow. If you decide to join, you will be closely monitored and may receive additional support to manage your condition. This trial is currently recruiting participants of all genders and is an important step in finding better treatments for people suffering from this painful issue.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients
• • Patients diagnosed with scleroderma (diffuse or limited)
• • Patients with at least one digital ulcer, whether or not it is due to scleroderma
• • Patients with 2013 ACR / EULAR Classification Criteria with a total score of ≥ 9
• • Patients already taking Bosentan (Klimurtan®)
• • Patients who will sign the consent form for their participation in the study
• Exclusion Criteria:
• • Patients with digital ulcers of other etiology, other than scleroderma
• • Patients with severe pulmonary arterial hypertension (severe PAH- Category 3-4 according to WHO)
• • Patients who do not meet the criteria for taking the study drug, according to the Summary of Product Characteristics