Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis (GRegistry SCDU)

A National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment.

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.

Study Overview

• Status: Completed
• Conditions: Scleroderma; Digital Ulcer; Systematic Sclerosis
• Intervention / Treatment: Drug: Bosentan group

Detailed Description

The existence and use of Patient Registries, represents one of the foundations of the progressing medical science, both for studying the natural history of diseases as well as to critically evaluate the therapeutic methods, the collection and analysis of the data from a large number of hospital units, is essential. Furthermore, the assessment of the effectiveness and adequacy of health services should be based on long-term monitoring of large groups of patients, and the assessment of the efficient functioning of the individual units, is only possible only with the availability of information for the patients of these units.

Moreover, the record of health services distribution data is a prerequisite for the design of their future development. The above led to growth of many national and international patient logs, diseases and specific treatments, the operation of which has contributed to the advancement of medical science.

Scleroderma or Systemic Sclerosis (SC) is a chronic autoimmune disease of the connective tissue with an incidence of 1: 10000- 1: 30000. In Greece it is estimated that there are approximately 2,500 patients. The disease usually affects women aged 40-60 years, and the incidence is four women to one man. The pathogenesis of the disease is unknown, while the main causes are considered genetic and environmental factors.

Two of the most critical complications of the disease, are the Pulmonary Arterial Hypertension, which occurs in patients with SC approximately 8-12% of patients, being the main cause of death, and digital ulcers that occur in 30-60 % of patients and are painful sores on the fingers. Digital ulcers, i.e. painful sores on the fingers, as a consequence of the limited blood supply of vessels are seen in approximately 30-60 % of patients with scleroderma. The digital ulcers adversely affect the quality of life of patients, even the simple daily activities and can lead to serious complications, such as amputation. The symptoms of scleroderma can vary between patients and may not be typical of this disease, at least in the early stages, making it difficult to diagnose. Two of the early symptoms are disturbance of blood supply to the extremities by a color change of the skin of the fingers, alternately pallor-cyanation-redness (Raynaud phenomenon) and rigid edematous fingers.

• Study Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • University Clinic, Laiko Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Digital Ulcers caused by Systematic Scleroderma according to ACR 2013 criteria

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reynaud Severity Scale		4 months
Number of Ulcers		4 months
Modified Rodnan Skin Score - MRSS		4 months
Complications of systems	Number of organic systems which are affected by Systematic Scleroderma within last 4 months	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	4 months

Collaborators and Investigators

• Sponsor: Elpen Pharmaceutical Co. Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: June 3, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Sclerosis; Ulcer; Skin Ulcer; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Endothelin Receptor Antagonists; Bosentan
• Other Study ID Numbers: 2016-BSN-EL-64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED