D

Phase 1

• Conditions: SISTEMIC SCLEROSIS; MedDRA version: 20.0Level: LLTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-002984-32-IT
• Lead Sponsor: IVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-05
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

1.Informed Consent personally signed and dated by the patient, before any study procedure is implemented
2.Diagnosis of Raynaud’ Disease, with or without presence of acral ulcers
3.Age = 18 and = 80 years
4.Check for proper venous assets (rated by experienced personnel) or central venous access
5.Women of childbearing potential not willing to become pregnant during the course of the study and for 1 month following its completion
6. Men having a relationship with women of childbearing age, who are willing not to get pregnant during the course of the study and for 1 month following its completion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

1.Patients with a disease characterized by advanced stages of deformation
2.Contraindications to treatment with Iloprost and / or hypersensitivity to the active substance or to any of the excipients (trometamol, ethanol, 96% (v / v), sodium chloride, hydrochloric acid)
3.Chronic renal failure (GFR <30 ml / min
4.Liver Cirrhosis
5.Surgery planned or executed by less than 3 months after initiation of treatment to the central nervous system and / or the eye; trauma surgery associated with large wounds exposed
6.Severe Thrombocytopenia (PLT <20,000 / mmc) or severe anemia (Hb <8 g / dl)
7.Severe and not controlled arterial hypertension
8.Orthostatic hypotension
9.Cephalalgia type of pathology and / or chronic vertigo evaluated by a reference specialist and / or for which the patient is undergoing a drug treatment
10.Gastrointestinal pathology in acute phase
11.Pregnancy and / or breast-feeding
12.Severe coronary heart disease or unstable angina, myocardial infarction within six months preceding the start of treatment, acute or chronic congestive heart failure (NYHA II - IV), severe arrhythmias or relevant for prognosis
13.Severe ischemic disorders of the lower limbs (grade III and IV)
14.Smoking Patients with high levels of daily consumption and not willing to abstain during the treatment period
15.Severe coagulation disorders, who need a stable regimen of treatment with anticoagulants or platelet aggregation inhibitors
16.Patients with a neurological condition that makes them incapable of understanding the nature, purpose and possible consequences of the study
17.Congestive heart failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the efficacy, the safety and the feasibility of the slow infusion of Iloprost done at home, using the portable syringe pump INFONDE® in a group of patients affected by systemic sclerosis.<br>;Secondary Objective: •Patients’ Quality of Life, measured with the HAQ ( Health Assessment Questionnaire<br>•Pharmacoeconomic assessments, related to the probable resources savings (direct and indirect costs), linked to the treatment made at home.;Primary end point(s): Raynaud’s Disease intensity, evaluated through the Raynaud’s Condition Score (RCS);Timepoint(s) of evaluation of this end point: 18 MONTHS

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ?Ischemic ulcers incidence observed at 6 months of follow-up ?Recovery time of the observed ischemic ulcers ?Frequency and duration of the Raynaud’s Disease, evaluated through the Raynaud’s Condition Score (RCS) ?Patients’ Quality of Life, measured with the HAQ ( Health Assessment Questionnaire ?Completion rate of the entire home infusion cycle ?Adverse Events incidence;Timepoint(s) of evaluation of this end point: 18 MONTHS