SISTEMIC SCLEROSIS MedDRA version: 20.0 Level: LLT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA
Product Name: ENDOPROST
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ILOPROST
Sponsors
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: •Patients’ Quality of Life, measured with the HAQ ( Health Assessment Questionnaire •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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactCRO ACCADEMICA
CLINICAL TRIAL CENTER
Outcome results
None listed