A 24-weeks , national, multicenter, double blind controlled vs placebo trial to evaluate the efficacy of Neoral ciclosporine 5mg/kg/day , twice a week administered in reduction of the rate of relapse in pz with chronic plaque psoriasis on remission. PREWENT Study - PREWENT Study
- Conditions
- Chronic plaque psoriasis on remissionMedDRA version: 6.1Level: PTClassification code 10037153
- Registration Number
- EUCTR2006-000207-42-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 264
XXXX18 Age 65 years; Patients with chronic plaque psoriasis on remission PASI 8804;75 of PASI before Neoral treatment course after a treatment course with Neoral given continuously for 8 but 16 weeks;
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients on remission after a treatment course with other drugs than Neoral Body weight 110 kg; Patients with abnormal renal function creatinine 10 UNL Patients with severe chronic degenerative diseases Severe uncontrolled hypertension Severe uncontrolled hyperlipidemia Bilirubin or liver enzymes 2 the UNL; Platelets count 75,000 mm3 with neutrophils 1,500 mm3 and/or leucopenia 2,500 mm3 , or anaemia emoglobine 6g/dl at basal Clinically significant uncontrolled bacterial, viral or fungal infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Relapse rate during the 24-weeks treatment with Neoral ciclosporine 5mg/kg/day twice a week;Secondary Objective: 1. time to relapse 2.change from baseline in PASI score 3.change from baseline in BSA score 4.change from baseline in VAS score for pruritus 5.Safety and tolerability;Primary end point(s): relapse rate
- Secondary Outcome Measures
Name Time Method