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Clinical Trial Name - Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Ps
| Original Study ID : COLO400CIT04 |
| NCT ID : NCT00438360 |
| Brief Title : Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis |
| Official Title : A 24-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study, to Evaluate the Effectiveness of Cyclosporine 2,5 mg/kg/Day Bid Twice a Week on Reducing Relapse Rate, in Maintenance Patients With Chronic Plaque Psoriasis |
| Brief Summary : The study will evaluate the efficacy of cyclosporine when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis. |
| Source : Novartis |
| Overall Status : Recruiting |
| Start Date : May 2006 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 264 |
| Verification Date : February 2009 |
| First Received Date : February 21, 2007 |
| Trial Eligibility |
| Criteria : Inclusion criteria: - Outpatients 18 years of age and older (max 65 years) - Patients with chronic plaque psoriasis on disease remission (i.e. PASI ≤75% of PASI before cyclosporine continuous treatment course) entering a maintenance period - Disease remission obtained with only cyclosporine as systemic therapy (maximum dose 5 mg/kg/day) for >8 weeks and <16 weeks - PASI still <75% of PASI before cyclosporine continuous treatment course, at randomization to study treatment (8±2 days after disease remission) Exclusion criteria: - Abnormal renal function (creatinine ≥ 10% the upper limit of the reference range) - Severe chronic degenerative diseases - Severe uncontrolled hypertension - Body weigh >110 kg - Abnormal liver function - Hyperkalemia or hyperuricemia - Clinically significant impairment of hematopoietic and cardiovascular function - Concomitant therapy with nephrotoxic medications - Patients with malignancy or a history of malignancy - Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception - Clinically significant uncontrolled bacterial, viral or fungal infection - Evidence of drug and/or alcohol abuse |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : 65 Years |
| Facilities |
| Facility Name : Novartis Investigative Site |
| Status : Recruiting |
| City : Bari |
| Country : Italy |
| OutComes |
| Primary OutComes |
| Measure : Relapse rate, as assessed by PASI (Psoriasis Area and Severity Index )score |
| Secondary OutComes |
| Measure : Time to relapse |
| Measure : Change from baseline in PASI score at every visit and on relapse |
| Measure : Change from baseline in BSA (Body Surface Area) score at every visit and on relapse |
| Measure : Change from baseline in VAS (Visual Analogue Scale) for Patient Self assessment of pruritus at every visit and on relapse |
| Measure : Safety / Tolerability assessed by adverse events |
| Interventions |
| Type : Drug |
| Name : Cyclosporine A microemulsion |
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