The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
243
Oral soft gelatin capsules of Cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations
Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
Novartis Investigative Site
Bari, Italy
Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score
PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score \>75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was \>= 75%. In all the other cases the patient was considered as success (no relapse).
Time frame: 24 weeks
Proportion of Participants With Clinical Relapse
Clinical relapse was defined as worsening of psoriasis associated with a Psoriasis Area and Severity Index (PASI) \>75% of the PASI score assessed before the continuous treatment, or when the investigator or the patient judged it necessary to change the treatment.
Time frame: 24 weeks
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree.
Time frame: baseline and week 24
Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis
BSA is a measure of the percentage of body surface affected by psoriasis. Using the Mosteller Formula: BSA = BSA (m²) = ( \[Height(in) x Weight(lbs) \]/ 3131 )½ . A covariance analysis was performed on all variables, with value assessed at visit 2 as covariate and center as effect. For each variable the changes versus the last available measures were computed
Time frame: Baseline and week 24
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Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus
Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 24 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).
Time frame: Baseline and week 24
Safety / Tolerability Assessed by Adverse Events
Time frame: 24weeks