Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis

Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438360
• Other study ID #: COLO400CIT04
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2007
• Last updated: July 13, 2011
• Start date: May 2006
• Est. completion date: November 2007

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Cyclosporine A microemulsion
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
• Placebo
Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations

Locations

Country	Name	City	State
Italy	Novartis Investigative Site	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 weeks	No
Secondary	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.	24 weeks	No
Secondary	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.	baseline and week 24	No
Secondary	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	Baseline and week 24	No
Secondary	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).	Baseline and week 24	No
Secondary	Safety / Tolerability Assessed by Adverse Events		24weeks	Yes