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

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Cyclosporine A microemulsion
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Cyclosporine, chronic plaque psoriasis, intermittent therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cyclosporine A

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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
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).
Safety / Tolerability Assessed by Adverse Events

Full Information

First Posted
February 21, 2007
Last Updated
July 13, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
Cyclosporine, chronic plaque psoriasis, intermittent therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclosporine A
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
Intervention Type
Drug
Intervention Name(s)
Cyclosporine A microemulsion
Other Intervention Name(s)
Neoral
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
Primary Outcome Measure Information:
Title
Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score
Description
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
Secondary Outcome Measure Information:
Title
Proportion of Participants With Clinical Relapse
Description
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
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Description
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
Title
Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis
Description
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
Title
Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus
Description
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
Title
Safety / Tolerability Assessed by Adverse Events
Time Frame
24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bari
Country
Italy

12. IPD Sharing Statement

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

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