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

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ClinicalTrials.gov Identifier: NCT00438360
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : August 9, 2011
Last Update Posted : August 9, 2011
Sponsor:
Information provided by:
Novartis

February 21, 2007
February 22, 2007
December 15, 2010
August 9, 2011
August 9, 2011
May 2006
November 2007   (Final data collection date for primary outcome measure)
Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score [ Time Frame: 24 weeks ]
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).
Relapse rate, as assessed by PASI (Psoriasis Area and Severity Index )score
Complete list of historical versions of study NCT00438360 on ClinicalTrials.gov Archive Site
  • Proportion of Participants With Clinical Relapse [ Time Frame: 24 weeks ]
    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 [ Time Frame: baseline and week 24 ]
    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 [ Time Frame: Baseline and week 24 ]
    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 [ Time Frame: Baseline and week 24 ]
    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 [ Time Frame: 24weeks ]
  • Time to relapse
  • Change from baseline in PASI score at every visit and on relapse
  • Change from baseline in BSA (Body Surface Area) score at every visit and on relapse
  • Change from baseline in VAS (Visual Analogue Scale) for Patient Self assessment of pruritus at every visit and on relapse
  • Safety / Tolerability Assessed by Adverse Events
Not Provided
Not Provided
 
Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Plaque Psoriasis
  • 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
    Other Name: Neoral
  • Drug: Placebo
    Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
  • Active Comparator: Cyclosporine A
    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: Drug: Cyclosporine A microemulsion
  • Placebo Comparator: Placebo
    Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
264
November 2007
November 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00438360
COLO400CIT04
Not Provided
Not Provided
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP