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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00438360
First received: February 21, 2007
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: Cyclosporine A microemulsion
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Enrollment: 243
Study Start Date: May 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: Placebo
Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
Drug: Placebo
Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438360

Locations
Italy
Novartis Investigative Site
Bari, Italy
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00438360     History of Changes
Other Study ID Numbers: COLO400CIT04
Study First Received: February 21, 2007
Results First Received: December 15, 2010
Last Updated: July 13, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Novartis:
Cyclosporine, chronic plaque psoriasis, intermittent therapy

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 15, 2014