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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 02, 2014