ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis

This study is currently recruiting participants.
Verified by Novartis, August 2008

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00438360
  Purpose

The study will evaluate the efficacy of cyclosporine 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
Phase III

MedlinePlus related topics:   Psoriasis   

ChemIDplus related topics:   Cyclosporine    Cyclosporin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Relapse rate, as assessed by PASI (Psoriasis Area and Severity Index )score

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   264
Study Start Date:   May 2006

  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

Contacts
Contact: novartis     41613241111    

Locations
Italy
Novartis Investigative Site     Recruiting
      Bari, Italy
      Contact: novartis     41613241111        

Sponsors and Collaborators
Novartis

Investigators
Study Director:     Novartis     Novartis    
  More Information


Responsible Party:   Novartis ( Novartis )
Study ID Numbers:   COLO400CIT04
First Received:   February 21, 2007
Last Updated:   August 13, 2008
ClinicalTrials.gov Identifier:   NCT00438360
Health Authority:   Italy: The Italian Medicines Agency

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

Study placed in the following topic categories:
Cyclosporine
Skin Diseases
Clotrimazole
Psoriasis
Miconazole
Tioconazole
Cyclosporins
Skin Diseases, Papulosquamous

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

ClinicalTrials.gov processed this record on October 17, 2008




Links to all studies - primarily for crawlers