Back to resultsCYA Versus MMF for Treatment of Moderate-Severe Psoriasis.
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cyclosporine A versus mycophenolate mofetil for psoriasis
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, randomized clinical trial, cyclosporine A, mycophenolate mofetil, immunosuppression
Eligibility Criteria
Inclusion Criteria: moderate-to-severe psoriasis (PASI Score equal and greated 10) written informed consent for female patients effective birth control Exclusion Criteria: psoriasis arthritis psoriasis palmo-plantaris erythrodermic psoriasis drug-induced psoriasis pregnancy previous treatment with cyclosporine A or mycophenolate mofetil pregnancy reduced liver function high blood pressure reduced kidney function severe viral or bacterial infection 2 weeks before or after vaccinations innate or acquired immunodeficiency severe neurologic or psychiatric symptoms participation in other trials other reasons voiced by the treating physician
Sites / Locations
- Nicolas Hunzelmann
- Prof. Michael Sticherling
Outcomes
Primary Outcome Measures
Comparison of the two treatment arms with regard to time until psoriasis recurrence.
Secondary Outcome Measures
The treatment that leads to a 75% decrease of the initial PASI score.
The time until complete remission.
The time until partial remission has occured.
The rate of complete remission.
The rate of partial remission.
The cumulative cyclosporine A or mycophenolate mofetil doses.
Full Information
NCT ID
NCT00295425
First Posted
February 22, 2006
Last Updated
October 4, 2006
Sponsor
University Hospital Muenster
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00295425
Brief Title
CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.
Official Title
Open, Multicenter, Randomized Clinical Trial in Patients With Moderate-Severe Psoriasis (PASI > 10) to Compare the Efficacy of Mycophenolate Mofetil Versus Cyclosporine A.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Muenster
Collaborators
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
Psoriasis is an immuno-mediated skin disorder, which affects about 2-3% of the population worldwide. For moderate-severe forms of psoriasis systemic immunosuppression is the treatment of choice. This clinical trial was initiated to compare the safety and effectiveness of mycophenolate mofetil and cyclosporine A for the treatment of psoriasis. Patients are randomized to receive either 2.5 mg/kg BW cyclosporine A or 1 g bid mycophenolate mofetil. If after six weeks no decrease in the PASI score occures cyclosporine A doses are increased to 5 mg/kg BW for additional six weeks. In the other arm mycophenolate mofetil is increased to 1 g tid for additional six weeks.
Detailed Description
Not needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, randomized clinical trial, cyclosporine A, mycophenolate mofetil, immunosuppression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cyclosporine A versus mycophenolate mofetil for psoriasis
Primary Outcome Measure Information:
Title
Comparison of the two treatment arms with regard to time until psoriasis recurrence.
Secondary Outcome Measure Information:
Title
The treatment that leads to a 75% decrease of the initial PASI score.
Title
The time until complete remission.
Title
The time until partial remission has occured.
Title
The rate of complete remission.
Title
The rate of partial remission.
Title
The cumulative cyclosporine A or mycophenolate mofetil doses.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
moderate-to-severe psoriasis (PASI Score equal and greated 10)
written informed consent
for female patients effective birth control
Exclusion Criteria:
psoriasis arthritis
psoriasis palmo-plantaris
erythrodermic psoriasis
drug-induced psoriasis
pregnancy
previous treatment with cyclosporine A or mycophenolate mofetil
pregnancy
reduced liver function
high blood pressure
reduced kidney function
severe viral or bacterial infection
2 weeks before or after vaccinations
innate or acquired immunodeficiency
severe neurologic or psychiatric symptoms
participation in other trials
other reasons voiced by the treating physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Beissert, Professor
Organizational Affiliation
Department of Dermatology, University Hospital Muenster, Muenster, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nicolas Hunzelmann
City
Cologne
Country
Germany
Facility Name
Prof. Michael Sticherling
City
Leipzig
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.
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