CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

Study Overview
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Brief Summary
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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
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Not needed.

Official Title
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Open, Multicenter, Randomized Clinical Trial in Patients With Moderate-Severe Psoriasis (PASI > 10) to Compare the Efficacy of Mycophenolate Mofetil Versus Cyclosporine A.

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Cyclosporine A versus mycophenolate mofetil for psoriasis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclosporine A versus mycophenolate mofetil for psoriasis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the two treatment arms with regard to time until psoriasis recurrence. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, randomized clinical trial, cyclosporine A, mycophenolate mofetil, immunosuppression