CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.
This trial is active, not recruiting.
|Treatment||cyclosporine a versus mycophenolate mofetil for psoriasis|
|Sponsor||University Hospital Muenster|
|Start date||May 2000|
|End date||October 2006|
|Trial size||50 participants|
|Trial identifier||NCT00295425, 4016406, TALSB002|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Comparison of the two treatment arms with regard to time until psoriasis recurrence.
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.
Male or female participants from 18 years up to 75 years old.
- moderate-to-severe psoriasis (PASI Score equal and greated 10)
- written informed consent
- for female patients effective birth control
- psoriasis arthritis
- psoriasis palmo-plantaris
- erythrodermic psoriasis
- drug-induced psoriasis
- previous treatment with cyclosporine A or mycophenolate mofetil
- 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
|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.|
|Principal investigator||Stefan Beissert, Professor|
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