Psoriasis
Conditions
Keywords
psoriasis, randomized clinical trial, cyclosporine A, mycophenolate mofetil, immunosuppression
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.
Interventions
DRUGCyclosporine A versus mycophenolate mofetil for psoriasis
Sponsors
Hoffmann-La Roche
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the two treatment arms with regard to time until psoriasis recurrence. | — |
Secondary
| Measure | Time frame |
|---|---|
| The time until complete remission. | — |
| The time until partial remission has occured. | — |
| The treatment that leads to a 75% decrease of the initial PASI score. | — |
| The rate of partial remission. | — |
| The cumulative cyclosporine A or mycophenolate mofetil doses. | — |
| The rate of complete remission. | — |
Countries
Germany
Outcome results
None listed