Open, Multicenter, Randomized Clinical Trial in Patients With Moderate-Severe Psoriasis (PASI > 10) to Compare the Efficacy of Mycophenolate Mofetil Versus Cyclosporine A.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- University Hospital Muenster
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Comparison of the two treatment arms with regard to time until psoriasis recurrence.
- Last Updated
- 19 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Comparison of the two treatment arms with regard to time until psoriasis recurrence.
Secondary Outcomes
- 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.