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Sponsors and Collaborators: |
University Hospital Muenster Hoffmann-La Roche |
Information provided by: | University Hospital Muenster |
ClinicalTrials.gov Identifier: | NCT00295425 |
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.
Condition | Intervention | Phase |
Psoriasis |
Drug: Cyclosporine A versus mycophenolate mofetil for psoriasis |
Phase II |
MedlinePlus related topics: | Psoriasis |
Drug Information available for: | Cyclosporine Cyclosporin Mycophenolate Mofetil Mycophenolate mofetil hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 50 |
Study Start Date: | May 2000 |
Estimated Study Completion Date: | October 2006 |
Not needed.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
Prof. Michael Sticherling | |||||
Leipzig, Germany | |||||
Nicolas Hunzelmann | |||||
Cologne, Germany |
University Hospital Muenster |
Hoffmann-La Roche |
Principal Investigator: | Stefan Beissert, Professor | Department of Dermatology, University Hospital Muenster, Muenster, Germany |
Principal Investigator: | Stefan Beissert, Professor | Department of Dermatology, University Hospital Muenster, Muenster, Germany |
Study ID Numbers: | TALSB002, 4016406 |
First Received: | February 22, 2006 |
Last Updated: | October 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00295425 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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