CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by University Hospital Muenster.
Recruitment status was Active, not recruiting
Information provided by:
University Hospital Muenster
First received: February 22, 2006
Last updated: October 4, 2006
Last verified: October 2006
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.
Drug: Cyclosporine A versus mycophenolate mofetil for psoriasis
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Open, Multicenter, Randomized Clinical Trial in Patients With Moderate-Severe Psoriasis (PASI > 10) to Compare the Efficacy of Mycophenolate Mofetil Versus Cyclosporine A.
Primary Outcome Measures:
- Comparison of the two treatment arms with regard to time until psoriasis recurrence.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295425
|Cologne, Germany |
|Prof. Michael Sticherling
|Leipzig, Germany |
University Hospital Muenster
||Stefan Beissert, Professor
||Department of Dermatology, University Hospital Muenster, Muenster, Germany
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 22, 2006
||October 4, 2006
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by University Hospital Muenster:
randomized clinical trial
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014
Skin Diseases, Papulosquamous
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs