CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.
Open, Multicenter, Randomized Clinical Trial in Patients With Moderate-Severe Psoriasis (PASI > 10) to Compare the Efficacy of Mycophenolate Mofetil Versus Cyclosporine A.
2 other identifiers
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2000
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 22, 2006
CompletedFirst Posted
Study publicly available on registry
February 23, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedOctober 5, 2006
October 1, 2006
February 22, 2006
October 4, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of the two treatment arms with regard to time until psoriasis recurrence.
Secondary Outcomes (6)
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.
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- moderate-to-severe psoriasis (PASI Score equal and greated 10)
- written informed consent
- for female patients effective birth control
You may not qualify if:
- 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
- weeks before or after vaccinations
- innate or acquired immunodeficiency
- severe neurologic or psychiatric symptoms
- participation in other trials
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Muensterlead
- Hoffmann-La Rochecollaborator
Study Sites (2)
Nicolas Hunzelmann
Cologne, Germany
Prof. Michael Sticherling
Leipzig, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Beissert, Professor
Department of Dermatology, University Hospital Muenster, Muenster, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 22, 2006
First Posted
February 23, 2006
Study Start
May 1, 2000
Study Completion
October 1, 2006
Last Updated
October 5, 2006
Record last verified: 2006-10