Overview

This trial is active, not recruiting.

Condition psoriasis
Treatment cyclosporine a versus mycophenolate mofetil for psoriasis
Phase phase 2
Sponsor University Hospital Muenster
Collaborator Hoffmann-La Roche
Start date May 2000
End date October 2006
Trial size 50 participants
Trial identifier NCT00295425, 4016406, TALSB002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Comparison of the two treatment arms with regard to time until psoriasis recurrence.
time frame:

Secondary Outcomes

Measure
The treatment that leads to a 75% decrease of the initial PASI score.
time frame:
The time until complete remission.
time frame:
The time until partial remission has occured.
time frame:
The rate of complete remission.
time frame:
The rate of partial remission.
time frame:
The cumulative cyclosporine A or mycophenolate mofetil doses.
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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.
Principal investigator Stefan Beissert, Professor
Description Not needed.
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by University Hospital Muenster.