CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

Psoriasis Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00295425
• Other study ID #: TALSB002
• Secondary ID: 4016406
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 22, 2006
• Last updated: October 4, 2006
• Start date: May 2000
• Est. completion date: October 2006

Study information

• Verified date: October 2006
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

Not needed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Cyclosporine A versus mycophenolate mofetil for psoriasis

Locations

Country	Name	City	State
Germany	Nicolas Hunzelmann	Cologne
Germany	Prof. Michael Sticherling	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the two treatment arms with regard to time until psoriasis recurrence.
Secondary	The treatment that leads to a 75% decrease of the initial PASI score.
Secondary	The time until complete remission.
Secondary	The time until partial remission has occured.
Secondary	The rate of complete remission.
Secondary	The rate of partial remission.
Secondary	The cumulative cyclosporine A or mycophenolate mofetil doses.