CYA Versus MMF for Treatment of Moderate-Severe Psoriasis. - Full Text View

Purpose

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

U.S. FDA Resources

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.

Further study details as provided by University Hospital Muenster:

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:	50
Study Start Date:	May 2000
Estimated Study Completion Date:	October 2006

Detailed Description:

Not needed.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295425

Locations


Germany
	Prof. Michael Sticherling
	Leipzig, Germany
	Nicolas Hunzelmann
	Cologne, Germany

Sponsors and Collaborators

University Hospital Muenster

Hoffmann-La Roche

Investigators


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

More Information

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

Keywords provided by University Hospital Muenster:

psoriasis

randomized clinical trial

cyclosporine A

mycophenolate mofetil

immunosuppression

Study placed in the following topic categories:

Cyclosporine

Skin Diseases

Clotrimazole

Psoriasis

Miconazole

Tioconazole

Mycophenolic Acid

Mycophenolate mofetil

Cyclosporins

Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Infective Agents

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antibiotics, Antineoplastic

Immunosuppressive Agents

Pharmacologic Actions

Antifungal Agents

Therapeutic Uses

Antirheumatic Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 29, 2008

Sponsors and Collaborators:	University Hospital Muenster Hoffmann-La Roche
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00295425