CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295425
Recruitment Status : Unknown
Verified October 2006 by University Hospital Muenster.
Recruitment status was:  Active, not recruiting
First Posted : February 23, 2006
Last Update Posted : October 5, 2006
Hoffmann-La Roche
Information provided by:
University Hospital Muenster

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Cyclosporine A versus mycophenolate mofetil for psoriasis Phase 2

Detailed Description:
Not needed.

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : May 2000
Study Completion Date : October 2006

Primary Outcome Measures :
  1. Comparison of the two treatment arms with regard to time until psoriasis recurrence.

Secondary Outcome Measures :
  1. The treatment that leads to a 75% decrease of the initial PASI score.
  2. The time until complete remission.
  3. The time until partial remission has occured.
  4. The rate of complete remission.
  5. The rate of partial remission.
  6. The cumulative cyclosporine A or mycophenolate mofetil doses.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295425

Nicolas Hunzelmann
Cologne, Germany
Prof. Michael Sticherling
Leipzig, Germany
Sponsors and Collaborators
University Hospital Muenster
Hoffmann-La Roche
Principal Investigator: Stefan Beissert, Professor Department of Dermatology, University Hospital Muenster, Muenster, Germany Identifier: NCT00295425     History of Changes
Other Study ID Numbers: TALSB002
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: October 5, 2006
Last Verified: October 2006

Keywords provided by University Hospital Muenster:
randomized clinical trial
cyclosporine A
mycophenolate mofetil

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents