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CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by University Hospital Muenster.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00295425
First received: February 22, 2006
Last updated: October 4, 2006
Last verified: October 2006
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

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
Nicolas Hunzelmann
Cologne, Germany
Prof. Michael Sticherling
Leipzig, Germany
Sponsors and Collaborators
University Hospital Muenster
Hoffmann-La Roche
Investigators
Principal Investigator: Stefan Beissert, Professor Department of Dermatology, University Hospital Muenster, Muenster, Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00295425     History of Changes
Other Study ID Numbers: TALSB002, 4016406
Study First Received: February 22, 2006
Last Updated: October 4, 2006
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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013