CYA Versus MMF for Treatment of Moderate-Severe Psoriasis. | NCT00295425

Studies
CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

NCT00295425

Sponsor

University Hospital Muenster

Status

Unknown status

Last Update Posted

Oct 5, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Psoriasis

Interventions

Cyclosporine A versus mycophenolate mofetil for psoriasis

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
4016406

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2000

Primary Completion Date

Not provided

Completion Date

Oct 2006

First Submitted Date

Feb 22, 2006

First Submission Date that Met QC Criteria

Feb 22, 2006

First Posted Date

Feb 23, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2006

Last Update Posted Date

Oct 5, 2006Estimated

Name	Class
Hoffmann-La Roche	INDUSTRY

Description Module

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.

Detailed Description

Not needed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Cyclosporine A versus mycophenolate mofetil for psoriasis	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of the two treatment arms with regard to time until psoriasis recurrence.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Beissert, Professor	Department of Dermatology, University Hospital Muenster, Muenster, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nicolas Hunzelmann		Cologne			Germany
Prof. Michael Sticherling

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided