PsoriasisPhase 2NCT00295425
CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.
A Phase 2 study testing Cyclosporine A versus mycophenolate mofetil for psoriasis in people with Psoriasis, run by University Hospital Muenster at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Cyclosporine A versus mycophenolate mofetil for psoriasis
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- May 2000to Oct 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate-to-severe psoriasis (PASI Score equal and greated 10)
- written informed consent
- for female patients effective birth control
Who cannot join
- psoriasis arthritis
- psoriasis palmo-plantaris
- erythrodermic psoriasis
- drug-induced psoriasis
- pregnancy
- previous treatment with cyclosporine A or mycophenolate mofetil
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this 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.
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.
Read the detailed description
Not needed.
- Conditions
- Psoriasis
- Being tested
- Cyclosporine A versus mycophenolate mofetil for psoriasis
- Keywords
- psoriasis, randomized clinical trial, cyclosporine A, mycophenolate mofetil, immunosuppression
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine A versus mycophenolate mofetil for psoriasisDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the two treatment arms with regard to time until psoriasis recurrence.
Secondary outcomes (6)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startMay 2000
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Stefan Beissert, Professor, Principal investigator, Department of Dermatology, University Hospital Muenster, Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295425
- Sponsor's protocol ID
- TALSB002
- Other IDs
- 4016406
- Status last verified
- Oct 2006
- First submitted
- 22 Feb 2006
- Last updated
- 5 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00295425
- Acronym / sponsor ID
- TALSB002
- Conditions
- Psoriasis
- Keywords
- psoriasis, randomized clinical trial, cyclosporine A, mycophenolate mofetil, immunosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- May 2000
- Study completion
- Oct 2006
- First posted
- 23 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- moderate-to-severe psoriasis (PASI Score equal and greated 10)
- written informed consent
- for female patients effective birth control
Key exclusion criteria (16 listed)
- psoriasis arthritis
- psoriasis palmo-plantaris
- erythrodermic psoriasis
- drug-induced psoriasis
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine A versus mycophenolate mofetil for psoriasis | Drug | – |
Primary outcome
Comparison of the two treatment arms with regard to time until psoriasis recurrence.
6 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Beissert, Professor principal investigator
Department of Dermatology, University Hospital Muenster, Muenster, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclosporine A versus mycophenolate mofetil for psoriasis in people with Psoriasis, run by University Hospital Muenster at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the two treatment arms with regard to time until psoriasis recurrence.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2006.