PsoriasisPhase 2NCT00143806
Transitioning From Cyclosporine to Alefacept in Psoriasis
A Phase 2 study testing Transitioning patients from cyclosporine to alefacept in people with Psoriasis, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Transitioning patients from cyclosporine to alefacept
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to May 2007
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult psoriasis patients (18 to 80 years old), who are well controlled on cyclosporine (Static PGA score of mild, minimal or clear) and who need or desire to stop cyclosporine and start alefacept.
Who cannot join
- CD4 <400
- Active infection (other than trivial URI, etc.)
- History of AIDS or Hepatitis B, C
- Inability to understand consent or comply with study requirements
- Pregnancy or Lactation
- History of heart or liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
UMDNJ Clinical Research Center
New Brunswick, New Jersey, 08903
About this study
Official title: Investigator-Initiated, Use Study of Alefacept (Amevive) in Combination With Tapering Doses of Cyclosporine in Patients With Moderate to Severe Psoriasis
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.
Read the detailed description
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept. Patients in the study are well controlled on cyclosporine and desire to switch to alefacept. The study is done in three phases. In Phase 1 (12 week duration) the two drugs will be overlapped, with cyclosporine slowly tapering. Both drugs will be discontinued after 12 weeks. In Phase 2 (12 weeks duration), patients are off both drugs. In Phase 3 (24 weeks long), patients are on a second course of alefacept alone for 12 weeks and then off for 12 weeks. Topical and UV light treatments are allowed throughout the study. Total length of study is one year.
- Conditions
- Psoriasis
- Being tested
- Transitioning patients from cyclosporine to alefacept
- Keywords
- psoriasis, cyclosporine, transition, alefacept
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitioning patients from cyclosporine to alefaceptDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Static physicians global assessment (PGA) and quality of life as measured by DLQI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startOct 2003
- Study completionMay 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Investigators
- Alice Gottlieb, MD, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143806
- Sponsor's protocol ID
- 4513
- Status last verified
- Dec 2008
- First submitted
- 31 Aug 2005
- Last updated
- 5 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-Initiated, Use Study of Alefacept (Amevive) in Combination With Tapering Doses of Cyclosporine in Patients With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT00143806
- Acronym / sponsor ID
- 4513
- Conditions
- Psoriasis
- Keywords
- psoriasis, cyclosporine, transition, alefacept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Oct 2003
- Study completion
- May 2007
- First posted
- 2 Sep 2005 (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.
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.
Detailed description
The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept. Patients in the study are well controlled on cyclosporine and desire to switch to alefacept. The study is done in three phases. In Phase 1 (12 week duration) the two drugs will be overlapped, with cyclosporine slowly tapering. Both drugs will be discontinued after 12 weeks. In Phase 2 (12 weeks duration), patients are off both drugs. In Phase 3 (24 weeks long), patients are on a second course of alefacept alone for 12 weeks and then off for 12 weeks. Topical and UV light treatments are allowed throughout the study. Total length of study is one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult psoriasis patients (18 to 80 years old), who are well controlled on cyclosporine (Static PGA score of mild, minimal or clear) and who need or desire to stop cyclosporine and start alefacept.
Key exclusion criteria (6 listed)
- CD4 <400
- Active infection (other than trivial URI, etc.)
- History of AIDS or Hepatitis B, C
- Inability to understand consent or comply with study requirements
- Pregnancy or Lactation
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 |
|---|---|---|
| Transitioning patients from cyclosporine to alefacept | Drug | – |
Primary outcome
Static physicians global assessment (PGA) and quality of life as measured by DLQI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
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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.
Alice Gottlieb, MD, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transitioning patients from cyclosporine to alefacept in people with Psoriasis, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Static physicians global assessment (PGA) and quality of life as measured by DLQI. 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 Jan 2009.