Chronic Plaque PsoriasisPhase 4NCT00493324
Study to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque Psoriasis
A Phase 4 study testing alefacept and polyvalent pneumococcal vaccine in people with Chronic Plaque Psoriasis, run by Astellas Pharma Inc at 7 sites in 2 countries.
Trial summary
A vaccine causes the immune system to produce antibodies (immune response) to specific germs to protect the patient. This study evaluates the immune response to the pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- alefacept and polyvalent pneumococcal vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jul 2007to Jul 2008
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has chronic plaque psoriasis
- Subject has at least 5% body surface area affected with psoriasis
Who cannot join
- Skin disorder other than plaque psoriasis in affected area
- Previously immunized with any pneumococcal vaccine
- Subject has pustular or erythrodermic psoriasis
- Subject is immunocompromised
- Six or more herpes simplex virus outbreaks per year
- History or malignancy, chronic serious infection or hepatic disease
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Study site
Birmingham, Alabama, 35205
Study site
Cleveland, Ohio, 44106
Study site
New York, New York, 10016
Study site
New York, New York, 10029
Study site
San Diego, California, 92123
Canada2 sites
Study site
Markham, Ontario, L3P 1A8
Study site
St. John's, Newfoundland and Labrador, A1B 3E1
About this study
Official title: An Open-Label Phase 4 Study in Adult Patients With Chronic Plaque Psoriasis to Evaluate the Immune Response to Pneumococcal Vaccine in Subjects Treated With Alefacept
A vaccine causes the immune system to produce antibodies (immune response) to specific germs to protect the patient. This study evaluates the immune response to the pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.
Read the detailed description
This is a 1 arm study designed to evaluate the immune response to pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- alefacept, polyvalent pneumococcal vaccine
- Keywords
- psoriasis, alefacept, polyvalent pneumococcal vaccine, Immunization
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alefaceptDrug
Also called Amevive®, ASP0485
Intramuscular
polyvalent pneumococcal vaccineDrug
Also called PNEUMOVAX® 23
Injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: alefacept; Drug: polyvalent pneumococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and percentage of subjects with at least a 2-fold increase in 2 or more of 5 pneumococcal antibody titers.
Measured: 12 weeks
Secondary outcomes (1)
The number and percentage of subjects with an antibody response to pneumococcal antigens
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Plaque 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493324
- Sponsor's protocol ID
- 0485-CL-0003
- Status last verified
- Jan 2012
- First submitted
- 27 Jun 2007
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lynde C, Krell J, Korman N, Mathes B; Vaccine Study Investigators. Immune response to pneumococcal polysaccharide vaccine in adults with chronic plaque psoriasis treated with alefacept. J Am Acad Dermatol. 2011 Oct;65(4):799-806. doi: 10.1016/j.jaad.2010.04.040. Epub 2011 Mar 30.
PubMed 21453987
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 4 Study in Adult Patients With Chronic Plaque Psoriasis to Evaluate the Immune Response to Pneumococcal Vaccine in Subjects Treated With Alefacept
- ClinicalTrials.gov ID
- NCT00493324
- Acronym / sponsor ID
- 0485-CL-0003
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- psoriasis, alefacept, polyvalent pneumococcal vaccine, Immunization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 Jun 2007 (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.
A vaccine causes the immune system to produce antibodies (immune response) to specific germs to protect the patient. This study evaluates the immune response to the pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.
Detailed description
This is a 1 arm study designed to evaluate the immune response to pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: alefacept, Drug: polyvalent pneumococcal vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has chronic plaque psoriasis
- Subject has at least 5% body surface area affected with psoriasis
Key exclusion criteria (6 listed)
- Skin disorder other than plaque psoriasis in affected area
- Previously immunized with any pneumococcal vaccine
- Subject has pustular or erythrodermic psoriasis
- Subject is immunocompromised
- Six or more herpes simplex virus outbreaks per year
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 |
|---|---|---|
| alefaceptAlso: Amevive®, ASP0485Intramuscular | Drug | 1 |
| polyvalent pneumococcal vaccineAlso: PNEUMOVAX® 23Injection | Drug | 1 |
Primary outcome
The number and percentage of subjects with at least a 2-fold increase in 2 or more of 5 pneumococcal antibody titers.
Time frame: 12 weeks
1 secondary outcome
The number and percentage of subjects with an antibody response to pneumococcal antigens
Time frame: 12 weeks
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 2 Feb 2012.
- Background: PubMed 21453987Lynde C, Krell J, Korman N, Mathes B; Vaccine Study Investigators. Immune response to pneumococcal polysaccharide vaccine in adults with chronic plaque psoriasis treated with alefacept. J Am Acad Dermatol. 2011 Oct;65(4):799-806. doi: 10.1016/j.jaad.2010.04.040. Epub 2011 Mar 30.
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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.
Use Central Contact study director
Astellas Pharma US, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing alefacept and polyvalent pneumococcal vaccine in people with Chronic Plaque Psoriasis, run by Astellas Pharma Inc at 7 sites in 2 countries.
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 2 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The number and percentage of subjects with at least a 2-fold increase in 2 or more of 5 pneumococcal antibody titers. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00493324, which also lists 1 linked publication.
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 2 Feb 2012.