Moderate to Severe Chronic Plaque PsoriasisPhase 4NCT00168753
Community Based Trial for AMEVIVE®
A Phase 4 study testing Alefacept in people with Moderate to Severe Chronic Plaque Psoriasis, run by Astellas Pharma Inc at 36 sites in United States.
Trial summary
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Chronic Plaque Psoriasis
- What is being tested?
- Alefacept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 36 sitesUnited States
- Study dates
- Jul 2004to Mar 2005
- 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
- Must give written informed consent.
- Must have had moderate, moderately severe or severe chronic plaque psoriasis as determined by the investigator prior to initial treatment (baseline) with AMEVIVE.
- Must be 18 years of age or older.
- Must have completed a standard 12-week course of AMEVIVE and have received at least 10 doses.
- Response to current AMEVIVE therapy must be less than a desired response as determined by the physician, and subject and some residual psoriasis must be present.
Who cannot join
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or not willing to practice effective contraception during the study.
- Nursing mothers, pregnant women, and women planning to become pregnant
- Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
- Treatment with another investigational drug, or approved therapy for investigational use, within 3 months of investigational drug administration.
- Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mycophenolate mofetil or other systemic immunosuppressant agents within 4 weeks of investigational drug administration.
- Treatment with Ultraviolet B (UVB) phototherapy or Psoralen + Ultraviolet A (PUVA), within 4 weeks of investigational drug administration.
Show all 16Show fewer
- Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
- History of >3 cutaneous squamous cell carcinomas or any systemic malignancy.
- Skin lesions suspicious for malignancy.
- Known HIV, viral hepatitis, or tuberculosis infection.
- History of severe allergic or anaphylactic reactions.
- ALT or AST greater than three times the upper limit of normal.
- Significantly abnormal hematology (hemoglobin, hematocrit, platelets, white blood cells), as determined by the investigator.
- CD4+ T lymphocyte count at screening visit less than 250 cells/mm3.
- Known hypersensitivity to AMEVIVE or any of its components.
- Subject's inability to comply with study requirements.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Pearlridge Dermatology
‘Aiea, Hawaii, 96701
Atlanta Derm, Vein & Research Center
Alpharetta, Georgia, 30004
Jayne Fortson
Anchorage, Alaska, 99501
Altman Dermatology Associates
Arlington Heights, Illinois, 60004
Bakersfield Dermatology & Skin Cancer Medical Group
Bakersfield, California, 93301
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Dermatology & Laser Center
Bellingham, Washington, 98225
Monheit Dermatology Associates
Birmingham, Alabama, 35203
Calumet Dermatology Associates
Calumet City, Illinois, 60477
Melissa Knuckles
Corbin, Kentucky, 40701
Texas Dermatology Research
Dallas, Texas, 75201
Front Dermatology
Denver, Colorado, 80014
Jerry Bagel
East Windsor, New Jersey, 08512
Michael Greenberg
Elk Grove Village, Illinois, 60007
Bayshore Dermatology
Fairhope, Alabama, 36532
Psoriasis Treatment Center
Grand Rapids, Michigan, 49503
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37902
Woodson Clinical Studies Group, Inc.
Las Vegas, Nevada, 89101
Mark Wallis
Longview, Texas, 75601
Catskill Dermatology
Monticello, New York, 12701
Nashua Dermatology
Nashua, New Hampshire, 03060
Gold Skin Care
Nashville, Tennessee, 37201
David J. Coynik
Peru, Illinois, 61354
Richard Eisen
Plymouth, Massachusetts, 02360
Dermatology Assoc of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
Integrated Research Group
Riverside, California, 92501
Dermatology & Laser Center of Roseberg
Roseburg, Oregon, 97470
Stephen Miller
San Antonio, Texas, 78201
Robert Greenberg
San Ramon, California, 94582
Marina I Peredo
Smithtown, New York, 11787
Skin and Cancer Associates
Tamarac, Florida, 33309
Michael Scannon
Tampa, Florida, 33602
Robert Brodell
Warren, Ohio, 44481
Buffalo Medical Group
Williamsville, New York, 14221
Wilmington Health Associates Dermatology
Wilmington, North Carolina, 28401
Stephen Flax
Winchester, Virginia, 22601
About this study
Official title: An Open-Label Community-Based Study to Determine the Safety and Efficacy of an Extended Course of Alefacept, Following a Standard 12-Week Course of Amevive®, With Commonly Used Clinical Assessment Tools
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.
Read the detailed description
Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response.
Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.
- Being tested
- Alefacept
- Keywords
- Extended dosing, alefacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlefaceptDrug
Also called Amevive, ASP0485
IM
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Alefacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE.
Measured: 16 weeks, 20 weeks or 24 weeks
Secondary outcomes (7)
The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,
Measured: End of study
The cumulative change in PQA score from screening visit to best PQA score at any time in the study,
Measured: End of study
Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study,
Measured: End of study
Time to re-treatment for subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,
Measured: End of study
The cumulative change in SSA score from screening visit to best SSA score at any time in the study,
Measured: End of study
Association of the total number of doses received with the best efficacy reached, as assessed by SSA score, at any time during the study, and
Measured: End of study
Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Michael Gold, Principal investigator, GoldSkin Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168753
- Sponsor's protocol ID
- IST-US-064-04-AME
- Other IDs
- CBT/IST 64
- Status last verified
- Sep 2014
- First submitted
- 13 Sep 2005
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Community-Based Study to Determine the Safety and Efficacy of an Extended Course of Alefacept, Following a Standard 12-Week Course of Amevive®, With Commonly Used Clinical Assessment Tools
- ClinicalTrials.gov ID
- NCT00168753
- Acronym / sponsor ID
- IST-US-064-04-AME
- Keywords
- Extended dosing, alefacept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Jul 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 15 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.
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.
Detailed description
Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response.
Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Alefacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must give written informed consent.
- Must have had moderate, moderately severe or severe chronic plaque psoriasis as determined by the investigator prior to initial treatment (baseline) with AMEVIVE.
- Must be 18 years of age or older.
- Must have completed a standard 12-week course of AMEVIVE and have received at least 10 doses.
- Response to current AMEVIVE therapy must be less than a desired response as determined by the physician, and subject and some residual psoriasis must be present.
Key exclusion criteria (16 listed)
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or not willing to practice effective contraception during the study.
- Nursing mothers, pregnant women, and women planning to become pregnant
- Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
- Treatment with another investigational drug, or approved therapy for investigational use, within 3 months of investigational drug administration.
- Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mycophenolate mofetil or other systemic immunosuppressant agents within 4 weeks of investigational drug administration.
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, ASP0485IM | Drug | 1 |
Primary outcome
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE.
Time frame: 16 weeks, 20 weeks or 24 weeks
7 secondary outcomes
The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,
Time frame: End of study
The cumulative change in PQA score from screening visit to best PQA score at any time in the study,
Time frame: End of study
Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study,
Time frame: End of study
Time to re-treatment for subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,
Time frame: End of study
The cumulative change in SSA score from screening visit to best SSA score at any time in the study,
Time frame: End of study
Association of the total number of doses received with the best efficacy reached, as assessed by SSA score, at any time during the study, and
Time frame: End of study
Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively.
Time frame: End of study
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 8 Sep 2014.
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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.
Michael Gold principal investigator
GoldSkin Care
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alefacept in people with Moderate to Severe Chronic Plaque Psoriasis, run by Astellas Pharma Inc at 36 sites 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 5 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: finished, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites 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 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?
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE. (time frame: 16 weeks, 20 weeks or 24 weeks). 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 8 Sep 2014.