Chronic Plaque PsoriasisNCT00422617
Evaluate the Efficacy and Safety of One Course of Amevive in Taiwan Patients
A study testing Alefacept (Amevive) in people with Chronic Plaque Psoriasis, run by Uni-Pharma.
Trial summary
An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- Alefacept (Amevive)
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Nov 2005
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must give written informed consent
- Must be >= 16 years of age
- Must have been diagnosed with chronic plaque psoriasis at least one year and require systemic or phototherapy
- Must have CD4+ lymphocyte count at or above the lower limit of normal
- Must have a BSA >= 10%
Who cannot join
- Current erythrodermic, generalized pustular, or guttate psoriasis
- Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
- History of any clinical significant disease that would be contraindicated for this study as determined by the investigator
- Prior history of systemic malignancy, untreated localised skin canceer or a >10 squamous cell carcinoma
- Current enrollment in any other investigational drug study within 30 days prior to study drug administration
- Treatment with systemic immunosuppressant agents within the 4 weeks prior to study drug administration.
About this study
An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis
Read the detailed description
The purpose of the present study is to establish the efficacy and safety of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE in an alternate study population and to address the issue of peak time to response by measuring the proportion of patients achieving a ≥ 75% reduction in PASI at any time after completion of treatment.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Alefacept (Amevive)
- Keywords
- psoriasis, alefacept
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alefacept (Amevive)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE
Secondary outcomes (1)
To determine TRR50, Quality of Life (QOL), the safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startJan 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Uni-Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Investigators
- Po-Han Huang, Principal investigator, CGMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422617
- Sponsor's protocol ID
- ASIA-7002
- Status last verified
- Sep 2004
- First submitted
- 16 Jan 2007
- Last updated
- 17 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of One Course of Amevive in Taiwan Patients
- ClinicalTrials.gov ID
- NCT00422617
- Acronym / sponsor ID
- ASIA-7002
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- psoriasis, alefacept
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Uni-PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Jan 2005
- Study completion
- Nov 2005
- First posted
- 17 Jan 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.
An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis
Detailed description
The purpose of the present study is to establish the efficacy and safety of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE in an alternate study population and to address the issue of peak time to response by measuring the proportion of patients achieving a ≥ 75% reduction in PASI at any time after completion of treatment.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Must give written informed consent
- Must be >= 16 years of age
- Must have been diagnosed with chronic plaque psoriasis at least one year and require systemic or phototherapy
- Must have CD4+ lymphocyte count at or above the lower limit of normal
- Must have a BSA >= 10%
Key exclusion criteria (6 listed)
- Current erythrodermic, generalized pustular, or guttate psoriasis
- Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
- History of any clinical significant disease that would be contraindicated for this study as determined by the investigator
- Prior history of systemic malignancy, untreated localised skin canceer or a >10 squamous cell carcinoma
- Current enrollment in any other investigational drug study within 30 days prior to study 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 |
|---|---|---|
| Alefacept (Amevive) | Drug | – |
Primary outcome
To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE
1 secondary outcome
To determine TRR50, Quality of Life (QOL), the safety and tolerability
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 17 Jan 2007.
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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.
Po-Han Huang principal investigator
CGMH
Questions about this trial
What is this clinical trial studying?
A study testing Alefacept (Amevive) in people with Chronic Plaque Psoriasis, run by Uni-Pharma.
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 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 17 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
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 determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE. 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 17 Jan 2007.