Chronic Plaque PsoriasisAWARE-2NCT00795353
Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis
An observational study of Chronic Plaque Psoriasis, run by Astellas Pharma Inc at 21 sites in Canada.
Trial summary
The study is a prospective, multi-centre, observational study designed to assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe 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?
- Amevive exposure
- How many people
- 64 participants
- Where
- 21 sitesCanada
- Study dates
- Jul 2008to Jan 2011
- Phase
- Observational
- 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
Study population: Canadian subjects with moderate to severe chronic plaque psoriasis for which Amevive is clinically indicated
Who may be able to join
- Subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept
Who cannot join
- Subjects with a contraindication to alefacept
- Subjects with a history of cancer except for adequately treated basal cell carcinoma (maximum of 2 lesions)
- Subjects with any active cancer, including skin cancer
- Subjects having a serious local infection (eg. cellulitis, abscess) or serious systemic infection (eg. pneumonia, septicemia, tuberculosis), within the 3 months prior to the first dose of alefacept.
- Subjects known to be infected with the AIDS virus
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Canada21 sites
Study site
Alma, Quebec, G8B 2V5
Study site
Bathurst, New Brunswick, E1A 2YA
Study site
Edmonton, Alberta, T6J 5E5
Study site
Halifax, Nova Scotia, B3H 1Z4
Study site
Hamilton, Ontario, L8K 6R5
Study site
London, Ontario, N6A 3H7
Study site
London, Ontario, N6H 1S9
Study site
Markham, Ontario, L3P 1A8
Study site
Montreal, Quebec, H2K 4L5
Study site
Oakville, Ontario, L6J 7W5
Study site
Peterborough, Ontario, K9J 1Z2
Study site
Québec, Quebec, G1J 1X7
Study site
Quispamsis, New Brunswick, E2E 4Y7
Study site
Saint-Hyacinthe, Quebec, J2S 6L6
Study site
St. John's, Newfoundland and Labrador, A1B 3E1
Study site
St. John's, Newfoundland and Labrador, A1C 2H5
Study site
Toronto, Ontario, M4V2V6
Study site
Waterloo, Ontario, N2J 1C4
Study site
Welland, Ontario, L3C 3W4
Study site
Winnipeg, Manitoba, R3C 0N2
Study site
Winnipeg, Manitoba, R3C 1R4
About this study
Official title: Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study
The study is a prospective, multi-centre, observational study designed to assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis.
Read the detailed description
Study includes a bio-marker sub-study to determine differences in responders vs. non-responders. Additional consent is required for the sub-study.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Amevive exposure
- Keywords
- plaque psoriasis, psoriasis, alefacept, Amevive
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amevive exposureDrug
Also called alefacept, ASP0485
Commercial alefacept prescribed by Physician
| Study group | Role | What they receive |
|---|---|---|
| 1. Amevive Exposure | Canadian subjects with moderate to severe chronic plaque psoriasis Receives: Drug: Amevive exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis
Measured: 8 Weeks following last dose of each treatment course throughout study
Secondary outcomes (1)
Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index
Measured: 8 Weeks following last dose of each treatment course throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: The study was terminated early due to insufficient subject enrolment in order to meet the primary and secondary endpoints
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Canada, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795353
- Sponsor's protocol ID
- A.W.A.R.E.-2
- Acronym
- AWARE-2
- Status last verified
- Mar 2011
- First submitted
- 11 Nov 2008
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study
- ClinicalTrials.gov ID
- NCT00795353
- Acronym / sponsor ID
- AWARE-2 / A.W.A.R.E.-2
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- plaque psoriasis, psoriasis, alefacept, Amevive
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to insufficient subject enrolment in order to meet the primary and secondary endpoints
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Study start
- Jul 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 21 Nov 2008 (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 study is a prospective, multi-centre, observational study designed to assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis.
Detailed description
Study includes a bio-marker sub-study to determine differences in responders vs. non-responders. Additional consent is required for the sub-study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. Amevive Exposure | – | Drug: Amevive exposureCanadian subjects with moderate to severe chronic plaque psoriasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Canadian subjects with moderate to severe chronic plaque psoriasis for which Amevive is clinically indicated
Key inclusion criteria (1 listed)
- Subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept
Key exclusion criteria (5 listed)
- Subjects with a contraindication to alefacept
- Subjects with a history of cancer except for adequately treated basal cell carcinoma (maximum of 2 lesions)
- Subjects with any active cancer, including skin cancer
- Subjects having a serious local infection (eg. cellulitis, abscess) or serious systemic infection (eg. pneumonia, septicemia, tuberculosis), within the 3 months prior to the first dose of alefacept.
- Subjects known to be infected with the AIDS virus
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 |
|---|---|---|
| Amevive exposureAlso: alefacept, ASP0485Commercial alefacept prescribed by Physician | Drug | 1. Amevive Exposure |
Primary outcome
Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis
Time frame: 8 Weeks following last dose of each treatment course throughout study
1 secondary outcome
Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index
Time frame: 8 Weeks following last dose of each treatment course throughout study
Results and safety
The study was stopped early (reason given: The study was terminated early due to insufficient subject enrolment in order to meet the primary and secondary endpoints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
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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 Canada, Inc.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Plaque Psoriasis, run by Astellas Pharma Inc at 21 sites in Canada.
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 5 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: stopped early, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in 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.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to insufficient subject enrolment in order to meet the primary and secondary endpoints). 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?
Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis (time frame: 8 Weeks following last dose of each treatment course throughout study). 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 28 Feb 2013.