Plaque PsoriasisNCT00371774
Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program
An observational study of Plaque Psoriasis, run by Astellas Pharma Inc at 30 sites in Canada.
Trial summary
Purpose: To develop a real time national clinical database to support and share best practices, 1. To generate hypotheses for future clinical research 2. To understand how AMEVIVE is used in routine clinical practice/real world setting. Each patient visit will include the following observational endpoints: 1. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Plaque Psoriasis
- How many people
- 426 participants
- Where
- 30 sitesCanada
- Study dates
- Jun 2005to May 2008
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Dermatologic patients in Canada
Who may be able to join
- Amevive is clinically indicated for the patient
Who cannot join
- Amevive is contraindicated for the patient
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Canada30 sites
Study site
Barrie, Ontario, L7M 6L7
Study site
Calgary, Alberta, T2S 3B3
Study site
Calgary, Alberta, T3A 2N1
Study site
Concord, Ontario, L4K 5V2
Study site
Edmonton, Alberta, T5J 3S9
Study site
Edmonton, Alberta, T5K 1X3
Study site
Halifax, Nova Scotia, B3H 124
Study site
Hamilton, Ontario, L8N 3H7
Study site
London, Ontario, N6A 3H7
Study site
London, Ontario, N6H 1S9
Study site
Markham, Ontario, L3P 1A8
Study site
Moncton, New Brunswick, E1C 8X3
Study site
Montreal, Quebec, H2K 4L5
Study site
Montreal, Quebec, H3G 1A1
Study site
Oakville, Ontario, L6K 1E1
Study site
Québec, Quebec, G1J 1X7
Study site
Saint John, New Brunswick, E2M 3W5
Study site
Sainte-Foy, Quebec, G1V 4X7
Study site
St. John's, Newfoundland and Labrador, A1B 3A1
Study site
St. John's, Newfoundland and Labrador, A1B 3E1
Study site
St. John's, Newfoundland and Labrador, A1B 4S8
Study site
Surrey, British Columbia, V3R6A7
Study site
Toronto, Ontario, M5S 1B6
Study site
Vancouver, British Columbia, V5Z 3Y1
Study site
Vancouver, British Columbia, V5Z 4E8
Study site
Victoria, British Columbia, V8V 3P9
Study site
Victoria, British Columbia, V8V 4X3
Study site
Waterloo, Ontario, N2J 1C4
Study site
Windsor, Ontario, N8W 5L7
Study site
Winnipeg, Manitoba, R3C 1R4
About this study
Purpose:
To develop a real time national clinical database to support and share best practices,
- To generate hypotheses for future clinical research
- To understand how AMEVIVE is used in routine clinical practice/real world setting.
Each patient visit will include the following observational endpoints:
- AMEVIVE dosing
- Number of courses
- Concomitant treatment
- Response to treatment (patient and physician global assessments)
- Status of other psoriasis-related medical conditions
- Time to re-treatment.
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, Plaque Psoriasis, Amevive®, alefacept
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Dermatologic patients in Canada for which Amevive is clinically indicated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand how AMEVIVE is used in routine clinical practice/real world setting
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 posted4 Sep 2006 (estimated)
- Study startJun 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- 426 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 Canada, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371774
- Sponsor's protocol ID
- CA-08
- Status last verified
- Nov 2011
- First submitted
- 31 Aug 2006
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Searles G, Bissonnette R, Landells I, Shear NH. Preface: real-world clinical experience with alefacept-the Amevive Wisdom Acquired from Real-World Evidence (AWARE) study. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S107-12. doi: 10.2310/7750.2009.00028. No abstract available.
PubMed 20053322Bissonnette R, Searles G, Landells I, Shear NH, Papp K, Lui H, Gulliver WP, Lynde C. The AWARE study: methodology and baseline characteristics. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S113-21. doi: 10.2310/7750.2009.00029.
PubMed 20053323Landells I, Searles G, Bissonnette R, Shear NH, Vender R, Lui H. Efficacy outcomes in patients using alefacept in the AWARE study. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S122-30. doi: 10.2310/7750.2009.00030.
PubMed 20053324Searles G, Bissonnette R, Landells I, Shear NH, Papp K, Lui H. Patterns of combination therapy with alefacept for the treatment of psoriasis in Canada in the AWARE study. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S131-8. doi: 10.2310/7750.2009.00031.
PubMed 20053325Wexler D, Searles G, Landells I, Shear NH, Bissonnette R, Papp K, Poulin Y, Langley R, Gulliver WP. Update on alefacept safety. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S139-47. doi: 10.2310/7750.2009.00032.
PubMed 20053326
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program
- ClinicalTrials.gov ID
- NCT00371774
- Acronym / sponsor ID
- CA-08
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, Plaque Psoriasis, Amevive®, alefacept
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 Sep 2006 (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.
Purpose:
To develop a real time national clinical database to support and share best practices,
- To generate hypotheses for future clinical research
- To understand how AMEVIVE is used in routine clinical practice/real world setting.
Each patient visit will include the following observational endpoints:
- AMEVIVE dosing
- Number of courses
- Concomitant treatment
- Response to treatment (patient and physician global assessments)
- Status of other psoriasis-related medical conditions
- Time to re-treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Dermatologic patients in Canada for which Amevive is clinically indicated |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Dermatologic patients in Canada
Key inclusion criteria (1 listed)
- Amevive is clinically indicated for the patient
Key exclusion criteria (1 listed)
- Amevive is contraindicated for the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Understand how AMEVIVE is used in routine clinical practice/real world setting
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 17 Nov 2011.
- Background: PubMed 20053322Searles G, Bissonnette R, Landells I, Shear NH. Preface: real-world clinical experience with alefacept-the Amevive Wisdom Acquired from Real-World Evidence (AWARE) study. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S107-12. doi: 10.2310/7750.2009.00028. No abstract available.
- Background: PubMed 20053323Bissonnette R, Searles G, Landells I, Shear NH, Papp K, Lui H, Gulliver WP, Lynde C. The AWARE study: methodology and baseline characteristics. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S113-21. doi: 10.2310/7750.2009.00029.
- Background: PubMed 20053324Landells I, Searles G, Bissonnette R, Shear NH, Vender R, Lui H. Efficacy outcomes in patients using alefacept in the AWARE study. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S122-30. doi: 10.2310/7750.2009.00030.
- Background: PubMed 20053325Searles G, Bissonnette R, Landells I, Shear NH, Papp K, Lui H. Patterns of combination therapy with alefacept for the treatment of psoriasis in Canada in the AWARE study. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S131-8. doi: 10.2310/7750.2009.00031.
- Background: PubMed 20053326Wexler D, Searles G, Landells I, Shear NH, Bissonnette R, Papp K, Poulin Y, Langley R, Gulliver WP. Update on alefacept safety. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S139-47. doi: 10.2310/7750.2009.00032.
- Link to FDA WebsiteLink provided by the sponsor.
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Astellas Pharma Inc at 30 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 1 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 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 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?
Understand how AMEVIVE is used in routine clinical practice/real world setting (time frame: End of study). 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 NCT00371774, which also lists 5 linked publications.
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 Nov 2011.