Clinical trial NCT00371774: Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program
Official title: Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Plaque Psoriasis
Amevive®
alefacept
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-09-04
Enrollment: 426
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dermatologic patients in Canada

Brief 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. AMEVIVE dosing
2. Number of courses
3. Concomitant treatment
4. Response to treatment (patient and physician global assessments)
5. Status of other psoriasis-related medical conditions
6. Time to re-treatment.


Eligibility criteria: Inclusion Criteria:

* Amevive is clinically indicated for the patient

Exclusion Criteria:

* Amevive is contraindicated for the patient

Primary outcomes:
measure: Understand how AMEVIVE is used in routine clinical practice/real world setting
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Surrey
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Moncton
country: Canada
state: New Brunswick
city: Saint John
country: Canada
state: New Brunswick
city: St John's
country: Canada
state: Newfoundland and Labrador
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Barrie
country: Canada
state: Ontario
city: Concord
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: Quebec
country: Canada
Study officials:
affiliation: Astellas Pharma Canada, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bissonnette 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.
citation: Landells 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.
citation: Searles 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.
citation: Wexler 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.