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NCT00371774 Clinical Trial

Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program

Plaque Psoriasis Clinical Trial

Official title:
Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00371774
Other study ID # CA-08
Secondary ID
Status Completed
Phase Phase 4
First received August 31, 2006
Last updated November 15, 2011
Start date June 2005
Est. completion date May 2008

Study information
Verified date November 2011
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical 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. 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.

Other known NCT identifiers
  • NCT00214799

Recruitment information / eligibility
Status Completed
Enrollment 426
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Amevive is clinically indicated for the patient

Exclusion Criteria:

- Amevive is contraindicated for the patient

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Understand how AMEVIVE is used in routine clinical practice/real world setting End of study No
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