NCT00371774

Brief Summary

Purpose: To develop a real time national clinical database to support and share best practices,

  1. 1.To generate hypotheses for future clinical research
  2. 2.To understand how AMEVIVE is used in routine clinical practice/real world setting.
  3. 3.AMEVIVE dosing
  4. 4.Number of courses
  5. 5.Concomitant treatment
  6. 6.Response to treatment (patient and physician global assessments)
  7. 7.Status of other psoriasis-related medical conditions
  8. 8.Time to re-treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Typical duration for all trials

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 17, 2011

Status Verified

November 1, 2011

Enrollment Period

2.9 years

First QC Date

August 31, 2006

Last Update Submit

November 15, 2011

Conditions

Keywords

PsoriasisPlaque PsoriasisAmevive®alefacept

Outcome Measures

Primary Outcomes (1)

  • Understand how AMEVIVE is used in routine clinical practice/real world setting

    End of study

Study Arms (1)

1

Dermatologic patients in Canada for which Amevive is clinically indicated

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dermatologic patients in Canada

You may qualify if:

  • Amevive is clinically indicated for the patient

You may not qualify if:

  • Amevive is contraindicated for the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Unknown Facility

Calgary, Alberta, T2S 3B3, Canada

Location

Unknown Facility

Calgary, Alberta, T3A 2N1, Canada

Location

Unknown Facility

Edmonton, Alberta, T5J 3S9, Canada

Location

Unknown Facility

Edmonton, Alberta, T5K 1X3, Canada

Location

Unknown Facility

Surrey, British Columbia, V3R6A7, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 3Y1, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Unknown Facility

Victoria, British Columbia, V8V 3P9, Canada

Location

Unknown Facility

Victoria, British Columbia, V8V 4X3, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3C 1R4, Canada

Location

Unknown Facility

Moncton, New Brunswick, E1C 8X3, Canada

Location

Unknown Facility

Saint John, New Brunswick, E2M 3W5, Canada

Location

Unknown Facility

St. John's, Newfoundland and Labrador, A1B 3A1, Canada

Location

Unknown Facility

St. John's, Newfoundland and Labrador, A1B 3E1, Canada

Location

Unknown Facility

St. John's, Newfoundland and Labrador, A1B 4S8, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3H 124, Canada

Location

Unknown Facility

Barrie, Ontario, L7M 6L7, Canada

Location

Unknown Facility

Concord, Ontario, L4K 5V2, Canada

Location

Unknown Facility

Hamilton, Ontario, L8N 3H7, Canada

Location

Unknown Facility

London, Ontario, N6A 3H7, Canada

Location

Unknown Facility

London, Ontario, N6H 1S9, Canada

Location

Unknown Facility

Markham, Ontario, L3P 1A8, Canada

Location

Unknown Facility

Oakville, Ontario, L6K 1E1, Canada

Location

Unknown Facility

Toronto, Ontario, M5S 1B6, Canada

Location

Unknown Facility

Waterloo, Ontario, N2J 1C4, Canada

Location

Unknown Facility

Windsor, Ontario, N8W 5L7, Canada

Location

Unknown Facility

Montreal, Quebec, H2K 4L5, Canada

Location

Unknown Facility

Montreal, Quebec, H3G 1A1, Canada

Location

Unknown Facility

Québec, Quebec, G1J 1X7, Canada

Location

Unknown Facility

Sainte-Foy, Quebec, G1V 4X7, Canada

Location

Related Publications (5)

  • 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.

    PMID: 20053322BACKGROUND
  • 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.

    PMID: 20053323BACKGROUND
  • 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.

    PMID: 20053324BACKGROUND
  • 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.

    PMID: 20053325BACKGROUND
  • 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.

    PMID: 20053326BACKGROUND

Related Links

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Use Central Contact

    Astellas Pharma Canada, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

June 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 17, 2011

Record last verified: 2011-11

Locations