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NCT00795353 Clinical Trial

Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Chronic Plaque Psoriasis Clinical Trial

— AWARE-2  

Official title:
Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00795353
Other study ID # A.W.A.R.E.-2
Secondary ID
Status Terminated
Phase N/A
First received November 11, 2008
Last updated February 27, 2013
Start date July 2008
Est. completion date January 2011

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

Clinical 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.

Description:

Study includes a bio-marker sub-study to determine differences in responders vs. non-responders. Additional consent is required for the sub-study.

Recruitment information / eligibility
Status Terminated
Enrollment 64
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept

Exclusion Criteria:

- 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Amevive exposure
Commercial alefacept prescribed by Physician

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma Canada, Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis 8 Weeks following last dose of each treatment course throughout study No
Secondary Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index 8 Weeks following last dose of each treatment course throughout study No
See also
  Status Clinical Trial Phase
Completed NCT03598790 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3
Completed NCT00799877 - Chronic Plaque Psoriasis (Ps) Registry
Completed NCT02581345 - Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis Phase 3
Withdrawn NCT01200264 - Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy Phase 2
Not yet recruiting NCT00707070 - Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis Phase 4
Terminated NCT00972543 - Raptiva in Palm and Sole Psoriasis Phase 4
Completed NCT00539929 - Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis Phase 2
Completed NCT02852967 - A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis Phase 2
Completed NCT00770965 - Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis Phase 2
Active, not recruiting NCT06011733 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT00245765 - Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy Phase 2
Completed NCT00673556 - A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate Phase 3
Terminated NCT00844363 - Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris N/A
Completed NCT00574249 - Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment Phase 3
Completed NCT00512187 - Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial Phase 4
Completed NCT02570750 - The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Completed NCT00438360 - Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis Phase 3
Active, not recruiting NCT03897075 - Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis Phase 3
Completed NCT01358578 - Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis Phase 3
Completed NCT03536884 - A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3

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