Community Based Trial for AMEVIVE®

Moderate to Severe Chronic Plaque Psoriasis Clinical Trial

Official title:

An Open-Label Community-Based Study to Determine the Safety and Efficacy of an Extended Course of Alefacept, Following a Standard 12-Week Course of Amevive®, With Commonly Used Clinical Assessment Tools

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168753
• Other study ID #: IST-US-064-04-AME
• Secondary ID: CBT/IST 64
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: September 5, 2014
• Start date: July 2004
• Est. completion date: March 2005

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.

Description:

Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response.

Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Must give written informed consent.

2. Must have had moderate, moderately severe or severe chronic plaque psoriasis as determined by the investigator prior to initial treatment (baseline) with AMEVIVE.

3. Must be 18 years of age or older.

4. Must have completed a standard 12-week course of AMEVIVE and have received at least 10 doses.

5. Response to current AMEVIVE therapy must be less than a desired response as determined by the physician, and subject and some residual psoriasis must be present.

Exclusion Criteria:

1. Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or not willing to practice effective contraception during the study.

2. Nursing mothers, pregnant women, and women planning to become pregnant

3. Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.

4. Treatment with another investigational drug, or approved therapy for investigational use, within 3 months of investigational drug administration.

5. Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mycophenolate mofetil or other systemic immunosuppressant agents within 4 weeks of investigational drug administration.

6. Treatment with Ultraviolet B (UVB) phototherapy or Psoralen + Ultraviolet A (PUVA), within 4 weeks of investigational drug administration.

7. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.

8. History of >3 cutaneous squamous cell carcinomas or any systemic malignancy.

9. Skin lesions suspicious for malignancy.

10. Known HIV, viral hepatitis, or tuberculosis infection.

11. History of severe allergic or anaphylactic reactions.

12. ALT or AST greater than three times the upper limit of normal.

13. Significantly abnormal hematology (hemoglobin, hematocrit, platelets, white blood cells), as determined by the investigator.

14. CD4+ T lymphocyte count at screening visit less than 250 cells/mm3.

15. Known hypersensitivity to AMEVIVE or any of its components.

16. Subject's inability to comply with study requirements.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moderate to Severe Chronic Plaque Psoriasis

Intervention

Drug:
• Alefacept
IM

Locations

Country	Name	City	State
United States	Pearlridge Dermatology	Aiea	Hawaii
United States	Atlanta Derm, Vein & Research Center	Alpharetta	Georgia
United States	Jayne Fortson	Anchorage	Alaska
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	Bakersfield Dermatology & Skin Cancer Medical Group	Bakersfield	California
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	Dermatology & Laser Center	Bellingham	Washington
United States	Monheit Dermatology Associates	Birmingham	Alabama
United States	Calumet Dermatology Associates	Calumet City	Illinois
United States	Melissa Knuckles	Corbin	Kentucky
United States	Texas Dermatology Research	Dallas	Texas
United States	Front Dermatology	Denver	Colorado
United States	Jerry Bagel	East Windsor	New Jersey
United States	Michael Greenberg	Elk Grove Village	Illinois
United States	Bayshore Dermatology	Fairhope	Alabama
United States	Psoriasis Treatment Center	Grand Rapids	Michigan
United States	Dermatology Associates of Knoxville	Knoxville	Tennessee
United States	Woodson Clinical Studies Group, Inc.	Las Vegas	Nevada
United States	Mark Wallis	Longview	Texas
United States	Catskill Dermatology	Monticello	New York
United States	Nashua Dermatology	Nashua	New Hampshire
United States	Gold Skin Care	Nashville	Tennessee
United States	David J. Coynik	Peru	Illinois
United States	Richard Eisen	Plymouth	Massachusetts
United States	Dermatology Assoc of Plymouth Meeting	Plymouth Meeting	Pennsylvania
United States	Integrated Research Group	Riverside	California
United States	Dermatology & Laser Center of Roseberg	Roseburg	Oregon
United States	Stephen Miller	San Antonio	Texas
United States	Robert Greenberg	San Ramon	California
United States	Marina I Peredo	Smithtown	New York
United States	Skin and Cancer Associates	Tamarac	Florida
United States	Michael Scannon	Tampa	Florida
United States	Robert Brodell	Warren	Ohio
United States	Buffalo Medical Group	Williamsville	New York
United States	Wilmington Health Associates Dermatology	Wilmington	North Carolina
United States	Stephen Flax	Winchester	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE.		16 weeks, 20 weeks or 24 weeks	No
Secondary	The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,		End of study	No
Secondary	The cumulative change in PQA score from screening visit to best PQA score at any time in the study,		End of study	No
Secondary	Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study,		End of study	No
Secondary	Time to re-treatment for subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,		End of study	No
Secondary	The cumulative change in SSA score from screening visit to best SSA score at any time in the study,		End of study	No
Secondary	Association of the total number of doses received with the best efficacy reached, as assessed by SSA score, at any time during the study, and		End of study	No
Secondary	Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively.		End of study	No

External Links

•   Link to Results on JAPIC - enter 140573 in the JapicCTI-RNo. field