NCT00658606

Brief Summary

Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on T cells

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2007

Typical duration for phase_4

Geographic Reach
1 country

12 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

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 22, 2011

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

April 10, 2008

Results QC Date

February 17, 2011

Last Update Submit

January 3, 2013

Conditions

Plaque Psoriasis

Keywords

plaque psoriasisalefaceptAmevivenarrow band ultraviolet Bphototherapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16

    The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.

    Week 16

Secondary Outcomes (10)

  • Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study

    Week 36

  • Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16

    Baseline and Week 16

  • Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study

    Baseline and Week 36

  • Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16

    Week 16

  • Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study

    Week 36

  • +5 more secondary outcomes

Study Arms (2)

Alefacept alone

ACTIVE COMPARATOR

15 mg alefacept intramuscularly (IM) once weekly for 12 weeks

Drug: alefacept

Alefacept + nbUVB

EXPERIMENTAL

15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks

Procedure: Narrow Band UVB Phototherapy

Interventions

alefaceptDRUG

IM

Also known as: Amevive, ASP0485
Alefacept alone
Narrow Band UVB PhototherapyPROCEDURE

UVB Phototherapy

Alefacept + nbUVB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has given written informed consent
  • Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving \>=10% with a Psoriasis Area and Severity Index (PASI) score \>=10 at Baseline
  • Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal
  • Male and female subjects must use an adequate means of contraception from screening to end of study.

You may not qualify if:

  • Subject who received alefacept in the past
  • Subject who has shown no improvement following an adequate course of nbUVB in the past
  • Subject who has been treated in the past with either therapy or cyclosporine
  • Subject with any active cancer, including skin cancer at Baseline
  • Subject with erythrodermic, pustular or predominantly guttate psoriasis
  • Subject who has used treatment for psoriasis prior to Baseline as follows:
  • Topical treatment within 14 days
  • Oral treatment within 28 days
  • Broad band UVB (bbUVB) or nbUVB treatment within 56 days
  • Biological treatment within 84 days
  • Serious local infection or serious systemic infection within the 3 months prior to the first dose of study drug
  • Subject with a history of drug or alcohol abuse within the past 2 years
  • Subject that is known to be infected with the AIDS virus
  • Subject with any other skin disease or other disease that might interfere with psoriasis status assessments
  • Female subject who is nursing, pregnant or planning to become pregnant while in this study
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Calgary, Alberta, T2S 3B3, Canada

Location

Unknown Facility

Surrey, British Columbia, V3R 6A7, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Unknown Facility

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

Unknown Facility

London, Ontario, N5X 2P1, Canada

Location

Unknown Facility

Markham, Ontario, L3P 1A8, Canada

Location

Unknown Facility

Toronto, Ontario, M5S 1B6, Canada

Location

Unknown Facility

Montreal, Quebec, H2K 4L5, Canada

Location

Unknown Facility

Montreal, Quebec, H3H 1V4, Canada

Location

Unknown Facility

Québec, Quebec, G1J 1X7, Canada

Location

Unknown Facility

Sainte-Foy, Quebec, G1V 4X7, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

  • Lui H, Gulliver W, Tan J, Hong CH, Hull P, Shear NH, Paradiso-Hardy F, Bissonette R. A randomized controlled study of combination therapy with alefacept and narrow band UVB phototherapy (UVB) for moderate to severe psoriasis: efficacy, onset, and duration of response. J Drugs Dermatol. 2012 Aug;11(8):929-37.

    PMID: 22859237BACKGROUND

Related Links

MeSH Terms

Interventions

Alefacept

Intervention Hierarchy (Ancestors)

CD58 AntigensMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesImmunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMembrane ProteinsRecombinant Fusion ProteinsRecombinant Proteins

Limitations and Caveats

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Results Point of Contact

Title
Director, Scientific Affairs
Organization
Astellas Pharma Canada, Inc.
ClinicalTrials@us.astellas.com

Study Officials

  • Use Central Contact

    Astellas Pharma Canada, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2008

First Posted

April 15, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 8, 2013

Results First Posted

April 22, 2011

Record last verified: 2013-01

Locations

CA(12)