Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects

Plaque Psoriasis Clinical Trial

Official title:

Efficacy and Safety of Alefacept in Combination With Narrow-band UVB (nbUVB) Compared to Alefacept Alone in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658606
• Other study ID #: AME-001
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2008
• Last updated: January 3, 2013
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Subject who is currently enrolled in any other investigational drug or device study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• alefacept
IM

Procedure:
• Narrow Band UVB Phototherapy
UVB Phototherapy

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, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study	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 36	No
Secondary	Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16	A negative change from Baseline represents improvement.; Change is calculated as Week 16- Baseline.; The Last Observation Carry Forward (LOCF) method was used to impute missing data.	Baseline and Week 16	No
Secondary	Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study	A negative change from Baseline represents improvement.; Change is calculated as Week 36- Baseline.; The Last Observation Carry Forward (LOCF) method was used to impute missing data.	Baseline and Week 36	No
Secondary	Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16	The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.; Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.; The Last Observation Carry Forward (LOCF) method was used to impute missing data.	Week 16	No
Secondary	Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study	The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.; Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.; The Last Observation Carry Forward (LOCF) method was used to impute missing data.	Week 36	No
Secondary	Percentage of Subjects Who Achieve PASI 90 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 90 was defined as an improvement of at least 90% in PASI as compared to Baseline.; The Last Observation Carry Forward (LOCF) method was used to impute missing data.	Week 16	No
Secondary	Time to Relapse	The analysis only included subjects who achieved a 75% improvement in PASI and then relapsed.; Relapse is defined by a loss of 50% of improvement in PASI.	Week 36	No
Secondary	Time for 50% Decrease in PASI	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).; Only subjects who experienced 50% decrease in PASI were included in the analysis.	Week 36	No
Secondary	Time for a 75% Decrease in PASI	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).; Only subjects who experienced 75% decrease in PASI were included in the analysis.	Week 36	No
Secondary	Change in Dermatology Life Quality Index (DLQI)	The DLQI questionnaire is intended to measure how much a subject's skin problem affects the subject's life. Subjects provide answers considering the past week. The scale of the DQLI ranges from 0 (best) to 30 (worst).; A negative change from Baseline represents improvement.; Change is calculated as Week 36- Baseline.; The Last Observation Carry Forward (LOCF) method was used to impute missing data.	Baseline and Week 36	No

External Links

•   Link to Prescribing Information