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| Name | Class |
|---|---|
| Astellas Pharma Canada, Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alefacept alone | Active Comparator | 15 mg alefacept intramuscularly (IM) once weekly for 12 weeks |
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| Alefacept + nbUVB | Experimental | 15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alefacept | Drug | IM |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Canada, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calgary | Alberta | T2S 3B3 | Canada | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22859237 | Background | 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. |
| Label | URL |
|---|---|
| Link to Prescribing Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alefacept Alone | 15 mg alefacept intramuscularly (IM) once weekly for 12 weeks |
| FG001 | Alefacept + nbUVB | 15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Narrow Band UVB Phototherapy | Procedure | UVB Phototherapy |
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| Week 36 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Surrey |
| British Columbia |
| V3R 6A7 |
| Canada |
| Vancouver | British Columbia | V5Z 4E8 | Canada |
| St. John's | Newfoundland and Labrador | A1C 2H5 | Canada |
| London | Ontario | N5X 2P1 | Canada |
| Markham | Ontario | L3P 1A8 | Canada |
| Toronto | Ontario | M5S 1B6 | Canada |
| Montreal | Quebec | H2K 4L5 | Canada |
| Montreal | Quebec | H3H 1V4 | Canada |
| Québec | Quebec | G1J 1X7 | Canada |
| Sainte-Foy | Quebec | G1V 4X7 | Canada |
| Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Completed Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alefacept Alone | 15 mg alefacept intramuscularly (IM) once weekly for 12 weeks |
| BG001 | Alefacept + nbUVB | 15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| PGA Score | 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). | Mean | Standard Deviation | Score |
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| BSA Score | The percentage of Body Surface Area (BSA) covered with Psoriasis. | Mean | Standard Deviation | Percentage of BSA |
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| DLQI Score | 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). | Mean | Standard Deviation | Score |
| ||||||||||||||
| PASI Score | 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). | Mean | Standard Deviation | Score |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). | Posted | Number | Percentage of Subjects | Week 16 |
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). Only subjects who completed follow-up were included in this analysis. | Posted | Number | Percentage of Subjects | Week 36 |
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). The number of participants per arm is consistent for all categories / rows of the data table. | Posted | Mean | Standard Deviation | Percentage of BSA | Baseline and Week 16 |
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). The number of participants per arm is consistent for all categories / rows of the data table. | Posted | Mean | Standard Deviation | Percentage of BSA | Baseline and Week 36 |
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). | Posted | Number | Percentage of Subjects | Week 16 |
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). | Posted | Number | Percentage of Subjects | Week 36 |
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). | Posted | Number | Percentage of Subjects | Week 16 |
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). Only subjects who achieved a 75% improvement in PASI and then relapsed were included in the analysis. | Posted | Mean | Standard Deviation | Days | Week 36 |
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). Only subjects who experienced a 50% decrease in PASI were included in the analysis. | Posted | Median | Inter-Quartile Range | Days | Week 36 |
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). Only subjects who experienced a 75% decrease in PASI were included in the analysis. | Posted | Mean | Inter-Quartile Range | Days | Week 36 |
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| 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. | The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). The number of participants per arm is consistent for all categories / rows of the data table. | Posted | Mean | Standard Deviation | DLQI Score | Baseline and Week 36 |
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From the time of Informed Consent through the last study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alefacept Alone | 15 mg alefacept intramuscularly (IM) once weekly for 12 weeks | 0 | 49 | 10 | 49 | ||
| EG001 | Alefacept + nbUVB | 15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks | 2 | 49 | 40 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema legs | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Cervical disc herniation | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Cervical cord compression | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common cold | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| CD4 lymphocytes decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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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.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Scientific Affairs | Astellas Pharma Canada, Inc. | ClinicalTrials@us.astellas.com |
| ID | Term |
|---|---|
| D000077944 | Alefacept |
| ID | Term |
|---|---|
| D018968 | CD58 Antigens |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008565 | Membrane Proteins |
| D011993 | Recombinant Fusion Proteins |
| D011994 | Recombinant Proteins |
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