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| ID | Type | Description | Link |
|---|---|---|---|
| 32547 Contract number |
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The purpose of this research study is to see how well the medication Alefacept (AmeviveĀ®) works for continuous treatment of chronic plaque psoriasis. The US Food and Drug Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg weekly injection for 12 weeks followed by 12 weeks off treatment.
To estimate the efficacy of continuous use of alefacept (15mg IM/week) in the treatment of moderate to severe chronic plaque type psoriasis as defined as Investigator Global Assessment (IGA) of 0 or 1 (clear or almost clear) or as a 75% reduction in Psoriasis Area and Severity Index (PASI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alefacept | Experimental | Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alefacept | Drug | Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks. Alefacept is supplied as a lyophilized powder. Alefacept contains LFA3-IgG1 Fusion Protein and excipient materials (citrate, glycine and sucrose). |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52 | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Alefacept Using CD4 Counts | Number of participants experiencing CD4 cell counts below 250/uL | 52 weeks |
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Inclusion Criteria:
Inclusion criteria of either:
IGAā„3 on a 0-5 scale and BSAā„10%
PASI ā„12
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Feldman, MD | Wake Forest University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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Fifteen subjects with moderate to severe chronic plaque type psoriasis were recruited from the Wake Forest University Health Sciences Dermatology Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Alefacept | All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alefacept | All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months |
| 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, Categorical | Count of Participants |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy | Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52 | Posted | Number | #Participants | 52 weeks |
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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 | All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low CD4 cell count | Immune system disorders | Non-systematic Assessment | CD4 cell count <250 cells/uL |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Feldman, MD, PhD | Wake Forest University Health Sciences | 336-716-3775 | sfeldman@wakehealth.edu |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077944 | Alefacept |
| ID | Term |
|---|---|
| D018968 | CD58 Antigens |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Safety of Alefacept Using CD4 Counts | Number of participants experiencing CD4 cell counts below 250/uL | Posted | Number | Participants | 52 weeks |
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| 2 |
| 15 |
| 8 |
| 15 |
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| Severe allergic contact dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Generalized muscle aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Breast tenderness | Reproductive system and breast disorders | Non-systematic Assessment |
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| Eye irritation | Eye disorders | Non-systematic Assessment |
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| Generalized itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| 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 |