Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects
NCT ID: NCT00658606
Last Updated: 2013-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
98 participants
INTERVENTIONAL
2007-10-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alefacept alone
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
alefacept
IM
Alefacept + nbUVB
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
Narrow Band UVB Phototherapy
UVB Phototherapy
Interventions
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alefacept
IM
Narrow Band UVB Phototherapy
UVB Phototherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Canada, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Canada, Inc.
Locations
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Calgary, Alberta, Canada
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
St. John's, Newfoundland and Labrador, Canada
London, Ontario, Canada
Markham, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sainte-Foy, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Countries
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References
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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.
Related Links
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Link to Prescribing Information
Other Identifiers
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AME-001
Identifier Type: -
Identifier Source: org_study_id
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