Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects
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| ClinicalTrials.gov Identifier: NCT00658606 |
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Recruitment Status :
Completed
First Posted : April 15, 2008
Results First Posted : April 22, 2011
Last Update Posted : January 8, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: alefacept Procedure: Narrow Band UVB Phototherapy | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 98 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | October 2007 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2009 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Alefacept alone
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
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Drug: alefacept
IM
Other Names:
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Experimental: Alefacept + nbUVB
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
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Procedure: Narrow Band UVB Phototherapy
UVB Phototherapy |
- Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16 [ Time Frame: 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.
- Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study [ Time Frame: Week 36 ]
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.
- Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16 [ Time Frame: Baseline and 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.
- Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study [ Time Frame: Baseline and Week 36 ]
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.
- Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16 [ Time Frame: 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.
- Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study [ Time Frame: Week 36 ]
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.
- Percentage of Subjects Who Achieve PASI 90 at Week 16 [ Time Frame: 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.
- Time to Relapse [ Time Frame: Week 36 ]
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.
- Time for 50% Decrease in PASI [ Time Frame: Week 36 ]
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.
- Time for a 75% Decrease in PASI [ Time Frame: Week 36 ]
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.
- Change in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline and Week 36 ]
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658606
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2S 3B3 | |
| Canada, British Columbia | |
| Surrey, British Columbia, Canada, V3R 6A7 | |
| Vancouver, British Columbia, Canada, V5Z 4E8 | |
| Canada, Newfoundland and Labrador | |
| St. John's, Newfoundland and Labrador, Canada, A1C 2H5 | |
| Canada, Ontario | |
| London, Ontario, Canada, N5X 2P1 | |
| Markham, Ontario, Canada, L3P 1A8 | |
| Toronto, Ontario, Canada, M5S 1B6 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H2K 4L5 | |
| Montreal, Quebec, Canada, H3H 1V4 | |
| Sainte-Foy, Quebec, Canada, G1V 4X7 | |
| Canada, Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Canada | |
| Quebec, Canada, G1J 1X7 | |
| Study Director: | Use Central Contact | Astellas Pharma Canada, Inc. |
Additional Information:
Publications:
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00658606 |
| Other Study ID Numbers: |
AME-001 |
| First Posted: | April 15, 2008 Key Record Dates |
| Results First Posted: | April 22, 2011 |
| Last Update Posted: | January 8, 2013 |
| Last Verified: | January 2013 |
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plaque psoriasis alefacept Amevive narrow band ultraviolet B phototherapy |
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Alefacept |
Dermatologic Agents Immunologic Factors Physiological Effects of Drugs |