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

This study has been completed.

Study NCT00658606 Information provided by Astellas Pharma Inc

First Received on April 10, 2008. Last Updated on March 28, 2011 History of Changes

Results First Received: February 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Chronic Small Plaque Psoriasis
Interventions:	Drug: alefacept Procedure: Narrow Band UVB Phototherapy

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Alefacept Alone	15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
Alefacept + nbUVB	15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks

Participant Flow: Overall Study

	Alefacept Alone	Alefacept + nbUVB
STARTED	49	49
Completed Treatment	42	44
COMPLETED	33 ^[1]	26 ^[1]
NOT COMPLETED	16	23
Adverse Event	2	1
Lack of Efficacy	6	3
Lost to Follow-up	1	0
Withdrawal by Subject	7	16
Lack of Compliance	0	3

[1]	Represents patients who completed follow-up

Baseline Characteristics

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Reporting Groups

	Description
Alefacept Alone	15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
Alefacept + nbUVB	15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks

Baseline Measures

	Alefacept Alone	Alefacept + nbUVB	Total
Number of Participants [units: participants]	49	49	98
Age [units: years] Mean ± Standard Deviation	48.2 ± 13.8	47.1 ± 14.2	47.7 ± 14.0
Gender [units: participants]
Female	12	17	29
Male	37	32	69
Race/Ethnicity, Customized [units: participants]
Asian	5	6	11
Black	0	1	1
Caucasian	43	42	85
Other	1	0	1
PGA Score ^[1] [units: Score] Mean ± Standard Deviation	3.3 ± 0.7	3.4 ± 0.6	3.3 ± 0.6
BSA Score ^[2] [units: Percentage of BSA] Mean ± Standard Deviation	21.9 ± 13.0	20.0 ± 9.4	21.0 ± 11.3
DLQI Score ^[3] [units: Score] Mean ± Standard Deviation	6.1 ± 10	5.9 ± 7	6.1 ± 9
PASI Score ^[4] [units: Score] Mean ± Standard Deviation	17.8 ± 6.0	17.5 ± 5.2	17.7 ± 5.6

[1]	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).
[2]	The percentage of Body Surface Area (BSA) covered with Psoriasis.
[3]	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).
[4]	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).

Outcome Measures

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1. Primary:

Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16 [ Time Frame: Week 16 ]

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2. Secondary:

Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study [ Time Frame: Week 36 ]

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3. Secondary:

Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16 [ Time Frame: Baseline and Week 16 ]

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4. Secondary:

Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study [ Time Frame: Baseline and Week 36 ]

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5. Secondary:

Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16 [ Time Frame: Week 16 ]

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6. Secondary:

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 ]

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7. Secondary:

Percentage of Subjects Who Achieve PASI 90 at Week 16 [ Time Frame: Week 16 ]

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8. Secondary:

Time to Relapse [ Time Frame: Week 36 ]

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9. Secondary:

Time for 50% Decrease in PASI [ Time Frame: Week 36 ]

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10. Secondary:

Time for a 75% Decrease in PASI [ Time Frame: Week 36 ]

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11. Secondary:

Change in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline and Week 36 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Director, Scientific Affairs
Organization: Astellas Pharma Canada, Inc.
e-mail: ClinicalTrials@us.astellas.com

No publications provided

Responsible Party:	Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier:	NCT00658606 History of Changes
Other Study ID Numbers:	AME-001
Study First Received:	April 10, 2008
Results First Received:	February 17, 2011
Last Updated:	March 28, 2011
Health Authority:	Canada: Health Canada