Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis

This study has been completed.

Study NCT00332332 Information provided by Amgen

First Received on May 30, 2006. Last Updated on June 3, 2011 History of Changes

Results First Received: November 5, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Psoriasis
Intervention:	Biological: ENBREL (entanercept)

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
Participants were enrolled from 17 March 2006 through 30 June 2008

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
Etanercept	Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.

Participant Flow: Overall Study

	Etanercept
STARTED	246
Received Study Medication	230
COMPLETED	194
NOT COMPLETED	52
Adverse Event	13
Death	1
Withdrawal by Subject	8
Physician Decision	1
Lost to Follow-up	3
Protocol deviation	4
Noncompliance	2
Disease progression	2
Not specified	18

Baseline Characteristics

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Reporting Groups

	Description
Etanercept	Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.

Baseline Measures

	Etanercept
Number of Participants [units: participants]	230
Age [units: Year] Mean ± Standard Deviation	45.5 ± 11.5
Gender [units: Participant]
Female	95
Male	135
Race/Ethnicity, Customized [units: Participant]
Caucasian	215
Black	1
Asian	10
American Indian or Alaska Native	1
Aborigine	1
Other	2
Patient Global Assessment ^[1] [units: Units on a scale] Mean ± Standard Deviation	4.0 ± 0.8
Body Surface Area ^[2] [units: m^2] Mean ± Standard Deviation	27.4 ± 21.3
Dermatology Quality of Life Index Total Score ^[3] [units: Units on a scale] Mean ± Standard Deviation	13.7 ± 6.1

[1]	Patient global assessment of psoriasis scores range from 0 (good) to 5 (severe)
[2]	Body surface area affected by psoriasis
[3]	This score ranges from 0 to 30, with 0 = no effect and 30 = large effect

Outcome Measures

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1. Primary:

Status of Mild or Better on Physician Global Assessment at Month 12 [ Time Frame: Month 12 ]

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2. Secondary:

Percent Change From Baseline to Month 12 in Patient Global Assessment [ Time Frame: Baseline and Month 12 ]

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3. Secondary:

Percent Change From Baseline to Month 12 in Body Surface Area [ Time Frame: Baseline and Month 12 ]

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4. Secondary:

Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score [ Time Frame: Baseline and Month 12 ]

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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: The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.

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
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Results Point of Contact:

Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00332332 History of Changes
Other Study ID Numbers:	20050180
Study First Received:	May 30, 2006
Results First Received:	November 5, 2010
Last Updated:	June 3, 2011
Health Authority:	Canada: Health Canada