Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00195507

First received: September 13, 2005

Last updated: February 20, 2013

Last verified: April 2010

History of Changes

Results First Received: March 31, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Psoriasis
Intervention:	Drug: Etanercept

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
Subjects were recruited in multiple countries worldwide from to.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened up to 4 weeks.

Reporting Groups

	Description
Continuous	etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
Intermittent	etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.

Participant Flow: Overall Study

	Continuous	Intermittent
STARTED	357	363
COMPLETED	258	245
NOT COMPLETED	99	118
Adverse Event	24	13
Death	0	1
Failed to Return	4	3
Physician Decision	1	2
Lost to Follow-up	3	2
Protocol Violation	5	4
Lack of Efficacy	40	67
Withdrawal by Subject	16	23
Protocol Deviation	6	3

Baseline Characteristics

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Reporting Groups

	Description
Continuous	etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
Intermittent	etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
Total	Total of all reporting groups

Baseline Measures

	Continuous	Intermittent	Total
Number of Participants [units: participants]	357	363	720
Age [units: years] Mean ± Standard Deviation	44.87 ± 11.83	45.20 ± 11.88	45.03 ± 11.85
Gender [units: participants]
Female	101	102	203
Male	256	261	517
Region of Enrollment [units: participants]
Portugal	6	6	12
Greece	9	8	17
Finland	5	5	10
Spain	19	19	38
Turkey	7	11	18
Austria	13	11	24
United Kingdom	59	60	119
Switzerland	4	3	7
Italy	40	39	79
France	50	52	102
Czech Republic	3	3	6
Hungary	2	3	5
Belgium	22	21	43
Poland	5	5	10
Denmark	10	9	19
Netherlands	23	25	48
Germany	57	58	115
Norway	7	8	15
Sweden	16	17	33

Outcome Measures

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1. Primary:

Physician Global Assessment of Psoriasis (PGA) Score – Mean Value Over 54 Weeks [ Time Frame: 54 weeks ]

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2. Secondary:

Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline [ Time Frame: 54 weeks ]

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3. Secondary:

Time to Achieve a Physician Global Assessment of Psoriasis Score of “Clear” or “Almost Clear” [ Time Frame: 54 weeks ]

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4. Secondary:

Number of Patients With Survey Response of “Somewhat Satisfied” or Better [ Time Frame: 54 weeks ]

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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 PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, 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
No text entered.

Results Point of Contact:

Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com

No publications provided

ClinicalTrials.gov Identifier:	NCT00195507 History of Changes
Other Study ID Numbers:	0881A6-101764
Study First Received:	September 13, 2005
Results First Received:	March 31, 2009
Last Updated:	February 20, 2013
Health Authority:	European Union: European Medicines Agency

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