A Study to Assess the Effect of Ustekinumab (Stelara®) and Etanercept (Enbrel®) in Participants With Moderate to Severe Psoriasis (MK-0000-206)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01276847

First received: January 12, 2011

Last updated: January 24, 2013

Last verified: January 2013

History of Changes

Results First Received: November 19, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Psoriasis
Interventions:	Drug: Ustekinumab 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
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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
Etanercept	Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
No Treatment	No treatment administered
Ustekinumab	Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16

Participant Flow: Overall Study

	Etanercept	No Treatment	Ustekinumab
STARTED	10	10	20
COMPLETED	9	10	20
NOT COMPLETED	1	0	0
Withdrawal by Subject	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Etanercept	Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
No Treatment	No treatment administered
Ustekinumab	Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
Total	Total of all reporting groups

Baseline Measures

	Etanercept	No Treatment	Ustekinumab	Total
Number of Participants [units: participants]	10	10	20	40
Age [units: years] Mean ± Standard Deviation	39.5 ± 12.5	53.4 ± 13.0	45.7 ± 12.1	46.1 ± 13.1
Gender [units: participants]
Female	4	1	7	12
Male	6	9	13	28

Outcome Measures

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1. Primary:

Change From Baseline in Composite Gene Expression Score Based on IL-12 Pathway Related Interferon Gamma (IFN-γ)-Modulated Genes in Psoriatic Lesions of Participants Treated With Ustekinumab [ Time Frame: Baseline and Weeks 1, 2, 4, and 16 ]

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2. Secondary:

Change From Baseline in Composite Gene Expression Score Based on Interleukin 23 (IL-23) Pathway Related Genes in Psoriatic Lesions of Participants Treated With Ustekinumab [ Time Frame: Baseline and Weeks 1, 2, 4, and 16 ]

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3. Secondary:

Change From Baseline in Gene Expression Score for Interleukin 17 (IL-17) in Psoriatic Lesions of Participants Treated With Etanercept [ Time Frame: Baseline and Weeks 1, 2, 4, and 16 ]

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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 SPONSOR must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.

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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01276847 History of Changes
Other Study ID Numbers:	MK-0000-206
Study First Received:	January 12, 2011
Results First Received:	November 19, 2012
Last Updated:	January 24, 2013
Health Authority:	United States: Institutional Review Board

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