Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP)(Study P04555)(COMPLETED) (TIPS)

This study has been completed.

Sponsor:

Collaborator:

Centocor, Inc.

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00686686

First received: May 27, 2008

Last updated: March 29, 2011

Last verified: March 2011

History of Changes

Results First Received: January 27, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Psoriasis
Intervention:	Biological: Infliximab

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
Infliximab 5 mg/kg	Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.

Participant Flow: Overall Study

	Infliximab 5 mg/kg
STARTED	23
COMPLETED	17
NOT COMPLETED	6
Non-compliance	1
Adverse Event	2
Lost to Follow-up	3

Baseline Characteristics

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Reporting Groups

	Description
Infliximab 5 mg/kg	Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.

Baseline Measures

	Infliximab 5 mg/kg
Number of Participants [units: participants]	23
Age [units: years] Mean ± Standard Deviation	45.5 ± 11.9
Gender [units: participants]
Female	13
Male	10

Outcome Measures

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1. Primary:

Number of Participants Who Achieve at Least 75% Improvement in Palmoplantar Psoriasis Activity Severity Index (PPPASI) After 3 Infusions. [ Time Frame: Baseline and Week 8 ]

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2. Secondary:

Number of Participants Who Achieve a Moderate Response. [ Time Frame: Baseline and Week 8 ]

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3. Secondary:

Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18. [ Time Frame: Weeks 12 and 18 ]

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4. Secondary:

Number of Participants Who Respond to the Fourth Infusion. [ Time Frame: Week 12 and Week 18 ]

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5. Secondary:

Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline and Week 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: All proposed publications/presentations by the investigators or their personnel resulting from or relating to this study must be submitted to Sponsor for review 60 days before submission for publication or presentation. If the proposed publication/presentation contains patentable subject matter which, at Sponsor’s sole discretion, warrants intellectual property protection, the Sponsor may delay any publication or presentation for up to 60 days for the purpose of pursuing such 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
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Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00686686 History of Changes
Other Study ID Numbers:	P04555
Study First Received:	May 27, 2008
Results First Received:	January 27, 2011
Last Updated:	March 29, 2011
Health Authority:	Israel: Ministry of Health Israel: Ethics Commission

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