PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept

This study has been completed.

Study NCT00527072 Information provided by Centocor Ortho Biotech Services, L.L.C.

First Received on September 6, 2007. Last Updated on May 28, 2010 History of Changes

Results First Received: May 28, 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: 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
A total of 217 subjects enrolled into the study but 2 subjects did not receive any study medication so they were excluded from analysis.

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	Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.

Participant Flow: Overall Study

	Infliximab
STARTED	215
COMPLETED	179
NOT COMPLETED	36
Adverse Event	13
Lack of Efficacy	11
Lost to Follow-up	3
Protocol Violation	2
Withdrawal by Subject	7

Baseline Characteristics

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Reporting Groups

	Description
Infliximab	Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.

Baseline Measures

	Infliximab
Number of Participants [units: participants]	215
Age [units: participants]
<=18 years	1
Between 18 and 65 years	198
>=65 years	16
Age [units: years] Mean ± Standard Deviation	44.4 ± 13.32
Gender [units: participants]
Female	78
Male	137

Outcome Measures

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1. Primary:

Number (Percent) of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0) [ Time Frame: Week 10 ]

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2. Secondary:

Number (Percent) of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response [ Time Frame: Weeks 10 ]

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3. Secondary:

Number (Percent) of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response [ Time Frame: Week 26 ]

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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.

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: Sr. Director, Clinical Research - Medical Affairs
Organization: Centocor Ortho Biotech, Inc.
phone: 215-325-5711

No publications provided

Responsible Party:	Sr. Director, Clinical Research - Medical Affairs, Centocor Inc.
ClinicalTrials.gov Identifier:	NCT00527072 History of Changes
Other Study ID Numbers:	CR014500, C0168Z04
Study First Received:	September 6, 2007
Results First Received:	May 28, 2010
Last Updated:	May 28, 2010
Health Authority:	United States: Food and Drug Administration