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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:
NCT00527072
First received: September 6, 2007
Last updated: August 28, 2012
Last verified: August 2012
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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
  Show All Outcome Measures

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

2.  Secondary:   Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10   [ Time Frame: Week 10 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sr. Director, Clinical Research - Medical Affairs
Organization: Janssen Biotech, Inc.
phone: 215-325-5711


No publications provided by Centocor Ortho Biotech Services, L.L.C.

Publications automatically indexed to this study:

Responsible Party: Centocor Ortho Biotech Services, L.L.C.
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: August 28, 2012
Health Authority: United States: Food and Drug Administration