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Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab (Study P05047) (PHODYPSO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00749398
First received: September 5, 2008
Last updated: August 12, 2014
Last verified: August 2014
Results First Received: August 31, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
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 Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.

Participant Flow:   Overall Study
    Infliximab  
STARTED     124 [1]
COMPLETED     71  
NOT COMPLETED     53  
Lack of Efficacy                 7  
Adverse Event                 4  
Serious adverse event                 11  
Withdrawal by Subject                 17  
Lost to Follow-up                 11  
Reason not specified                 2  
Unknown reason                 1  
[1] Nine participants were excluded because they did not fulfill the inclusion criteria.



  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.
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Reporting Groups
  Description
Infliximab Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.

Baseline Measures
    Infliximab  
Number of Participants  
[units: participants]
  124  
Age  
[units: years]
Mean ± Standard Deviation
  46.9  ± 13.7  
Gender  
[units: participants]
 
Female     45  
Male     79  



  Outcome Measures
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1.  Primary:   Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists   [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ]

2.  Primary:   Dynamic Photographic PGA Score as Assessed by Two Dermatologists   [ Time Frame: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) ]

3.  Secondary:   Static PGA Score as Assessed by the Investigator   [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ]

4.  Secondary:   Dynamic PGA Score as Assessed by the Investigator   [ Time Frame: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) ]

5.  Secondary:   Percent Body Surface Area (BSA) Involved With Psoriasis   [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6) ]

6.  Secondary:   Psoriasis Area and Severity Index (PASI) Score   [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ]

7.  Secondary:   Nail Psoriasis Severity Index (NAPSI) Score   [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ]

8.  Secondary:   Static PGA Score as Assessed by the Participant   [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ]

9.  Secondary:   Dynamic PGA Score as Assessed by the Participant   [ Time Frame: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6) ]

10.  Secondary:   Dermatology Life Quality Index (DLQI) Score   [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ]

11.  Secondary:   Number of Participants With Satisfactory Health Status   [ Time Frame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6) ]


  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 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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00749398     History of Changes
Other Study ID Numbers: P05047
Study First Received: September 5, 2008
Results First Received: August 31, 2011
Last Updated: August 12, 2014
Health Authority: France: Not Applicable