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Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00725452
First Posted: July 30, 2008
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: June 13, 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
No text entered.

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 Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.

Participant Flow:   Overall Study
    Infliximab
STARTED   26 
COMPLETED   15 [1] 
NOT COMPLETED   11 
Adverse Event                3 
Lack of Efficacy                2 
Reason not specified                1 
Physician Decision                1 
Withdrawal by Subject                3 
Lost to Follow-up                1 
[1] Completed was defined as the number of participants who received 9 consecutive Infliximab infusions.



  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 Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.

Baseline Measures
   Infliximab 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.23  (10.17) 
Gender 
[Units: Participants]
 
Female   7 
Male   19 


  Outcome Measures
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1.  Primary:   Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab   [ Time Frame: Maximum 2 years ]

2.  Secondary:   Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy   [ Time Frame: Maximum 2 years ]

3.  Secondary:   Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy   [ Time Frame: Maximum 2 years ]

4.  Secondary:   Mean Dose of Infliximab   [ Time Frame: Maximum 2 years ]

5.  Secondary:   Median Dose of Infliximab   [ Time Frame: Maximum 2 years ]

6.  Secondary:   Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab   [ Time Frame: Baseline and Infusion 9 ]


  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 NOT 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.


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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725452     History of Changes
Other Study ID Numbers: P04900
First Submitted: July 25, 2008
First Posted: July 30, 2008
Results First Submitted: June 13, 2011
Results First Posted: September 2, 2011
Last Update Posted: July 28, 2015