Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00725452
First received: July 25, 2008
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
Results First Received: June 13, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Psoriasis
Intervention: Biological: Infliximab

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[units: participants]
 		  26  
Age  
[units: years]
Mean ± Standard Deviation 		  46.23  ± 10.17  
Gender  
[units: participants]
 		 
Female     7  
Male     19  



  Outcome Measures
  Show All Outcome Measures

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

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

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

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

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

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 ]
  Show Outcome Measure 6


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.


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
No text entered.  


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


No publications provided


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00725452     History of Changes
Other Study ID Numbers: P04900
Study First Received: July 25, 2008
Results First Received: June 13, 2011
Last Updated: August 2, 2011
Health Authority: Austria: Not Required