Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00725452
First received: July 25, 2008
Last updated: August 12, 2014
Last verified: August 2014
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

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  
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 ]

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
  Hide 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.


  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.


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: NCT00725452     History of Changes
Other Study ID Numbers: P04900
Study First Received: July 25, 2008
Results First Received: June 13, 2011
Last Updated: August 12, 2014
Health Authority: Austria: Not Required