Moderate to Severe Plaque Psoriasis With Scalp Involvement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00791765
First received: November 14, 2008
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: September 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Biological: Etanercept
Biological: Placebo

  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
Participants were enrolled from 5 December 2008 through 6 January 2010

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
Placebo BIW/Etanercept 50 mg BIW Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
Etanercept 50 mg BIW/Etanercept 50 mg QW Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.

Participant Flow for 2 periods

Period 1:   Weeks 1 to 12
    Placebo BIW/Etanercept 50 mg BIW     Etanercept 50 mg BIW/Etanercept 50 mg QW  
STARTED     62     62  
Treated     62     59  
COMPLETED     54     58  
NOT COMPLETED     8     4  
Adverse Event                 0                 1  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 3                 0  
Physician Decision                 1                 0  
Disease progression                 3                 0  
Ineligibility determined                 0                 3  

Period 2:   Weeks 13 to 24
    Placebo BIW/Etanercept 50 mg BIW     Etanercept 50 mg BIW/Etanercept 50 mg QW  
STARTED     54     57 [1]
COMPLETED     49     49  
NOT COMPLETED     5     8  
Protocol deviation                 2                 0  
Adverse Event                 0                 3  
Withdrawal by Subject                 2                 1  
Disease progression                 0                 1  
Lost to Follow-up                 1                 2  
Other                 0                 1  
[1] 1 participant discontinued due to an adverse event after completing 12 weeks.



  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
Placebo BIW/Etanercept 50 mg BIW Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
Etanercept 50 mg BIW/Etanercept 50 mg QW Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
Total Total of all reporting groups

Baseline Measures
    Placebo BIW/Etanercept 50 mg BIW     Etanercept 50 mg BIW/Etanercept 50 mg QW     Total  
Number of Participants  
[units: participants]
  62     62     124  
Age  
[units: years]
Mean ± Standard Deviation
  42.68  ± 13.79     41.55  ± 13.93     42.11  ± 13.81  
Gender  
[units: Participants]
     
Female     26     29     55  
Male     36     33     69  
Race/Ethnicity, Customized  
[units: Participants]
     
White or Caucasian     47     43     90  
Black or African American     6     5     11  
Hispanic or Latino     6     8     14  
Asian     2     3     5  
American Indian or Alaska Native     0     1     1  
Aborigine     0     1     1  
Other     1     1     2  
Body Mass Index Group  
[units: participants]
     
≤ 35 kg/m^2     46     44     90  
> 35 kg/m^2     16     18     34  



  Outcome Measures
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1.  Primary:   Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Percentage of Participants With PSSI 75% Response at Week 12   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:   Patient Satisfaction With Treatment at Week 12   [ Time Frame: 12 Weeks ]


  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
No text entered.


  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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


No publications provided


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00791765     History of Changes
Other Study ID Numbers: 20080014
Study First Received: November 14, 2008
Results First Received: September 3, 2010
Last Updated: July 14, 2014
Health Authority: Canada: Institutional Review Board
United States: Food and Drug Administration
United States: Institutional Review Board