Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab (Body Image)

This study has been completed.
Sponsor:
Collaborator:
pH Associates
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01328366
First received: April 1, 2011
Last updated: June 11, 2015
Last verified: June 2015
Results First Received: May 29, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Psoriasis

  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
Participants With Severe Psoriasis The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.

Participant Flow:   Overall Study
    Participants With Severe Psoriasis  
STARTED     153  
COMPLETED     143  
NOT COMPLETED     10  
Death                 1  
Withdrawal by Subject                 2  
Lost to Follow-up                 7  



  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.
The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies. Baseline demographic data was not available for all participants.

Reporting Groups
  Description
Participants With Severe Psoriasis The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.

Baseline Measures
    Participants With Severe Psoriasis  
Number of Participants  
[units: participants]
  138  
Age  
[units: years]
Mean (Standard Deviation)
  24.0  (12.68)  
Gender  
[units: participants]
 
Female     51  
Male     87  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Dermatology Life Quality Index (DLQI) Scores   [ Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

2.  Primary:   Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline   [ Time Frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

3.  Secondary:   Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores   [ Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

4.  Secondary:   Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline   [ Time Frame: 4 weeks, 16 weeks, and 6 months after adalimumab initiation ]

5.  Secondary:   Psoriasis Area and Severity Index (PASI) Scores   [ Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

6.  Secondary:   Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline   [ Time Frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

7.  Secondary:   Hospital Anxiety and Depression Scale (HADS) Scores   [ Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

8.  Secondary:   Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline   [ Time Frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

9.  Secondary:   Cutaneous Body Image Scale (CBI) Scores   [ Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

10.  Secondary:   Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline   [ Time Frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

11.  Secondary:   12-item Short Form Survey (SF-12) Score   [ Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

12.  Secondary:   Change in 12-item Short Form Survey (SF-12) Score From Baseline   [ Time Frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]

13.  Secondary:   Female Sexual Function Index (FSFI) Score   [ Time Frame: Baseline; 16 weeks, and 6 months following adalimumab initiation ]

14.  Secondary:   Mean Change in Female Sexual Function Index (FSFI) Score From Baseline   [ Time Frame: 4 week, 16 weeks, and 6 months following adalimumab initiation ]

15.  Secondary:   International Index of Erectile Function Score   [ Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation ]


  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: Global Medical Information
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01328366     History of Changes
Other Study ID Numbers: P12-627
Study First Received: April 1, 2011
Results First Received: May 29, 2015
Last Updated: June 11, 2015
Health Authority: United Kingdom: Research Ethics Committee