This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
History of Changes
Results First Received: May 29, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Psoriasis

  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
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
  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.
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 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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

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 ]
  Show Outcome Measure 4

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

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 ]
  Show Outcome Measure 6

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

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 ]
  Show Outcome Measure 8

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

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 ]
  Show Outcome Measure 10

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

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 ]
  Show Outcome Measure 12

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

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 ]
  Show Outcome Measure 14

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show 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 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



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