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

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ClinicalTrials.gov Identifier: NCT01328366

Recruitment Status : Completed

First Posted : April 4, 2011

Results First Posted : June 11, 2015

Last Update Posted : July 9, 2015

Sponsor:

Collaborator:

pH Associates

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

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
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

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1. Primary:

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

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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 ]

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3. Secondary:

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

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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 ]

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5. Secondary:

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

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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 ]

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7. Secondary:

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

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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 ]

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9. Secondary:

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

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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 ]

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11. Secondary:

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

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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 ]

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13. Secondary:

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

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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 ]

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15. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

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
First Submitted:	April 1, 2011
First Posted:	April 4, 2011
Results First Submitted:	May 29, 2015
Results First Posted:	June 11, 2015
Last Update Posted:	July 9, 2015

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