Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs (QUALITY)

This study has been completed.

Sponsor:

Collaborator:

Assign data management and biostatistics Gmbh

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT01084668

First received: February 28, 2010

Last updated: June 25, 2012

Last verified: June 2012

History of Changes

Results First Received: April 26, 2012

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Psoriasis Chronic

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
A total of 46 participants were screened for this PMOS at 9 study sites in Austria. One participant did not meet entry criteria (screening failure), and 45 participants were enrolled and received treatment with adalimumab in the study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three participants were excluded from the database because they had been treated with adalimumab prior to their Visit 1. Statistical analysis has been performed for the 42 participants included in the All Treated population.

Reporting Groups

	Description
Adalimumab	Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure

Participant Flow: Overall Study

	Adalimumab
STARTED	42 ^[1]
COMPLETED	33
NOT COMPLETED	9
Lack of Efficacy	5
Withdrawal by Subject	2
Pregnancy	1
Non-compliance	1

[1]	Three participants who took Humira prior to study entry have been excluded from the database.

Baseline Characteristics

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Reporting Groups

	Description
Adalimumab	Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure

Baseline Measures

	Adalimumab
Number of Participants [units: participants]	42
Age [units: years] Mean ± Standard Deviation	47.1 ± 11.5
Gender [units: participants]
Female	15
Male	27
Region of Enrollment [units: participants]
Austria	42

Outcome Measures

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1. Primary:

Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52 ]

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2. Primary:

Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75) [ Time Frame: Inclusion visit (Week 0) to Week 52 ]

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3. Secondary:

Dermatology Life Quality Index (DLQI) Score [ Time Frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52 ]

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Measure Type	Secondary
Measure Title	Dermatology Life Quality Index (DLQI) Score
Measure Description	Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).
Time Frame	Inclusion visit (Week 0), Week 4, Week 36, Week 52
Safety Issue	No

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.
Analysis was performed on the All Treated population using an observed case approach. DLQI score was assessed at Weeks 0, 4, 36, and 52 in 36, 34, 26, and 27 participants, respectively.

Reporting Groups

	Description
All Treated	Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure

Measured Values

	All Treated
Number of Participants Analyzed [units: participants]	42
Dermatology Life Quality Index (DLQI) Score [units: units on a scale] Mean ± Standard Deviation
Week 0	13.8 ± 8.3
Week 4	7.2 ± 5.6
Week 36	2.2 ± 3.4
Week 52	2.2 ± 4.8

No statistical analysis provided for Dermatology Life Quality Index (DLQI) Score

4. Secondary:

Nail Psoriasis Severity Index (NAPSI) Score [ Time Frame: Inclusion visit (Week 0), Week 4, Week 36, and Week 52 ]

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5. Secondary:

Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions [ Time Frame: From the time of participant consent until 70 days after last dose of study drug ]

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Serious Adverse Events

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Other Adverse Events

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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: Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.

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.

Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01084668 History of Changes
Other Study ID Numbers:	P10-708
Study First Received:	February 28, 2010
Results First Received:	April 26, 2012
Last Updated:	June 25, 2012
Health Authority:	Austria: Federal Office for Safety in Health Care

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