Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01077128
First received: February 25, 2010
Last updated: February 19, 2014
Last verified: February 2014
Results First Received: September 13, 2013  
Study Type: Observational
Study Design: 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
Patients With Psoriasis All eligible patients with psoriasis treated with Adalimumab

Participant Flow:   Overall Study
    Patients With Psoriasis  
STARTED     500  
COMPLETED     433  
NOT COMPLETED     67  
Adverse Event                 8  
Lack of Efficacy                 1  
Disease exacerbation                 1  
Adverse event and consent withdrawal                 1  
Adverse event and disease exacerbation                 1  
Lack of efficacy/disease exacerbation                 1  
Not available                 54  



  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.
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Reporting Groups
  Description
Patients With Psoriasis All eligible patients with psoriasis treated with Adalimumab

Baseline Measures
    Patients With Psoriasis  
Number of Participants  
[units: participants]
  500  
Age, Customized  
[units: participants]
 
>=18 years     500  
Gender  
[units: participants]
 
Female     190  
Male     310  
Region of Enrollment  
[units: participants]
 
Greece     500  
Regions of Greece  
[units: Participants]
 
Attica     266  
Central Macedonia     71  
Crete     41  
West Greece     33  
East Macedonia and Thrace     20  
Thessaly     18  
Central Greece     16  
Peloponnese     16  
North Aegean     8  
Ionian Islands     4  
West Macedonia     3  
South Aegean     2  
Epirus     2  



  Outcome Measures
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1.  Primary:   Mean Change of Dermatology Life Quality Index (DLQI) Scores   [ Time Frame: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12) ]

2.  Secondary:   Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician’s Global Assessment of Disease Severity (PGA) Scores   [ Time Frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12) ]

3.  Secondary:   Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician’s Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region   [ Time Frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12) ]

4.  Secondary:   Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)   [ Time Frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12) ]

5.  Secondary:   Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores   [ Time Frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12) ]

6.  Secondary:   Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization   [ Time Frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12) ]


  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 Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01077128     History of Changes
Other Study ID Numbers: P11-984
Study First Received: February 25, 2010
Results First Received: September 13, 2013
Last Updated: February 19, 2014
Health Authority: Greece: National Organization of Medicines