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Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities (EPIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401452
First Posted: July 25, 2011
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
Results First Submitted: May 12, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Moderate to Severe Plaque 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
No text entered.

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 Psoriasis and at Least One Co-morbid Disease Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression

Participant Flow:   Overall Study
    Participants With Psoriasis and at Least One Co-morbid Disease
STARTED   246 
Visit 1 (Baseline)   246 
Visit 2 (1 Month)   225 
Visit 3 (3 Months)   217 
Visit 4 (6 Months)   172 
Visit 5 (9 Months)   175 
COMPLETED   174 
NOT COMPLETED   72 
Adverse reaction                9 
Lost to Follow-up                12 
Lack of Efficacy                30 
Participant developed breast cancer                1 
Tx stopped due to financial reasons                1 
Tx stopped by psychiatrist                1 
No more visits within the 36 wk followup                4 
Subject did not come to follow up visits                2 
Subject didn't return for routine visits                1 
Subject moved to another city                1 
Subject's wife wants to get pregnant                1 
Psoriatic arthritis                1 
Participant stopped Tx                2 
Discontinuation for personal reasons                1 
Treatment failure                1 
Unsatisfactory output                1 
Subject withdrew because of Tx success                1 
Subject chose to discontinue treatment                1 
Participant withdrew consent                1 



  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
Participants With Psoriasis and at Least One Co-morbid Disease Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression

Baseline Measures
   Participants With Psoriasis and at Least One Co-morbid Disease 
Overall Participants Analyzed 
[Units: Participants]
 246 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 246 
   48.8  (13.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 246 
Female      93  37.8% 
Male      153  62.2% 
Duration of psoriasis 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 246 
   18.6  (13.6) 
Number of participants with comorbidities [1] 
[Units: Participants]
 
Female   
Participants Analyzed 
[Units: Participants]
 93 
Female   93 
Male   
Participants Analyzed 
[Units: Participants]
 153 
Male   152 
[1] Males and females were analyzed separately
Most prevalent co-morbidities among participants in the study 
[Units: Participants]
 
Psoriatic arthritis   
Participants Analyzed 
[Units: Participants]
 246 
Psoriatic arthritis   114 
Hypertension   
Participants Analyzed 
[Units: Participants]
 246 
Hypertension   79 
Metabolic syndrome   
Participants Analyzed 
[Units: Participants]
 246 
Metabolic syndrome   72 
Obesity   
Participants Analyzed 
[Units: Participants]
 246 
Obesity   64 
Diabetes   
Participants Analyzed 
[Units: Participants]
 246 
Diabetes   31 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9   [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]

2.  Secondary:   Mean Dermatology Life Quality Index (DLQI) Scores   [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]

3.  Secondary:   Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9   [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]

4.  Secondary:   Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9   [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]

5.  Secondary:   Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9   [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]

6.  Secondary:   Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months   [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]

7.  Secondary:   Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months   [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]

8.  Secondary:   Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months   [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]

9.  Secondary:   Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months   [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]


  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



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01401452     History of Changes
Other Study ID Numbers: P12-770
First Submitted: July 1, 2011
First Posted: July 25, 2011
Results First Submitted: May 12, 2017
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017