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Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

This study has been completed.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01320293
First received: March 18, 2011
Last updated: October 27, 2016
Last verified: October 2016
Results First Received: July 8, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Psoriasis
Intervention: Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]

  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
No text entered.

Reporting Groups
  Description
Adalimumab

active

Adalimumab: 40mg subcutaneously, every other week for 6 months


Participant Flow:   Overall Study
    Adalimumab
STARTED   18 
COMPLETED   16 
NOT COMPLETED   2 
Lack of Efficacy                1 
Adverse Event                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.
No text entered.

Reporting Groups
  Description
Adalimumab

active

Adalimumab: 40mg subcutaneously, every other week for 6 months


Baseline Measures
   Adalimumab 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      18 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 39 
 (19 to 52) 
Gender 
[Units: Participants]
Count of Participants
 
Female      6  33.3% 
Male      12  66.7% 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Change in Endothelial Function Compared to Baseline.   [ Time Frame: 6 months ]

2.  Secondary:   Changes in IL-6 Profile Compared to Baseline   [ Time Frame: 6 months ]

3.  Secondary:   Changes in Adiponectin Profile Compared to Baseline   [ Time Frame: 24 weeks ]


  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
Smaller number of subjects analyzed due to low enrollment. Technical problems with Elisa measurement leading to unreliable or uninterpretable data.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aida Lugo-Somolinos MD
Organization: University of North Carolina
phone: 919-843-9447
e-mail: alugosom@med.unc.edu



Responsible Party: Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01320293     History of Changes
Other Study ID Numbers: ABBO-0001
Study First Received: March 18, 2011
Results First Received: July 8, 2016
Last Updated: October 27, 2016