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Vascular Inflammation in Psoriasis Trial (The VIP Trial) (VIP)

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ClinicalTrials.gov Identifier: NCT01553058
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Psoriasis
Cardiovascular Disease
Interventions: Drug: Adalimumab (Humira)
Drug: Placebo Injection
Other: NB-UVB phototherapy

  Participant Flow

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 (Humira)

Injection of the active drug Humira.

Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.

Placebo Injection

Injection of placebo in place of active Humira injection.

Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.

NB-UVB Phototherapy

NB-UVB Phototherapy 3 times per week, no other intervention.

NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.


Participant Flow:   Overall Study
    Adalimumab (Humira)   Placebo Injection   NB-UVB Phototherapy
STARTED   33   31   33 
COMPLETED   32   30   30 
NOT COMPLETED   1   1   3 



  Baseline Characteristics

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 (Humira)

Injection of the active drug Humira.

Adalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.

Placebo Injection

Injection of placebo in place of active Humira injection.

Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.

NB-UVB Phototherapy

NB-UVB Phototherapy 3 times per week, no other intervention.

NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.

Total Total of all reporting groups

Baseline Measures
   Adalimumab (Humira)   Placebo Injection   NB-UVB Phototherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   31   33   97 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.15  (13.97)   44.32  (14.50)   41.97  (13.97)   43.46  (14.03) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      9  27.3%      11  35.5%      10  30.3%      30  30.9% 
Male      24  72.7%      20  64.5%      23  69.7%      67  69.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      5  15.2%      3   9.7%      7  21.2%      15  15.5% 
Not Hispanic or Latino      27  81.8%      28  90.3%      26  78.8%      81  83.5% 
Unknown or Not Reported      1   3.0%      0   0.0%      0   0.0%      1   1.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      1   3.2%      0   0.0%      1   1.0% 
Asian      1   3.0%      2   6.5%      2   6.1%      5   5.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   9.1%      3   9.7%      3   9.1%      9   9.3% 
White      27  81.8%      24  77.4%      26  78.8%      77  79.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2   6.1%      1   3.2%      2   6.1%      5   5.2% 
Psoriasis Duration 
[Units: Years]
Mean (Standard Deviation)
 14.94  (14.73)   19.29  (13.59)   15.87  (13.55)   16.7  (13.94) 
Psoriatic Arthritis 
[Units: Participants]
Count of Participants
 4   2   3   9 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.93  (7.42)   31.95  (7.74)   32.61  (8.66)   31.83  (7.91) 
History of Cardiovascular Disease 
[Units: Participants]
Count of Participants
 2   3   2   7 
Diabetes 
[Units: Participants]
Count of Participants
 3   1   0   4 
Hypertension 
[Units: Participants]
Count of Participants
 6   7   5   18 
Hyperlipidemia 
[Units: Participants]
Count of Participants
 5   5   4   14 
Statin Use 
[Units: Participants]
Count of Participants
 1   4   3   8 
10year Framingham Risk % [1] 
[Units: Percentage]
Mean (Standard Deviation)
 8.43  (7.75)   7.91  (8.83)   6.12  (7.68)   7.53  (8.09) 
[1] Absolute risk of developing a first cardiovascular disease (CVD) event (coronary death, myocardial infarction, coronary insufficiency, angina, ischemic stroke, hemorrhagic stroke, transient ischemic attack, peripheral artery disease, heart failure) within 10 years. The units are in 10-year risk percentage.
Body Surface Area [1] 
[Units: Percentage]
Mean (Standard Deviation)
 23.39  (14.48)   25.70  (15.02)   22.96  (13.37)   23.98  (14.19) 
[1]

Body Surface Area (BSA) is defined by how much (percentage) of the total body surface area is affected:

Mild psoriasis: <5% of BSA Moderate psoriasis: 5-10% of BSA Severe psoriasis: >10% of BSA (Note: 1% of BSA is approximately equal to the palm of the patient’s hand, excluding fingers)

PASI (Psoriasis Area and Severity Index) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 18.89  (5.59)   18.33  (7.64)   19.32  (8)   18.85  (7.08) 
[1] PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
PGA (Physician's Global Assessment) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.36  (.56)   3.22  (.59)   3.27  (.66)   3.28  (.6) 
[1] The PGA is an average assessment of all psoriatic lesions based on erythema, scale, and induration with score ranging from 0 (no evidence of disease) to 5 (maximal disease).
DLQI (Dermatology Quality of Life Index) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 15.88  (5.53)   13.48  (7.58)   14.61  (6.52)   14.68  (6.58) 
[1] The DLQI is calculated by summing the score of 10 questions regarding impact of skin condition on daily life resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
History of Phototherapy 
[Units: Participants]
Count of Participants
 5   11   13   29 
H/O Oral Systemics 
[Units: Participants]
Count of Participants
 10   10   11   31 
H/O Biologics 
[Units: Participants]
Count of Participants
 10   11   8   29 


  Outcome Measures

1.  Primary:   Change in Vascular Inflammation   [ Time Frame: Baseline - Week 12 ]

2.  Primary:   Change in Cardiometabolic Biomarkers: Total Cholesterol   [ Time Frame: Baseline - Week 12 ]

3.  Primary:   Change in Cardiometabolic Biomarkers: Cholesterol Efflux   [ Time Frame: Baseline - Week 12 ]

4.  Primary:   Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total   [ Time Frame: Baseline - Week 12 ]

5.  Primary:   Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total   [ Time Frame: Baseline - Week 12 ]

6.  Primary:   Change in Cardiometabolic Biomarkers: Log Insulin   [ Time Frame: Baseline - Week 12 ]

7.  Primary:   Change in Cardiometabolic Biomarkers: Log Adiponectin   [ Time Frame: Baseline - Week 12 ]

8.  Primary:   Change in Cardiometabolic Biomarkers: Log Leptin   [ Time Frame: Baseline - Week 12 ]

9.  Primary:   Change in Cardiometabolic Biomarkers: Log C-reactive Protein   [ Time Frame: Baseline - Week 12 ]

10.  Primary:   Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha   [ Time Frame: Baseline - Week 12 ]

11.  Primary:   Change in Cardiometabolic Biomarkers: Log Interleukin 6   [ Time Frame: Baseline - Week 12 ]

12.  Primary:   Change in Cardiometabolic Biomarkers: GlycA   [ Time Frame: Baseline - Week 12 ]

13.  Secondary:   Change in Psoriasis Activity (PASI-75 and PGA)   [ Time Frame: Baseline - Week 12 ]

14.  Secondary:   Change in Patient-reported Outcomes-EuroQol EQ-5D   [ Time Frame: Baseline -Week 12 ]

15.  Secondary:   Change in Patient-reported Outcomes-Dermatology Life Quality Index (DLQI)   [ Time Frame: Baseline - Week 12 ]

16.  Secondary:   Change in Patient-reported Outcomes-MEDFICTS Dietary Assessment)   [ Time Frame: Baseline to Week 12 ]

17.  Secondary:   Change in Patient-reported Outcomes-International Physical Activity Questionnaire (IPAQ)   [ Time Frame: Baseline week 4, 8 and 12 ]

18.  Secondary:   Number of Patients With Adverse Events.   [ Time Frame: Baseline - Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Suzette Baez VanderBeek, MPH
Organization: University of Pennsylvania
phone: 215-662-3514
e-mail: suzettev@upenn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01553058     History of Changes
Other Study ID Numbers: 814278
First Submitted: February 14, 2012
First Posted: March 13, 2012
Results First Submitted: August 4, 2017
Results First Posted: May 22, 2018
Last Update Posted: May 22, 2018