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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
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description

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.

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 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.

Period Title: Overall Study
Started 33 31 33
Completed 32 30 30
Not Completed 1 1 3
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy Total
Hide Arm/Group Description

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.

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 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 of all reporting groups
Overall Number of Baseline Participants 33 31 33 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 31 participants 33 participants 97 participants
44.15  (13.97) 44.32  (14.50) 41.97  (13.97) 43.46  (14.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 31 participants 33 participants 97 participants
14.94  (14.73) 19.29  (13.59) 15.87  (13.55) 16.7  (13.94)
Psoriatic Arthritis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 participants
4
  12.1%
2
   6.5%
3
   9.1%
9
   9.3%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 33 participants 31 participants 33 participants 97 participants
30.93  (7.42) 31.95  (7.74) 32.61  (8.66) 31.83  (7.91)
History of Cardiovascular Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 participants
2
   6.1%
3
   9.7%
2
   6.1%
7
   7.2%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 participants
3
   9.1%
1
   3.2%
0
   0.0%
4
   4.1%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 participants
6
  18.2%
7
  22.6%
5
  15.2%
18
  18.6%
Hyperlipidemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 participants
5
  15.2%
5
  16.1%
4
  12.1%
14
  14.4%
Statin Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 participants
1
   3.0%
4
  12.9%
3
   9.1%
8
   8.2%
10year Framingham Risk %   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 33 participants 31 participants 33 participants 97 participants
8.43  (7.75) 7.91  (8.83) 6.12  (7.68) 7.53  (8.09)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 33 participants 31 participants 33 participants 97 participants
23.39  (14.48) 25.70  (15.02) 22.96  (13.37) 23.98  (14.19)
[1]
Measure Description:

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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 31 participants 33 participants 97 participants
18.89  (5.59) 18.33  (7.64) 19.32  (8) 18.85  (7.08)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 31 participants 33 participants 97 participants
3.36  (.56) 3.22  (.59) 3.27  (.66) 3.28  (.6)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 31 participants 33 participants 97 participants
15.88  (5.53) 13.48  (7.58) 14.61  (6.52) 14.68  (6.58)
[1]
Measure Description: 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 participants
5
  15.2%
11
  35.5%
13
  39.4%
29
  29.9%
H/O Oral Systemics  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 participants
10
  30.3%
10
  32.3%
11
  33.3%
31
  32.0%
H/O Biologics  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 33 participants 97 participants
10
  30.3%
11
  35.5%
8
  24.2%
29
  29.9%
1.Primary Outcome
Title Change in Vascular Inflammation
Hide Description Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12. The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:

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.

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 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.

Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: Tissue-to-background ratio (TBR)
-.067  (.213) -.052  (.112) -.079  (.020)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of Differences
Statistical Test of Hypothesis P-Value 0.795
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.647
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
2.Primary Outcome
Title Change in Cardiometabolic Biomarkers: Total Cholesterol
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on total cholesterol.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.48  (21.25) 5.00  (25.22) 3.15  (32.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.386
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of Differences
Statistical Test of Hypothesis P-Value 0.280
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
3.Primary Outcome
Title Change in Cardiometabolic Biomarkers: Cholesterol Efflux
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on cholesterol efflux capacity. The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)]. The pooled plasma was obtained from five healthy volunteers.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: unitless
0.05  (0.25) 0.00  (0.15) 0.04  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of Differences
Statistical Test of Hypothesis P-Value 0.357
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of Differences
Statistical Test of Hypothesis P-Value 0.496
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
4.Primary Outcome
Title Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on low density lipoprotein particle total.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
njection 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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: nmol/L
-25.70  (263.32) -34.90  (319.42) 17.42  (187.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of Differences
Statistical Test of Hypothesis P-Value 0.897
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.467
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
5.Primary Outcome
Title Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on high density lipoprotein particle total.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: umol/L
0.59  (4.00) -1.97  (7.03) 1.35  (5.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
6.Primary Outcome
Title Change in Cardiometabolic Biomarkers: Log Insulin
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log insulin.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: log(pg/mL)
-0.19  (0.71) -0.21  (0.74) -0.13  (0.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.934
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.679
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
7.Primary Outcome
Title Change in Cardiometabolic Biomarkers: Log Adiponectin
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log adiponectin.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: log(ug/mL)
-0.07  (2.05) 0.07  (0.45) -0.08  (.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.672
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.655
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
8.Primary Outcome
Title Change in Cardiometabolic Biomarkers: Log Leptin
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log leptin.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: log(pg/mL)
-0.06  (0.55) 0.03  (0.47) 0.08  (0.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.504
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.695
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
9.Primary Outcome
Title Change in Cardiometabolic Biomarkers: Log C-reactive Protein
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log C-reactive protein (CRP).
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: log(pg/mL)
-0.52  (1.00) 0.35  (1.06) -0.50  (1.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
10.Primary Outcome
Title Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log Tumor necrosis factor-alpha.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: log(pg/mL)
-0.27  (0.33) 0.14  (0.38) -0.04  (0.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of Differences
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.065
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
11.Primary Outcome
Title Change in Cardiometabolic Biomarkers: Log Interleukin 6
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log interleukin 6.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: log(pg/mL)
-0.57  (1.08) 0.20  (0.99) -0.49  (1.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
12.Primary Outcome
Title Change in Cardiometabolic Biomarkers: GlycA
Hide Description To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on GlycA
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: log(pg/mL)
-35.89  (40.38) 5.28  (66.83) -1.92  (52.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab (Humira), Placebo Injection
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection, NB-UVB Phototherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference of differences
Statistical Test of Hypothesis P-Value 0.628
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
13.Secondary Outcome
Title Change in Psoriasis Activity (PASI-75 and PGA)
Hide Description Psoriasis activity will be assessed using standard psoriasis measurements, PASI75 and PGA Clear/Almost Clear
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:

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.

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 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.

Overall Number of Participants Analyzed 32 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
PASI75
15
  46.9%
2
   6.7%
14
  46.7%
PGA Clear/Almost Clear
14
  43.8%
2
   6.7%
8
  26.7%
14.Secondary Outcome
Title Change in Patient-reported Outcomes-EuroQol EQ-5D
Hide Description EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale ranging from 1 (no health state problem) to 3 (extreme health state problems). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale ranging from 0, worst health state, to 100, best health state. A scoring function is used to assign a value (i.e., EQ-5D™ index score) to self-reported health states from a set of population-based preference weights. For the U.S. general population, the possible EQ-5D index scores range from -0.11 to 1.0 where 0.0 = death and 1.0 = perfect health.
Time Frame Baseline -Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:

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.

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 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.

Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
.07  (.14) .0  (.17) .16  (.19)
15.Secondary Outcome
Title Change in Patient-reported Outcomes-Dermatology Life Quality Index (DLQI)
Hide Description Patient reported quality of life outcomes will be assessed using DLQI. 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.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:

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.

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 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.

Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.91  (8.77) -3.73  (8) -9.27  (4.70)
16.Secondary Outcome
Title Change in Patient-reported Outcomes-MEDFICTS Dietary Assessment)
Hide Description Patient reported dietary outcomes will be assessed using MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument for properly assessing cardiovascular diet. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of <40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day).
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:

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.

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 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.

Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
-10.17  (17.47) -13.66  (28.59) -16.29  (20.94)
17.Secondary Outcome
Title Change in Patient-reported Outcomes-International Physical Activity Questionnaire (IPAQ)
Hide Description Patient reported physical activity will be assessed using IPAQ. IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.
Time Frame Baseline week 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:

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.

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 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.

Overall Number of Participants Analyzed 33 31 33
Mean (Standard Deviation)
Unit of Measure: MET-minutes/week
1282  (4837) 141  (2921) 18  (2994)
18.Secondary Outcome
Title Number of Patients With Adverse Events.
Hide Description Safety will be assessed by comparing how many patients have adverse events depending on whether they are on adalimumab, as compared to NB-UVB phototherapy or placebo.
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description:

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.

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 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.

Overall Number of Participants Analyzed 33 31 33
Measure Type: Count of Participants
Unit of Measure: Participants
erythema
0
   0.0%
0
   0.0%
14
  42.4%
pruritis
0
   0.0%
0
   0.0%
6
  18.2%
photosensitivity
0
   0.0%
0
   0.0%
3
   9.1%
upper respiratory infection
3
   9.1%
4
  12.9%
2
   6.1%
nasal congestion
1
   3.0%
1
   3.2%
2
   6.1%
cough
0
   0.0%
2
   6.5%
0
   0.0%
sore throat
0
   0.0%
2
   6.5%
1
   3.0%
headache
1
   3.0%
2
   6.5%
2
   6.1%
myalgia
0
   0.0%
2
   6.5%
1
   3.0%
joint range of motion decrease
2
   6.1%
0
   0.0%
0
   0.0%
depression
0
   0.0%
0
   0.0%
2
   6.1%
tooth infection
0
   0.0%
2
   6.5%
0
   0.0%
Time Frame Baseline - Week 12
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Hide Arm/Group Description

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.

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 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.

All-Cause Mortality
Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/33 (6.06%)      0/31 (0.00%)      0/33 (0.00%)    
General disorders       
vasovagal syncope * 1  2/33 (6.06%)  2 0/31 (0.00%)  0 0/33 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adalimumab (Humira) Placebo Injection NB-UVB Phototherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/33 (21.21%)      15/31 (48.39%)      33/33 (100.00%)    
General disorders       
nasal congestion * 1  1/33 (3.03%)  1 1/31 (3.23%)  1 2/33 (6.06%)  2
cough * 1  0/33 (0.00%)  0 2/31 (6.45%)  2 0/33 (0.00%)  0
sore throat * 1  0/33 (0.00%)  0 2/31 (6.45%)  2 1/33 (3.03%)  1
headache * 1  1/33 (3.03%)  1 2/31 (6.45%)  2 2/33 (6.06%)  2
Infections and infestations       
upper respiratory infection * 1  3/33 (9.09%)  3 4/31 (12.90%)  4 2/33 (6.06%)  2
tooth infection * 1  0/33 (0.00%)  0 2/31 (6.45%)  2 0/33 (0.00%)  0
Musculoskeletal and connective tissue disorders       
myalgia * 1  0/33 (0.00%)  0 2/31 (6.45%)  2 1/33 (3.03%)  1
joint range of motion decrease * 1  2/33 (6.06%)  2 0/31 (0.00%)  0 0/33 (0.00%)  0
Psychiatric disorders       
depression * 1  0/33 (0.00%)  0 0/31 (0.00%)  0 2/33 (6.06%)  2
Skin and subcutaneous tissue disorders       
pruritis * 1  0/33 (0.00%)  0/31 (0.00%)  6/33 (18.18%)  6
erythema * 1  0/33 (0.00%)  0/31 (0.00%)  14/33 (42.42%)  14
photosensitivity * 1  0/33 (0.00%)  0 0/31 (0.00%)  0 3/33 (9.09%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Suzette Baez VanderBeek, MPH
Organization: University of Pennsylvania
Phone: 215-662-3514
EMail: suzettev@upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01553058    
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