Trial Outcomes & Findings for Vascular Inflammation in Psoriasis Trial (The VIP Trial) (NCT NCT01553058)
NCT ID: NCT01553058
Last Updated: 2018-05-22
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
97 participants
Primary outcome timeframe
Baseline - Week 12
Results posted on
2018-05-22
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
31
|
33
|
|
Overall Study
COMPLETED
|
32
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vascular Inflammation in Psoriasis Trial (The VIP Trial)
Baseline characteristics by cohort
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.15 years
STANDARD_DEVIATION 13.97 • n=5 Participants
|
44.32 years
STANDARD_DEVIATION 14.50 • n=7 Participants
|
41.97 years
STANDARD_DEVIATION 13.97 • n=5 Participants
|
43.46 years
STANDARD_DEVIATION 14.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Psoriasis Duration
|
14.94 years
STANDARD_DEVIATION 14.73 • n=5 Participants
|
19.29 years
STANDARD_DEVIATION 13.59 • n=7 Participants
|
15.87 years
STANDARD_DEVIATION 13.55 • n=5 Participants
|
16.7 years
STANDARD_DEVIATION 13.94 • n=4 Participants
|
|
Psoriatic Arthritis
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Body Mass Index
|
30.93 kg/m^2
STANDARD_DEVIATION 7.42 • n=5 Participants
|
31.95 kg/m^2
STANDARD_DEVIATION 7.74 • n=7 Participants
|
32.61 kg/m^2
STANDARD_DEVIATION 8.66 • n=5 Participants
|
31.83 kg/m^2
STANDARD_DEVIATION 7.91 • n=4 Participants
|
|
History of Cardiovascular Disease
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Diabetes
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Hypertension
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Hyperlipidemia
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Statin Use
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
10year Framingham Risk %
|
8.43 percentage
STANDARD_DEVIATION 7.75 • n=5 Participants
|
7.91 percentage
STANDARD_DEVIATION 8.83 • n=7 Participants
|
6.12 percentage
STANDARD_DEVIATION 7.68 • n=5 Participants
|
7.53 percentage
STANDARD_DEVIATION 8.09 • n=4 Participants
|
|
Body Surface Area
|
23.39 percentage
STANDARD_DEVIATION 14.48 • n=5 Participants
|
25.70 percentage
STANDARD_DEVIATION 15.02 • n=7 Participants
|
22.96 percentage
STANDARD_DEVIATION 13.37 • n=5 Participants
|
23.98 percentage
STANDARD_DEVIATION 14.19 • n=4 Participants
|
|
PASI (Psoriasis Area and Severity Index)
|
18.89 units on a scale
STANDARD_DEVIATION 5.59 • n=5 Participants
|
18.33 units on a scale
STANDARD_DEVIATION 7.64 • n=7 Participants
|
19.32 units on a scale
STANDARD_DEVIATION 8 • n=5 Participants
|
18.85 units on a scale
STANDARD_DEVIATION 7.08 • n=4 Participants
|
|
PGA (Physician's Global Assessment)
|
3.36 units on a scale
STANDARD_DEVIATION .56 • n=5 Participants
|
3.22 units on a scale
STANDARD_DEVIATION .59 • n=7 Participants
|
3.27 units on a scale
STANDARD_DEVIATION .66 • n=5 Participants
|
3.28 units on a scale
STANDARD_DEVIATION .6 • n=4 Participants
|
|
DLQI (Dermatology Quality of Life Index)
|
15.88 units on a scale
STANDARD_DEVIATION 5.53 • n=5 Participants
|
13.48 units on a scale
STANDARD_DEVIATION 7.58 • n=7 Participants
|
14.61 units on a scale
STANDARD_DEVIATION 6.52 • n=5 Participants
|
14.68 units on a scale
STANDARD_DEVIATION 6.58 • n=4 Participants
|
|
History of Phototherapy
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
H/O Oral Systemics
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
H/O Biologics
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline - Week 12Change 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).
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Vascular Inflammation
|
-.067 Tissue-to-background ratio (TBR)
Standard Deviation .213
|
-.052 Tissue-to-background ratio (TBR)
Standard Deviation .112
|
-.079 Tissue-to-background ratio (TBR)
Standard Deviation .020
|
PRIMARY outcome
Timeframe: Baseline - Week 12To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on total cholesterol.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: Total Cholesterol
|
1.48 mg/dL
Standard Deviation 21.25
|
5.00 mg/dL
Standard Deviation 25.22
|
3.15 mg/dL
Standard Deviation 32.81
|
PRIMARY outcome
Timeframe: Baseline - Week 12To 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.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: Cholesterol Efflux
|
0.05 unitless
Standard Deviation 0.25
|
0.00 unitless
Standard Deviation 0.15
|
0.04 unitless
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: Baseline - Week 12To 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.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total
|
-25.70 nmol/L
Standard Deviation 263.32
|
-34.90 nmol/L
Standard Deviation 319.42
|
17.42 nmol/L
Standard Deviation 187.63
|
PRIMARY outcome
Timeframe: Baseline - Week 12To 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.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total
|
0.59 umol/L
Standard Deviation 4.00
|
-1.97 umol/L
Standard Deviation 7.03
|
1.35 umol/L
Standard Deviation 5.06
|
PRIMARY outcome
Timeframe: Baseline - Week 12To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log insulin.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: Log Insulin
|
-0.19 log(pg/mL)
Standard Deviation 0.71
|
-0.21 log(pg/mL)
Standard Deviation 0.74
|
-0.13 log(pg/mL)
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: Baseline - Week 12To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log adiponectin.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: Log Adiponectin
|
-0.07 log(ug/mL)
Standard Deviation 2.05
|
0.07 log(ug/mL)
Standard Deviation 0.45
|
-0.08 log(ug/mL)
Standard Deviation .41
|
PRIMARY outcome
Timeframe: Baseline - Week 12To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log leptin.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: Log Leptin
|
-0.06 log(pg/mL)
Standard Deviation 0.55
|
0.03 log(pg/mL)
Standard Deviation 0.47
|
0.08 log(pg/mL)
Standard Deviation 0.42
|
PRIMARY outcome
Timeframe: Baseline - Week 12To 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).
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: Log C-reactive Protein
|
-0.52 log(pg/mL)
Standard Deviation 1.00
|
0.35 log(pg/mL)
Standard Deviation 1.06
|
-0.50 log(pg/mL)
Standard Deviation 1.14
|
PRIMARY outcome
Timeframe: Baseline - Week 12To 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.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha
|
-0.27 log(pg/mL)
Standard Deviation 0.33
|
0.14 log(pg/mL)
Standard Deviation 0.38
|
-0.04 log(pg/mL)
Standard Deviation 0.36
|
PRIMARY outcome
Timeframe: Baseline - Week 12To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log interleukin 6.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: Log Interleukin 6
|
-0.57 log(pg/mL)
Standard Deviation 1.08
|
0.20 log(pg/mL)
Standard Deviation 0.99
|
-0.49 log(pg/mL)
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: Baseline - Week 12To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on GlycA
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Cardiometabolic Biomarkers: GlycA
|
-35.89 log(pg/mL)
Standard Deviation 40.38
|
5.28 log(pg/mL)
Standard Deviation 66.83
|
-1.92 log(pg/mL)
Standard Deviation 52.89
|
SECONDARY outcome
Timeframe: Baseline - Week 12Psoriasis activity will be assessed using standard psoriasis measurements, PASI75 and PGA Clear/Almost Clear
Outcome measures
| Measure |
Adalimumab (Humira)
n=32 Participants
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
n=30 Participants
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
n=30 Participants
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.
|
|---|---|---|---|
|
Change in Psoriasis Activity (PASI-75 and PGA)
PASI75
|
15 Participants
|
2 Participants
|
14 Participants
|
|
Change in Psoriasis Activity (PASI-75 and PGA)
PGA Clear/Almost Clear
|
14 Participants
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline -Week 12EQ-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.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Patient-reported Outcomes-EuroQol EQ-5D
|
.07 units on a scale
Standard Deviation .14
|
.0 units on a scale
Standard Deviation .17
|
.16 units on a scale
Standard Deviation .19
|
SECONDARY outcome
Timeframe: Baseline - Week 12Patient 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.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Patient-reported Outcomes-Dermatology Life Quality Index (DLQI)
|
-7.91 units on a scale
Standard Deviation 8.77
|
-3.73 units on a scale
Standard Deviation 8
|
-9.27 units on a scale
Standard Deviation 4.70
|
SECONDARY outcome
Timeframe: Baseline to Week 12Patient 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).
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Patient-reported Outcomes-MEDFICTS Dietary Assessment)
|
-10.17 units on a scale
Standard Deviation 17.47
|
-13.66 units on a scale
Standard Deviation 28.59
|
-16.29 units on a scale
Standard Deviation 20.94
|
SECONDARY outcome
Timeframe: Baseline week 4, 8 and 12Patient 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.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Change in Patient-reported Outcomes-International Physical Activity Questionnaire (IPAQ)
|
1282 MET-minutes/week
Standard Deviation 4837
|
141 MET-minutes/week
Standard Deviation 2921
|
18 MET-minutes/week
Standard Deviation 2994
|
SECONDARY outcome
Timeframe: Baseline - Week 12Safety 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.
Outcome measures
| Measure |
Adalimumab (Humira)
n=33 Participants
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
n=31 Participants
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
n=33 Participants
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.
|
|---|---|---|---|
|
Number of Patients With Adverse Events.
erythema
|
0 Participants
|
0 Participants
|
14 Participants
|
|
Number of Patients With Adverse Events.
pruritis
|
0 Participants
|
0 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events.
photosensitivity
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events.
upper respiratory infection
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events.
nasal congestion
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events.
cough
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events.
sore throat
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events.
headache
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events.
myalgia
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events.
joint range of motion decrease
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events.
depression
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events.
tooth infection
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Adalimumab (Humira)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Injection
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
NB-UVB Phototherapy
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab (Humira)
n=33 participants at risk
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
n=31 participants at risk
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
n=33 participants at risk
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.
|
|---|---|---|---|
|
General disorders
vasovagal syncope
|
6.1%
2/33 • Number of events 2 • Baseline - Week 12
|
0.00%
0/31 • Baseline - Week 12
|
0.00%
0/33 • Baseline - Week 12
|
Other adverse events
| Measure |
Adalimumab (Humira)
n=33 participants at risk
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
n=31 participants at risk
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
n=33 participants at risk
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
pruritis
|
0.00%
0/33 • Baseline - Week 12
|
0.00%
0/31 • Baseline - Week 12
|
18.2%
6/33 • Number of events 6 • Baseline - Week 12
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.00%
0/33 • Baseline - Week 12
|
0.00%
0/31 • Baseline - Week 12
|
42.4%
14/33 • Number of events 14 • Baseline - Week 12
|
|
Skin and subcutaneous tissue disorders
photosensitivity
|
0.00%
0/33 • Baseline - Week 12
|
0.00%
0/31 • Baseline - Week 12
|
9.1%
3/33 • Number of events 3 • Baseline - Week 12
|
|
Infections and infestations
upper respiratory infection
|
9.1%
3/33 • Number of events 3 • Baseline - Week 12
|
12.9%
4/31 • Number of events 4 • Baseline - Week 12
|
6.1%
2/33 • Number of events 2 • Baseline - Week 12
|
|
General disorders
nasal congestion
|
3.0%
1/33 • Number of events 1 • Baseline - Week 12
|
3.2%
1/31 • Number of events 1 • Baseline - Week 12
|
6.1%
2/33 • Number of events 2 • Baseline - Week 12
|
|
General disorders
cough
|
0.00%
0/33 • Baseline - Week 12
|
6.5%
2/31 • Number of events 2 • Baseline - Week 12
|
0.00%
0/33 • Baseline - Week 12
|
|
General disorders
sore throat
|
0.00%
0/33 • Baseline - Week 12
|
6.5%
2/31 • Number of events 2 • Baseline - Week 12
|
3.0%
1/33 • Number of events 1 • Baseline - Week 12
|
|
General disorders
headache
|
3.0%
1/33 • Number of events 1 • Baseline - Week 12
|
6.5%
2/31 • Number of events 2 • Baseline - Week 12
|
6.1%
2/33 • Number of events 2 • Baseline - Week 12
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/33 • Baseline - Week 12
|
6.5%
2/31 • Number of events 2 • Baseline - Week 12
|
3.0%
1/33 • Number of events 1 • Baseline - Week 12
|
|
Musculoskeletal and connective tissue disorders
joint range of motion decrease
|
6.1%
2/33 • Number of events 2 • Baseline - Week 12
|
0.00%
0/31 • Baseline - Week 12
|
0.00%
0/33 • Baseline - Week 12
|
|
Psychiatric disorders
depression
|
0.00%
0/33 • Baseline - Week 12
|
0.00%
0/31 • Baseline - Week 12
|
6.1%
2/33 • Number of events 2 • Baseline - Week 12
|
|
Infections and infestations
tooth infection
|
0.00%
0/33 • Baseline - Week 12
|
6.5%
2/31 • Number of events 2 • Baseline - Week 12
|
0.00%
0/33 • Baseline - Week 12
|
Additional Information
Suzette Baez VanderBeek, MPH
University of Pennsylvania
Phone: 215-662-3514
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place