PsoriasisPhase 4VIPNCT01553058
Vascular Inflammation in Psoriasis Trial (The VIP Trial)
A Phase 4 study testing Adalimumab (Humira) and NB-UVB phototherapy in people with Psoriasis and Cardiovascular Disease, run by University of Pennsylvania at 9 sites in United States.
Trial summary
The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Cardiovascular Disease
- What is being tested?
- Adalimumab (Humira) and NB-UVB phototherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2012to 27 Oct 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18 years of age and older.
- Clinical diagnosis of psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by Investigator.
- Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week 0) as determined by subject interview of his/her medical history.
- Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA) involvement at the Baseline (Week 0) visit.
- PASI (psoriasis assessment and severity index) score of ≥ 12 at the Baseline (Week 0) visit.
- Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite prior treatment with topical agents.
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- Women are eligible to participate in the study if they meet one of the following criteria:
- Women of childbearing potential who are willing to undergo regular pregnancy testing and agree to use one method of contraception throughout the study are eligible to participate
- Women who are postmenopausal (for at least one year), sterile, or hysterectomized are eligible to participate
- Women who have undergone tubal ligation are eligible to participate
- Women who agree to be sexually abstinent, defined as total abstinence from sexual intercourse, as a form of contraception are eligible to participate in the study.
- Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, and 12-lead electrocardiogram (ECG) performed at screening.
- Able and willing to give written informed consent and to comply with requirements of this study protocol.
Who cannot join
- Previous adverse event following exposure to a TNF-alpha antagonist and/or UV phototherapy that led to discontinuation of either of these therapies and contraindicates future treatment.
- Previous lack of response to a TNF-alpha antagonist and/or UV phototherapy that led to discontinuation of either of these therapies.
- Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
- Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
- Cannot avoid UVB phototherapy for at least 14 days prior to the Baseline (Week 0) visit.
- Cannot avoid psoralen-UVA phototherapy for at least 30 days prior to the Baseline (Week 0) visit and during the study.
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- Cannot discontinue systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis, during the study:
- Systemic (investigational or marketed) therapies must be discontinued at least 30 days prior to the Baseline (Week 0) visit except for biologics.
- All biologics, except ustekinumab, must be discontinued for at least 90 days prior to Baseline (Week 0).
- The IL-12/IL-23 antagonist ustekinumab (half-life of 45.6 ± 80.2 days) must be discontinued for at least 180 days prior to Baseline (Week 0).
- Investigational agents must be discontinued at least 30 days or 5 half-lives (whichever is longer) prior to the Baseline (Week 0) visit.
- Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
- Poorly controlled medical condition, such as unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents, psychiatric disease requiring frequent hospitalization, and any other condition, which, in the opinion of the Investigator, would put the subject at risk by participation in the study.
- History of diabetes mellitus, type 1 or type 2 - note that patients with type 2 diabetes may be enrolled if the duration of diabetes is <10 years and HbA1c is <7.0%)
- Uncontrolled hypertension, with measured systolic blood pressure >180 mmHg or diastolic blood pressure >90 mmHg
- History of demyelinating diseases or lupus.
- Subject has infection or risk factors for severe infections, for example:
- Positive serology or known history of HIV, hepatitis B or C, or other severe, recurrent, or persistent infections;
- Excessive immunosuppression or other factors associated with it, including human immunodeficiency virus infection;
- Active tuberculosis (TB) disease;
- Evidence of latent TB infection demonstrated by Purified Protein Derivative (PPD) ≥ 5 mm of induration or positive Quantiferon-GOLD results; except if prophylactic treatment for TB, as recommended by local guidelines, is initiated prior to administration of study drug or if there is documentation that the subject has received prophylactic treatment for TB previously.
- Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the month prior to Baseline;
- Infection requiring treatment with oral or parenteral antibiotics within 14 days prior to Baseline;
- Subject has received vaccination with Bacille Calmette-Guerin (BCG) within 365 days prior to Screening;
- Subject has received vaccination with a live viral agent 30 days prior to Screening or will require a live vaccination during study participation including up to 30 days after the last dose of study drug.
- Subject has history of hematological or solid malignancy other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical carcinoma in situ.
- Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
- Screening clinical laboratory analyses showing any of the following abnormal results:
- Hemoglobin (Hgb) < 10 g/dL in females or <12 g/dL in males;
- White blood cell (WBC) count <2.5 x 109/L
- o Subject can be included if WBC count is <2.5 x x 109/L and absolute neutrophil count (ANC) is >1000 cells / mm3.
- WBC count > 15 x 109/L;
- Platelet count < 100 x 109/L;
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) >2.5 upper limits of normal (ULN);
- Serum total bilirubin ≥2 mg/dL (≥26 µmol/L); or
- Serum creatinine >1.6 mg/dL (>141 µmol/L).
- Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
- History of any substance abuse within 365 days of screening visit
- Alcohol use >14 drinks per week at the screening visit or within 30 days of the screening period
- If subject is on cholesterol-lowering medication (e.g. statin), dose and form of medication must be stable for 90 days prior to week 0 and remain stable throughout the duration of the study.
- History of photosensitivity of medical condition that may be exacerbated by UV exposures such as lupus or dermatomyositis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
National Heart, Lung, and Blood Institute
Bethesda, Maryland, 20892
Buffalo Medical Group
Buffalo, New York, 14221
Menter Dermatology Research Institute
Dallas, Texas, 75246
The University of Colorado
Denver, Colorado, 80045
Center for Clinical Studies
Houston, Texas, 77004
The University of Pennsylvania
Philadelphia, Pennsylvania, 19140
Oregon Health & Science University
Portland, Oregon, 97239
University of California, Davis Health System
Sacramento, California, 95816
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: A Trial to Determine the Effect of Psoriasis Treatment on Cardiometabolic Disease
The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis.
This study will look for systemic vascular inflammation in subjects with a test called FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardio metabolic (heart disease and metabolic factors such as diabetes) identifiers in the blood. A blood sample will be taken that will look for these markers identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation.
This study will also assess the effect of adalimumab (Humira), when compared to NB-UVB phototherapy or placebo injection on psoriasis activity and severity. The study will also compare the safety of adalimumab (Humira) to NB-UVB phototherapy or placebo injection. This study will also evaluate subjects' reported outcomes through a questionnaire that will assess quality-of-life in subjects living with psoriasis.
- Conditions
- Psoriasis, Cardiovascular Disease
- Being tested
- Adalimumab (Humira), Placebo Injection, NB-UVB phototherapy
- Keywords
- Psoriasis, Cardiovascular Disease, FDG/PET-CT, NB-UVB Phototherapy, Vascular Inflammation, Lipid Biomarkers
- Medical subject headings
- Psoriasis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab (Humira)Drug
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 InjectionDrug
Placebo injection will be given according to the same dose and schedule as the active comparator.
NB-UVB phototherapyOther
Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab (Humira) | Active comparator | Injection of the active drug Humira. Receives: Drug: Adalimumab (Humira) |
| Placebo Injection | Placebo comparator | Injection of placebo in place of active Humira injection. Receives: Drug: Placebo Injection |
| NB-UVB phototherapy | Active comparator | NB-UVB Phototherapy 3 times per week, no other intervention. Receives: Other: NB-UVB phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vascular Inflammation
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).
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: Total Cholesterol
To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on total cholesterol.
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: Cholesterol Efflux
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.
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total
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.
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total
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.
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: Log Insulin
To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log insulin.
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: Log Adiponectin
To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log adiponectin.
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: Log Leptin
To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log leptin.
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: Log C-reactive Protein
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).
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha
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.
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: Log Interleukin 6
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.
Measured: Baseline - Week 12
Change in Cardiometabolic Biomarkers: GlycA
To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on GlycA
Measured: Baseline - Week 12
Secondary outcomes (6)
Change in Psoriasis Activity (PASI-75 and PGA)
Psoriasis activity will be assessed using standard psoriasis measurements, PASI75 and PGA Clear/Almost Clear
Measured: Baseline - Week 12
Change in Patient-reported Outcomes-EuroQol EQ-5D
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.
Measured: Baseline -Week 12
Change in Patient-reported Outcomes-Dermatology Life Quality Index (DLQI)
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.
Measured: Baseline - Week 12
Change in Patient-reported Outcomes-MEDFICTS Dietary Assessment)
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).
Measured: Baseline to Week 12
Change in Patient-reported Outcomes-International Physical Activity Questionnaire (IPAQ)
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.
Measured: Baseline week 4, 8 and 12
Number of Patients With Adverse Events.
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.
Measured: Baseline - Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJul 2012
- Primary completion8 Aug 2016
- Study completion27 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Gelfand, MD MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553058
- Sponsor's protocol ID
- 814278
- Acronym
- VIP
- Status last verified
- Apr 2018
- First submitted
- 14 Feb 2012
- Last updated
- 22 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ramessur R, Kernizan F, Ranjbar E, Mehta NN, Alavi A, Shin DB, Iacobellis G, Gelfand JM. Adalimumab Reduces Epicardial Adipose Tissue in Psoriasis: A Post Hoc Analysis of a Randomized Placebo-Controlled Clinical Trial. Psoriasis (Auckl). 2026 Aug 30;16:628498. doi: 10.2147/PTT.S628498. eCollection 2026.
PubMed 42694939Noe MH, Wan MT, Shin DB, Armstrong AW, Duffin KC, Chiesa Fuxench ZC, Kalb RE, Menter A, Simpson EL, Takeshita J, Tyring SK, Van Voorhees AS, Mehta NN, Gelfand JM. Patient-reported outcomes of adalimumab, phototherapy, and placebo in the Vascular Inflammation in Psoriasis Trial: A randomized controlled study. J Am Acad Dermatol. 2019 Oct;81(4):923-930. doi: 10.1016/j.jaad.2019.05.080. Epub 2019 Jun 1.
PubMed 31163241Mehta NN, Shin DB, Joshi AA, Dey AK, Armstrong AW, Duffin KC, Fuxench ZC, Harrington CL, Hubbard RA, Kalb RE, Menter A, Rader DJ, Reilly MP, Simpson EL, Takeshita J, Torigian DA, Werner TJ, Troxel AB, Tyring SK, Vanderbeek SB, Van Voorhees AS, Playford MP, Ahlman MA, Alavi A, Gelfand JM. Effect of 2 Psoriasis Treatments on Vascular Inflammation and Novel Inflammatory Cardiovascular Biomarkers: A Randomized Placebo-Controlled Trial. Circ Cardiovasc Imaging. 2018 Jun;11(6):e007394. doi: 10.1161/CIRCIMAGING.117.007394.
PubMed 29776990
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Determine the Effect of Psoriasis Treatment on Cardiometabolic Disease
- ClinicalTrials.gov ID
- NCT01553058
- Acronym / sponsor ID
- VIP / 814278
- Conditions
- Psoriasis, Cardiovascular Disease
- Keywords
- Psoriasis, Cardiovascular Disease, FDG/PET-CT, NB-UVB Phototherapy, Vascular Inflammation, Lipid Biomarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 8 Aug 2016 (actual)
- Study completion
- 27 Oct 2016 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Posted 22 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis.
This study will look for systemic vascular inflammation in subjects with a test called FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardio metabolic (heart disease and metabolic factors such as diabetes) identifiers in the blood. A blood sample will be taken that will look for these markers identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation.
This study will also assess the effect of adalimumab (Humira), when compared to NB-UVB phototherapy or placebo injection on psoriasis activity and severity. The study will also compare the safety of adalimumab (Humira) to NB-UVB phototherapy or placebo injection. This study will also evaluate subjects' reported outcomes through a questionnaire that will assess quality-of-life in subjects living with psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adalimumab (Humira) | Active comparator | Drug: Adalimumab (Humira)Injection of the active drug Humira. |
| Placebo Injection | Placebo comparator | Drug: Placebo InjectionInjection of placebo in place of active Humira injection. |
| NB-UVB phototherapy | Active comparator | Other: NB-UVB phototherapyNB-UVB Phototherapy 3 times per week, no other intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females 18 years of age and older.
- Clinical diagnosis of psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by Investigator.
- Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week 0) as determined by subject interview of his/her medical history.
- Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA) involvement at the Baseline (Week 0) visit.
- PASI (psoriasis assessment and severity index) score of ≥ 12 at the Baseline (Week 0) visit.
Key exclusion criteria (41 listed)
- Previous adverse event following exposure to a TNF-alpha antagonist and/or UV phototherapy that led to discontinuation of either of these therapies and contraindicates future treatment.
- Previous lack of response to a TNF-alpha antagonist and/or UV phototherapy that led to discontinuation of either of these therapies.
- Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
- Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
- Cannot avoid UVB phototherapy for at least 14 days prior to the Baseline (Week 0) visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Adalimumab (Humira) |
| Placebo InjectionPlacebo injection will be given according to the same dose and schedule as the active comparator. | Drug | Placebo Injection |
| NB-UVB phototherapyPhototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types. | Other | NB-UVB phototherapy |
Primary outcome
Change in Vascular Inflammation
Time frame: Baseline - Week 12
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).
Change in Cardiometabolic Biomarkers: Total Cholesterol
Time frame: Baseline - Week 12
To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on total cholesterol.
Change in Cardiometabolic Biomarkers: Cholesterol Efflux
Time frame: Baseline - Week 12
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.
Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total
Time frame: Baseline - Week 12
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.
Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total
Time frame: Baseline - Week 12
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.
Change in Cardiometabolic Biomarkers: Log Insulin
Time frame: Baseline - Week 12
To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log insulin.
Change in Cardiometabolic Biomarkers: Log Adiponectin
Time frame: Baseline - Week 12
To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log adiponectin.
Change in Cardiometabolic Biomarkers: Log Leptin
Time frame: Baseline - Week 12
To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log leptin.
Change in Cardiometabolic Biomarkers: Log C-reactive Protein
Time frame: Baseline - Week 12
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).
Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha
Time frame: Baseline - Week 12
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.
Change in Cardiometabolic Biomarkers: Log Interleukin 6
Time frame: Baseline - Week 12
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.
Change in Cardiometabolic Biomarkers: GlycA
Time frame: Baseline - Week 12
To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on GlycA
6 secondary outcomes
Change in Psoriasis Activity (PASI-75 and PGA)
Time frame: Baseline - Week 12
Change in Patient-reported Outcomes-EuroQol EQ-5D
Time frame: Baseline -Week 12
Change in Patient-reported Outcomes-Dermatology Life Quality Index (DLQI)
Time frame: Baseline - Week 12
Change in Patient-reported Outcomes-MEDFICTS Dietary Assessment)
Time frame: Baseline to Week 12
Change in Patient-reported Outcomes-International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline week 4, 8 and 12
Number of Patients With Adverse Events.
Time frame: Baseline - Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42694939Ramessur R, Kernizan F, Ranjbar E, Mehta NN, Alavi A, Shin DB, Iacobellis G, Gelfand JM. Adalimumab Reduces Epicardial Adipose Tissue in Psoriasis: A Post Hoc Analysis of a Randomized Placebo-Controlled Clinical Trial. Psoriasis (Auckl). 2026 Aug 30;16:628498. doi: 10.2147/PTT.S628498. eCollection 2026.
- Derived from this study: PubMed 31163241Noe MH, Wan MT, Shin DB, Armstrong AW, Duffin KC, Chiesa Fuxench ZC, Kalb RE, Menter A, Simpson EL, Takeshita J, Tyring SK, Van Voorhees AS, Mehta NN, Gelfand JM. Patient-reported outcomes of adalimumab, phototherapy, and placebo in the Vascular Inflammation in Psoriasis Trial: A randomized controlled study. J Am Acad Dermatol. 2019 Oct;81(4):923-930. doi: 10.1016/j.jaad.2019.05.080. Epub 2019 Jun 1.
- Derived from this study: PubMed 29776990Mehta NN, Shin DB, Joshi AA, Dey AK, Armstrong AW, Duffin KC, Fuxench ZC, Harrington CL, Hubbard RA, Kalb RE, Menter A, Rader DJ, Reilly MP, Simpson EL, Takeshita J, Torigian DA, Werner TJ, Troxel AB, Tyring SK, Vanderbeek SB, Van Voorhees AS, Playford MP, Ahlman MA, Alavi A, Gelfand JM. Effect of 2 Psoriasis Treatments on Vascular Inflammation and Novel Inflammatory Cardiovascular Biomarkers: A Randomized Placebo-Controlled Trial. Circ Cardiovasc Imaging. 2018 Jun;11(6):e007394. doi: 10.1161/CIRCIMAGING.117.007394.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Gelfand, MD MSCE principal investigator
University of Pennsylvania
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab (Humira) and NB-UVB phototherapy in people with Psoriasis and Cardiovascular Disease, run by University of Pennsylvania at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vascular Inflammation (time frame: Baseline - Week 12). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01553058, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.