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PsoriasisPhase 4VIP-ENCT01866592

Vascular Inflammation in Psoriasis - Extension Study

A Phase 4 study testing Adalimumab in people with Psoriasis and Cardiovascular Disease, run by University of Pennsylvania at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
9 sitesUnited States
Study dates
Apr 2013to 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.
  • Subject completed the VIP Study
  • Subject willing and able to avoid prolonged exposure of skin affected by psoriasis to natural or sunlight or tanning beds during the course of the study
  • Subject is willing and able to avoid topical or systemic prescription treatments for psoriasis besides adalimumab during the course of the study
  • Women are eligible to participate in the study if they meet one of the following criteria:
  • Women of childbearing potential must undergo pregnancy testing during the baseline visit and agree to use one of the following methods of contraception throughout the 13-month study:
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  • Oral contraceptives;
  • Transdermal contraceptives
  • Injectable or implantable methods
  • Intrauterine devices
  • Barrier methods (for example but not limited to a diaphragm with spermicide, condom with spermicide); or
  • Vasectomized partner
  • Subjects using oral or parental forms of contraceptives must have been using those methods of birth control for at least three months prior to the baseline visit.
  • Women who have undergone tubal ligation
  • Women who are postmenopausal (for at least one year), sterile, or hysterectomized 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, and physical examination.
  • 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 that led to discontinuation of the TNF inhibitor and contraindicates future treatment.
  • Previous lack of response to a TNF-alpha antagonist led to discontinuation.
  • Diagnosis of erythrodermic psoriasis, generalized pustular psoriasis, or medication-induced or medication-exacerbated psoriasis.
  • Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
  • 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.
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  • History of diabetes mellitus, type 1 or type 2 (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:
  • 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 as determined within 6 months of the baseline visit for VIP-E; 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 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 within the past five years 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.
  • Clinic 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
  • 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)
  • Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
  • If subject is on cholesterol-lowering medication (e.g. statin), dose and form of medication must be stable for 90 days prior to baseline and remain stable throughout the duration of the study.

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

  • University of Colorado

    Denver, Colorado, 80045

  • Center for Clinical Studies

    Houston, Texas, 77004

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of California, Davis Health System

    Sacramento, California, 95816

  • University of Utah

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E extends VIP study procedures for 40-52 weeks including questionnaires, physical exams, blood and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab injections following FDA-approved psoriasis treatment regimen.

Being tested
Adalimumab
Keywords
Psoriasis, Cardiovascular Disease, Vascular Inflammation, Lipid Biomarkers, Metabolic biomarkers, FDG-PET/CT
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.

  • AdalimumabDrug

    Also called Humira

    Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.

Study groups in NCT01866592
Study groupRoleWhat they receive
Single-Arm, open-label extension trialOtherSingle-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Vascular Inflammation

    Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between week 52 of the adalimumab treatment period and baseline scans (prior to randomization in the VIP Trial). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUIV mean yielding a target to background ration (TBR). If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  2. Change in Vascular Inflammation

    Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between week 52 of the adalimumab treatment period and start of adalimumab.The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUIV mean yielding a target to background ration (TBR).

    Measured: 52 weeks of adalimumab treatment

  3. Change in Cardiometabolic Biomarker - Total Cholesterol

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Total Cholesterol. If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  4. Change in Cardiometabolic Biomarker - Cholesterol Efflux

    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)].

    If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  5. Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Low-density lipoprotein particle If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  6. Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - High-density lipoprotein particle If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  7. Change in Cardiometabolic Biomarker - Log Insulin

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Insulin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  8. Change in Cardiometabolic Biomarker - Log Adiponectin

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Adiponectin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  9. Change in Cardiometabolic Biomarker - Log Leptin

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Leptin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  10. Change in Cardiometabolic Biomarker - Log C-reactive Protein

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log C-reactive protein If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  11. Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Tumor Necrosis Factor-Alpha If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  12. Change in Cardiometabolic Biomarker - Log Interleukin 6

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Interleukin 6 If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  13. Change in Cardiometabolic Biomarker - GlycA

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - GlycA If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  14. Change in Cardiometabolic Biomarkers: - Total Cholesterol

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and the start of adalimumab - Total Cholesterol

    Measured: 52 weeks of adalimumab treatment

  15. Change in Cardiometabolic Biomarker - Cholesterol Efflux

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Cholesterol Efflux

    Measured: 52 weeks of adalimumab treatment

  16. Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Low-density lipoprotein particle

    Measured: 52 weeks of adalimumab treatment

  17. Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - High-density lipoprotein particle

    Measured: 52 weeks of adalimumab treatment

  18. Change in Cardiometabolic Biomarker - Log Insulin

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Insulin

    Measured: 52 weeks of adalimumab treatment

  19. Change in Cardiometabolic Biomarker - Log Adiponectin

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Adiponectin

    Measured: 52 weeks of adalimumab treatment

  20. Change in Cardiometabolic Biomarker - Log Leptin

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Leptin

    Measured: 52 weeks of adalimumab treatment

  21. Change in Cardiometabolic Biomarker - Log C-reactive Protein

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log C-reactive protein

    Measured: 52 weeks of adalimumab treatment

  22. Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Tumor Necrosis Factor-Alpha

    Measured: 52 weeks of adalimumab treatment

  23. Change in Cardiometabolic Biomarker - Log Interleukin 6

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Interleukin 6

    Measured: 52 weeks of adalimumab treatment

  24. Change in Cardiometabolic Biomarker - GlycA

    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - GlycA

    Measured: 52 weeks of adalimumab treatment

Secondary outcomes (6)

  1. Psoriasis Activity (PASI and PGA)

    Change in psoriasis activity will be assessed using the following standardized measurement tools for psoriasis: Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). PASI combines the assessment of the severity of lesions and the area affected into a single score with range 0 (no disease) to 72 maximal disease. The PGA is an average assessment of all psoriatic lesions based on erythema, scale, and induration with score range 0 (no disease/clear) to 5 (maximal disease).

    If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  2. Safety/Adverse Events

    Safety will be assessed by evaluating all subject reported adverse events through the duration of the study.

    Measured: Baseline - Week 52

  3. Change in Patient-Reported Quality of Life 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: 52 weeks (continuation group) or 64 weeks (crossover group)

  4. Change in Patient-Reported Quality of Life Outcomes - Dermatology Life Quality Index (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.

    If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  5. Change in Patient-Reported Quality of Life 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. This assessment looks at eight different categories of foods and assigns points by type of food and serving size ranging from 0 points (do not consume that food group) to 21 points (consume food group, largest serving size). Your final score is the total of all points for all food categories.

    If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

  6. Change in Patient-Reported Quality of Life Outcomes - International Physical Activity Questionnaire (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.

    Per Office of Disease Prevention and Health Promotion's Physical Activity Guidelines:

    A range of 500 to 1,000 MET-minutes of activity per week provides substantial [health] benefit, and amounts of activity above this range have even more benefit. Amounts of activity below this range also have some benefit. The dose-response relationship continues even within the range of 500 to 1,000 MET-minutes, in that the health benefits of 1,000 MET-minutes per week are greater than those of 500 MET-minutes per week.

    If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).

    Measured: 52 weeks (continuation group) or 64 weeks (crossover group)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2013 (estimated)
  2. Study startApr 2013
  3. Primary completion8 Aug 2016
  4. Study completion27 Oct 2016

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01866592
Sponsor's protocol ID
817552
Acronym
VIP-E
Status last verified
Apr 2018
First submitted
16 May 2013
Last updated
22 May 2018
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 42694939

  • Mehta 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adalimumab 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 18 inclusion and 29 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. 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: 52 weeks (continuation group) or 64 weeks (crossover group)). The study lists 24 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 NCT01866592, which also lists 2 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.

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