Vascular Inflammation in Psoriasis - Extension Study (VIP-E)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01866592
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : June 16, 2017
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Psoriasis Cardiovascular Disease Drug: Adalimumab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vascular Inflammation in Psoriasis - Extension Study
Study Start Date : April 2013
Actual Primary Completion Date : August 3, 2016
Actual Study Completion Date : August 3, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Arm Intervention/treatment
Single-Arm, open-label extension trial
Single-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.
Drug: Adalimumab
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.
Other Name: Humira

Primary Outcome Measures :
  1. Vascular Inflammation [ Time Frame: Baseline and Week 52 ]
    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 from the VIP trial and between week 52 of the adalimumab treatment period and week 12 scans from the VIP trial.

  2. Cardiometabolic Biomarkers [ Time Frame: Baseline - Week 52 ]
    Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial and between week 52 of the adalimumab treatment period and week 12 assessments from the VIP trial.

Secondary Outcome Measures :
  1. Psoriasis Activity (PASI and PGA) [ Time Frame: Baseline - Week 52 ]
    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).

  2. Safety/Adverse Events [ Time Frame: All visits through 52 week study ]
    Safety will be assessed by evaluating all subject reported adverse events through the duration of the study.

  3. Patient-Reported Quality of Life Outcomes [ Time Frame: Baseline - Week 52 ]
    Patient reported quality of life outcomes will be assessed using the following standard instruments: EuroQol EQ-5D, Dermatology Life Quality Index (DLQI), MEDFICTS dietary assessment instrument, International Physical Activity Questionnaire (IPAQ), and Multidimensional Health Assessment Questionnaire (MDHAQ).

  4. Cardiometabolic Biomarkers [ Time Frame: Intermediate time points between baseline and week 52 ]
    Change in metabolic, lipid, and inflammatory biomarker levels at intermediate time points.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males and females 18 years of age and older.
  2. Subject completed the VIP Study
  3. 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
  4. Subject is willing and able to avoid topical or systemic prescription treatments for psoriasis besides adalimumab during the course of the study
  5. Women are eligible to participate in the study if they meet one of the following criteria:

    1. 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:

      • 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.
    2. Women who have undergone tubal ligation
    3. Women who are postmenopausal (for at least one year), sterile, or hysterectomized are eligible to participate
    4. 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.
  6. 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.
  7. Able and willing to give written informed consent and to comply with requirements of this study protocol.

Exclusion Criteria:

  1. Previous adverse event following exposure to a TNF-alpha antagonist that led to discontinuation of the TNF inhibitor and contraindicates future treatment.
  2. Previous lack of response to a TNF-alpha antagonist led to discontinuation.
  3. Diagnosis of erythrodermic psoriasis, generalized pustular psoriasis, or medication-induced or medication-exacerbated psoriasis.
  4. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
  5. Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
  6. 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.
  7. 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%)
  8. Uncontrolled hypertension, with measured systolic blood pressure >180 mmHg or diastolic blood pressure >90 mmHg
  9. History of demyelinating diseases or lupus.
  10. 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.
  11. 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.
  12. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
  13. 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)
  14. Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
  15. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01866592

United States, California
University of California, Davis Health System
Sacramento, California, United States, 95816
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80045
United States, Maryland
National Heart, Lung, and Blood Institute
Bethesda, Maryland, United States, 20892
United States, New York
Buffalo Medical Group
Buffalo, New York, United States, 14221
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Center for Clinical Studies
Houston, Texas, United States, 77004
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: Joel M Gelfand, MD MSCE University of Pennsylvania

Responsible Party: University of Pennsylvania Identifier: NCT01866592     History of Changes
Other Study ID Numbers: 817552
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

Keywords provided by University of Pennsylvania:
Cardiovascular Disease
Vascular Inflammation
Lipid Biomarkers
Metabolic biomarkers

Additional relevant MeSH terms:
Cardiovascular Diseases
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Antirheumatic Agents