Vascular Inflammation in Psoriasis - Extension Study
Condition: Psoriasis; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Psoriasis; Inflammation
Intervention: Adalimumab
Intervention description: 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.
Intervention MeSH terms: Adalimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Cardiovascular Disease; Vascular Inflammation; Lipid Biomarkers; Metabolic biomarkers; FDG-PET/CT

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.
    

Eligibility criteria:

        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.