Please select the eligibility criteria that correspond to the clinical trial below.
Title: Vascular Inflammation in Psoriasis - Extension Study
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.


Options:
A: Inclusion Criteria:

* Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline.
* Participants who are candidates for systemic therapy and who are naive to systemic treatment for psoriasis.
* Have a (PASI score \>10 or BSA \>10) and DLQI \>10 at screening and at baseline.

Exclusion Criteria:

* Have predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
* Have received systemic nonbiologic psoriasis therapy.
* Have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis therapy.
* Have any condition or contraindication as addressed in the local labeling for MTX or FAE.
* Presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders or abnormal laboratory values at screening.
* Have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal ulcer.
* Have had a serious infection or are immunocompromised.
* At screening, participants with significant, present, or early liver disease, e.g., explained by alcohol consumption or hepatic insufficiency.
B: Inclusion Criteria:

* Men or women at least 18 years of age at time of consent
* Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
* At time of randomization, moderate to severe psoriasis as defined by:

  * PASI score of 12 or greater and
  * IGA score of 3 or greater and
  * Body Surface Area (BSA) affected by plaque-type psoriasis of 10 % or greater
* At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by:

  * topical treatment and/or
  * phototherapy and/or
  * previous systemic therapy

Exclusion Criteria:

* Patients meeting any of the following criteria will be excluded from entry into the study:
* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
* Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization
* Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to
* Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration
* Known immunosuppression (e.g., AIDS) at screening and / or randomization
* History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
* Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)
* At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
* History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization
* History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization
* Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
* Pregnant or nursing (lactating) women
C: Inclusion Criteria:

* Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
* At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
* Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization
* Candidate for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control during the study
* Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Clinically significant flare of psoriasis during the 12 weeks prior to randomization
* Concurrent or recent use of any biologic agent
* Received systemic psoriasis therapy \[such as psoralen and ultraviolet A (PUVA) light therapy\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
* Have participated in any study with interleukin (IL)-17 antagonists, including LY2439821
* Serious disorder or illness other than plaque psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women.
D: 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.

Answer: D