Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pilot Study on the Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis
Brief Summary: This study is to determine the effect of adalimumab on inflammation of blood vessels that could lead to heart attack in patients with psoriasis. Changes to the carotid artery and ascending aorta will be evaluated in patients treated with adalimumab (systemic treatment) and compared against patients treated with a topical treatment that does not affect the entire body.


Options:
A: Inclusion Criteria:

* Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA \>/=3 and candidates for systemic therapy;
* Patients in good general health
* Able to self-administer injections
* Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis

Exclusion Criteria:

* Previous treatment with HUMIRA®
* Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA)
* Other active skin diseases or skin infections
* Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis
* Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix);
* History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB);
* History of moderate to severe congestive heart failure,
* Recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk;
* History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease;
* History of clinically significant drug or alcohol abuse in the last 12 months;
* Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline;
* Known hypersensitivity to the excipients of HUMIRA® as stated in the label;
* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
* Prior exposure to Tysabri® (natalizumab)
B: Inclusion Criteria:

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subjects who met the requirements from previous adalimumab psoriasis study participation.

Exclusion Criteria:

* Subject considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
* Female subject who was pregnant or breast-feeding or considering becoming pregnant.
C: Inclusion Criteria:

* 18-80 years old and capable of giving informed consent.
* at least a 6-month history of chronic moderate to severe psoriasis and a candidate for systemic therapy.
* BSA covered with psoriasis of at least 5 % or more at Baseline.
* An history of coronary atherosclerosis or at least three risk factors among the following: hypertension, active smoking, diabetes mellitus, dyslipidemia, obesity, microalbuminuria, age above 55 years, and first degree relative with coronary atherosclerosis before 65 years.
* Patient must be on a stable dose for at least 8 weeks before baseline if taking medications used to control angina, hypertension, serum lipids and any medication that can have an effect on inflammation.
* Patient has a carotid or ascending aorta atherosclerotic plaque inflammation target-to background ratio of 1.6 or more as determined by 18-FDG uptake measured by PET scanning.
* Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:

  * condoms, sponge, foams, jellies, diaphragm or IUD.
  * contraceptives for three months prior to study drug administration
  * a vasectomized partner.
* Female patient of childbearing potential must have a negative serum pregnancy test at the Screening visit.
* Patient is judged to be in good general health as determined by the principal investigator.
* Patient will be evaluated for latent TB infection with a PPD or a Quantiferon Gold test and CXR. Patient who demonstrates evidence of latent TB infection will only be allowed to participate in the study if they are willing to use TB prophylaxis according to Canadian guidelines
* Patient must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
* Patient must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.

Exclusion Criteria:

* Patient has other active skin diseases or skin infections (that may interfere with evaluation of psoriasis or with patient's safety.
* Patient has a history of an allergic reaction or significant sensitivity to constituents of study drug, including latex.
* Patient used any non-biological systemic therapy for the treatment of psoriasis less than 30 days before Day 0. Investigational chemical agents must be discontinued at least 30 days or five half-lives prior to the Baseline visit (whichever is longer).
* Patient who has used any biological therapy for the treatment of psoriasis less than 3 months (90 days) before Day 0.
* Patient is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
* Patient has used any topical treatment for psoriasis or has used phototherapy within the last 2 weeks prior to baseline (at the exception of low strength (hydrocortisone and desonide) topical corticosteroid for the face, groin (including genitals) and inframammary areas).
* Patient has received Anakinra/Kineret within the last 2 weeks prior to the Baseline visit or is likely to receive Anakinra/Kineret during the course of the study.
* Patient has a poorly controlled medical condition, such as uncontrolled diabetes, documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure a left ventricular ejection fraction of less than 40%, recent stroke, chronic leg ulcer or any other condition which, in the opinion of the investigator, would put the patient at risk if participating in the study.
* Patient had a myocardial infarction or hospitalization for a cardiac condition within the past 12 weeks.
* Patient has a history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, or carotid revascularization within 12 weeks of baseline.
* Patient for whom a change in medical treatment for angina, serum lipids, hypertension or any other medication that can have a significant effect on inflammation is planned for the duration of the study.
* Patient has a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
* Patient has history of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
* Patient has a history of listeriosis, treated or untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit.
* Patient has received any live attenuated vaccine 28 days or less before baseline.
* Patient with hepatitis B or hepatitis C viral infection.
* Patient with any of the following: hemoglobin = 10 g/L, white blood cell count = 3.0 X 109/L, platelet count =130 X 109/L, ALT = 2 times the upper limit of normal, AST = 2 times the upper normal limit, total bilirubin = 2 times the upper normal limit or creatinine = 150 umol/L.
* Patient is currently using or plans to use anti-retroviral therapy at any time during the study.
* Patient is known to have immune deficiency or is immunocompromised.
* Female patient who is pregnant or breast-feeding or considering becoming pregnant during the study or for 150 days after the last dose of study medication.
* Patient has a history of clinically significant drug or alcohol abuse in the last year.
* Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
D: Inclusion criteria:

* Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
* Severity of psoriasis disease meeting all of the following three criteria:

  * Psoriasis Area and Severity Index (PASI) score of 12 or greater
  * Investigator's Global Assessment (IGA) score of 3 or greater
  * Total body surface area (BSA) affected of 10% or greater
* Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria:

* Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
* Current drug-induced psoriasis.
* Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
* Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
* Hematological abnormalities.
* History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
* History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
* Pregnant or nursing (lactating) women.

Answer: C