Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Multicenter Placebo-controlled Trial on the Effect of Adalumumab on Vascular Inflammation in Patient With Moderate to Severe Psoriasis
Brief Summary: This study is a double-blinded randomized multicenter placebo controlled trial to determine the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in patients with moderate to severe psoriasis.


Options:
A: Inclusion Criteria:

Patient has plaque psoriasis. Patient has at least a 6 month history of plaque psoriasis.Patient has a Body Surface Area (BSA) covered with psoriasis of 5% or more at Day 0.

Patient is a candidate for systemic therapy. Patient is male or female, 18 to 80 years of age at time of consent. Patient's weight at screening is a maximum of 180 kg. Patient using medication to control angina, hypertension, serum lipids and any medication that can have an effect on inflammation must be on a stable dose for at least 8 weeks before Day 0.

Patient has an ascending aorta atherosclerotic plaque inflammation target-to-background ratio of 1.6 or more as determined by 18-FDG uptake measured by PET scanning.

Patient or patient's partner has been in a menopausal state for at least a year, is surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation or vasectomy), is clinically diagnosed infertile, has a same-sex partner, is abstinent, or is willing to use effective contraceptive method for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Effective contraceptive methods are:

1. Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
2. Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring;
3. Intrauterine device (IUD); Female patients 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 based upon the results of medical history, laboratory profile, physical examination, and CXR performed at Screening.

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 (either PPD more than or equal to 5 mm of induration or positive Quantiferon Gold, irrespective of Bacillus Calmette-Guerin (BCG) vaccination status and negative CXR findings for active TB, and/or suspicious CXR findings) will not be allowed to participate in the study.

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 spontaneously improving or rapidly deteriorating plaque psoriasis. Patient has other active infections (bacterial, fungal or viral) or skin diseases or skin infections (bacterial, fungal, or viral) 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 (a component of the pre-filled syringe).

Patient has used a non-biological systemic therapy for the treatment of psoriasis less than 30 days before Day 0.

Patient has used an investigational chemical or biological agent less than 30 days or 5 half-lives prior to the Day 0 visit (whichever is longer).

Patient has used a biological therapy for the treatment of psoriasis less than 90 days before day 0.

Patient has used a systemic immnosuppressor (eg. Azathioprine, 6-mercaptopurine) less than 30 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 a topical treatment for psoriasis or has used phototherapy within the last 2 weeks prior to Day 0 (at the exception of low potency topical corticosteroids for groin, genitals, face, inflammatory area, palms and soles).

Patient has received Anakinra/Kineret within the last 2 weeks prior to the Day 0 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, class III or IV (New York Heart Association Functional Classification; NYHA) congestive heart failure, an ejection fraction of less than 30%, recent stroke (within the past 3 months), 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 has had a myocardial infarction or has been hospitalized for a cardiac condition within the past 12 weeks.

Patient has a history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, carotid endarterectomy, stent installation or carotid revascularization within 12 weeks of Day 0.

Patient has had a percutaneous coronary intervention in the past 12 months. Patient plans for a change in medical treatment for angina, serum lipids, hypertension or any other medication that can have a significant effect on inflammation during the course of the study.

Patient has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease (e.g. optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia).

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 Tuberculosis (TB), persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infectives within 30 days prior to the Day 0 visit or oral anti-infectives within 14 days prior to the Day 0 visit.

Patient has received a live attenuated vaccine 28 days or less before Day 0 or plan to receive a live attenuated vaccine during the study and up to 4 months after the last study drug administration..

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 ≥ 3 times the upper normal limit, total bilirubin ≥ 2 times the upper normal limit or creatinine ≥ 150 µmol/L.

Patient currently uses 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 6 months after the last dose of study medication.

Patient has a history of clinically significant drug or alcohol abuse in the last year.

Patient who plans to travel in an area where tuberculosis is endemic during the study and up to 4 months after the last study drug administration.

Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
B: Inclusion Criteria:

* Must be at least 18 years of age
* Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
* Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5-point scale
* Subject is a candidate for systemic PSO therapy and/or phototherapy
* Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

* Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections
* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
* Presence of active suicidal ideation or positive suicide behavior
* Presence of moderately severe major depression or severe major depression
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
C: Inclusion Criteria:

1. Signed and personally dated written informed consent
2. Male / female
3. Aged 18 years or older
4. With a diagnosis of chronic plaque psoriasis for at least 12 months before enrollment in the study
5. With the severity of psoriasis defined as moderate to severe, as reflected in meeting all the following criteria:

   * PASI \> 10
   * BSA (body surface area) \> 10 %
   * PGA moderate to severe
6. With general good health, or a stable medical condition not considered likely to interfere with the conduct of the clinical study, as determined by the investigator based upon results of medical history, laboratory results and physical examination
7. Prior therapy with systemic drugs for psoriasis or naïve to systemic treatment but identified as a candidate for systemic treatment.
8. With a complete record of at least 12 months of other previous topical and systemic treatments, if any
9. Adhering to the following wash-out periods Topical treatment Wash-out Period Corticosteroids Vitamin A analogues Vitamin D analogues Anthracene derivatives Tar Salicylic acid preparations 2 weeks Systemic treatment Biologics with antipsoriatic activity 3 months Conventional systemic antipsoriatic drugs and phototherapy 1 month Immunosuppressive medication (if not covered by any of the above treatments) Cytostatics 6 months Medications with known harmful influences on the kidneys 5 x halftime
10. For females of child-bearing potential: a negative serum pregnancy test at screening and willing to use highly effective methods of birth control during the study period and for 60 days after the last dose of investigational product. Additionally they must agree to have pregnancy tests while on study medication. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
11. Males (including those who have had vasectomy) must agree to use barrier contraception while on study medication
12. Willing to keep sun exposure reasonably constant and not to use tanning booths or other UV light sources for the duration of the trial

Exclusion Criteria:

1. For females: pregnant or lactating
2. With a diagnosis of guttate, erythrodermic or pustular psoriasis
3. With a hematological abnormality as follows: platelet count \< 100,000/mm3, WBC count \< 3,000 cells/ mm3, lymphocyte count \< 1.000/µl, hemoglobin, hematocrit, or red blood cell count outside 30 % of the upper or lower limits of normal for the lab
4. With a history of malignancies except for non melanoma skin cancer
5. Suffering from significant gastrointestinal problems (ulcers, diarrhea, etc.)
6. Known to have significant renal impairment
7. Are detected to have abnormal liver enzymes \>2x the upper limit of the normal range
8. With active infectious disease
9. On systemic therapy with drugs that may interfere with the investigational products taken within the defined wash-out period
10. With a history of alcohol or drug abuse
11. Known HIV-positive status or suffering from any other immunosuppressive disease
12. Known to be hypersensitive to ingredients of the investigational products
13. Previous enrolled in this study or participating in any other drug investigational trial within the 30 days (or five half-lives whichever is longer) prior to enrolment.
14. Not willing to give consent for transmission of personal "pseudonymised" data
15. Unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study
D: Inclusion Criteria:

1. Male and female subjects between 18 and 75 years of age.
2. Moderate to severe plaque-type psoriasis for at least 6 months.
3. Subject is a candidate for systemic biologic therapy.
4. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.
5. Subject is able to comply with the study procedures.
6. Subject must provide informed consent.

Exclusion Criteria (Main):

1. Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).
2. Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C.
3. Laboratory abnormalities at screening, as defined in the study protocol.
4. Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
5. Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.
6. History of suicidal thoughts within 12 months.

Answer: A