Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
Brief Summary: The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.


Options:
A: Inclusion Criteria:

* Adults over 18 years of age with a diagnosis of chronic moderate to severe plaque psoriasis for at least 12 months; in generally good health; on stable dose of non-prohibited medications; able to stop current psoriasis therapy (systemic or topical) for several weeks prior to and during study participation.

Exclusion Criteria:

* Serious underlying disease including viral disorders such as hepatitis or HIV or skin condition that would interfere with skin biopsies or evaluation of psoriasis; conditions that could interfere with drug absorption after oral administration; history of malignancy or auto-immune disease.
* Use of oral or injected corticosteroids (steroids).
B: Inclusion Criteria:

* Subject is male or female, \>= 20 years of age.
* Institutional Review Board-approved written informed consent form is signed and dated by the subject.
* Other protocol-defined inclusion criteria may apply.

For subjects with moderate to severe chronic plaque psoriasis (PSO)

* Chronic plaque psoriasis for at least 6 months.
* Baseline Psoriasis Activity and Severity Index (PASI) \>=12 and Body Surface Area (BSA) affected by PSO \>=10% and Physician's Global Assessment (PGA) score of 3 or higher.
* Candidates for systemic PSO therapy and/or phototherapy and/or chemophototherapy.

For subjects with generalized pustular PSO or erythrodermic PSO

* Diagnosis of generalized pustular PSO or erythrodermic PSO at Screening.
* History of plaque-type PSO if subjects have a diagnosis of erythrodermic PSO.
* Baseline BSA affected by PSO \>=80% if subjects have a diagnosis of erythrodermic PSO.

Exclusion Criteria:

* Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 5 months following last dose of study drug. Male subject who is planning a partner pregnancy during the study or within 5 months following the last dose of study drug.
* Subject has guttate psoriasis or drug-induced psoriasis. For subjects with moderate to severe plaque psoriasis, erythrodermic or pustular forms of psoriasis also are excluded.
* History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol. Also, subjects with a high risk of infection in the Investigator's opinion.
* History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
* History of other malignancy or concurrent malignancy as described in the protocol.
* Class III or IV congestive heart failure
* History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis).
* Subject has any other condition which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study.
* Concurrent medication restrictions as described in the protocol.
* Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or with untreated latent tuberculosis infection (LTBI) or current or history of nontuberculous mycobacterial (NTMB) infection.
* Subject has any protocol defined clinically significant laboratory abnormalities at the screening
* Other protocol-defined exclusion criteria may apply.
C: Inclusion Criteria:

* 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area
* A Psoriasis Area and Severity Index (PASI) score of 12 or greater
* Are considered to be candidates for systemic or light therapy
* Have no evidence of active or latent tuberculosis

Exclusion Criteria:

* Non-plaque or drug-induced forms of psoriasis
* Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
* Any uncontrolled significant medical condition
D: 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.

Answer: B