Please select the eligibility criteria that correspond to the clinical trial below.
Title: Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Brief Summary: Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.


Options:
A: 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 or recurrent 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
B: Inclusion criteria:

1. Men or women ≥ 18 and ≤ 75 years of age at time of screening
2. Stable moderate to severe plaque psoriasis for at least 6 months before baseline
3. Moderate to severe psoriasis defined at screening and baseline by:

   Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater
4. No known history of active tuberculosis
5. Subject is a candidate for systemic therapy or phototherapy procedures
6. Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy

Exclusion Criteria:

1. Forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema)
2. Ongoing use of prohibited treatments
3. Prior use of 2 or more biologics for treatment of psoriasis
4. Previous receipt of adalimumab or a biosimilar of adalimumab

Other Inclusion/Exclusion criteria may apply
C: 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.
D: 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)

Answer: D