Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase IIB, Multi-Dose, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis
Brief Summary: The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of active arthritis due to psoriatic arthritis in patients who have had a prior inadequate response to disease-modifying antirheumatic drugs, including methotrexate and tumor necrosis factor alpha-blockade compounds.


Options:
A: Inclusion Criteria:

* patients with psoriasis
* Age and sex matched patients with CAD, with untreated hypertension and healthy subjects

Exclusion Criteria:

* for psoriasis patients were presence of wall motion abnormalities and ejection fraction ≤ 50%, psoriatic arthritis, history of acute coronary syndrome, familial hyperlipidemia, insulin dependent-diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumors. CAD was excluded in psoriasis patients by absence of clinical history, angina and reversible myocardial ischemia, as assessed by dobutamine stress echocardiography or thallium scintigraphy
* regarding the group of CAD patients, we only included patients without history of ST elevation myocardial infarction in order to exclude the presence of transmural scar compromising myocardial function indices. Thus, CAD patients with wall motion abnormalities and ejection fraction of ≤ 50% were excluded. In addition, exclusion criteria, were history of acute coronary syndrome without ST-segment elevation within the last year, familial hyperlipidemia, insulin dependent-diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumor
* in normal controls, CAD was excluded by the presence of normal ECG, absence of clinical history and absence of reversible ischemia by means of treadmill test or dobutamine stress echocardiography
B: 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
C: Key Inclusion Criteria:

* Meeting classification criteria for psoriatic arthritis for a duration of disease of at least 3 months
* Prior failure (inefficacy or intolerance) of therapy with disease-modifying antirheumatic drugs; if patient had prior failure of methotrexate, he or she must have been taking at least 15 mg per week for at least 2 months
* If recent failure(inefficacy or intolerance) of a tumor necrosis factor α-blockade compound, participant must be washed out prior to first dose: 56 days for infliximab and 28 days for etanercept and adalimumab
* Disease activity as defined by a tender joint count of ≥3, swollen joint count of ≥3, and clinically detectable synovitis at screening and Day 01 (prior to infusion)
* Active psoriasis with a qualifying target lesion ≥2 cm in diameter
* Able to undergo magnetic resonance imaging
* Use of appropriate birth control by women of child bearing potential (WOCBP)

Key Exclusion Criteria:

* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of investigational product
* Women who are pregnant or breastfeeding or who plan to become pregnant or to start breastfeeding during the duration of the study
* Women with a positive pregnancy test on enrollment or prior to investigational product administration.
* Participants scheduled for or anticipating joint replacement surgery.
* Those with a recent history of clinically significant drug or alcohol abuse
* Concomitant illness that in the investigator's opinion is likely to require systemic glucocorticosteroid therapy during the study (for example: moderate to severe asthma)
* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, pulmonary, cardiac, neurologic, ophthalmologic, or cerebral disease.
* Unwillingness or inability to undergo screening based on current local or country guidelines/standards to evaluate the presence of cancer
* Cancer within the last 5 years
* Current malignancy or signs of possible malignancy detected by screening procedures for which the workup to exclude malignancy has not been completed or malignancy cannot be excluded
* At risk for or history (within 3 years) of tuberculosis
* Any serious bacterial infection within the last 3 months, not treated and resolved with antibiotics, or any chronic bacterial infection (such as, but not limited to, chronic pyelonephritis, osteomyelitis, and bronchiectasis)
* Evidence of active or latent bacterial or viral infection infections at the time of potential enrollment
* Herpes zoster or cytomegalovirus resolving less than 2 months prior to signing informed consent
* Receipt of any live vaccines within 3 months of the anticipated first dose of study medication or anticipation of the need for a live vaccine at any time during and for 3 months after the duration of the study

Long-term period participants: Must have met eligibility criteria for short-term period and completed short-term (24-week) period of the study
D: Inclusion Criteria:

* Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to enrollment;
* Candidate for phototherapy or systemic therapy;
* Premenopausal female participants must agree to abstain from heterosexual activity or use a medically approved method of contraception or use appropriate effective contraception as per local regulations or guidelines
* For the extension study: must have completed Part 3 of the base study
* For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study

Exclusion Criteria:

* Non-plaque forms of psoriasis
* Presence or history of severe psoriatic arthritis and is well-controlled on current treatment regimen
* Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
* Participant is expected to require topical therapy, phototherapy, or systemic therapy during the trial
* Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics
* Previous use of entanercept, tildrakizumab (MK-3222), or other interleukin-23 (IL-23)/T- helper cell 17 (Th-17) pathway inhibitors including p40, p19, and IL-17 antagonists
* Latex allergy or sensitivity
* Active or untreated latent tuberculosis (TB)
* For the extension study: women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or are breast feeding
* For the extension study: active or uncontrolled significant organ dysfunction or clinically significant laboratory abnormalities
* For the extension study: expected to require topical treatment, phototherapy, or systemic treatment during the extension study

Answer: C