Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Brief Summary: This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.


Options:
A: Inclusion Criteria:

1. More than 18 years of age
2. Patients suffering from one of the following chronic inflammatory intestinal disease:

   * Steroid-dependent Chron's Disease or Ulcerative Colitis following ECCO definition or mild-moderate active UC ( Powell Tuck between 3 and 14- an index of 14 was allowed; endoscopic Baron score \>1) refractory to mesalazine.
3. Disease extension over the rectum (at least 15 cm) in patients suffering from Ulcerative Colitis
4. Patients willing and be able to give written informed consent.

Exclusion Criteria:

1. Intestinal sub occlusion or a suspected abdomen abscess or a severe degree of the disease (CDAI \> 450) in patient suffering from Chron's Disease
2. Patient affected by a severe Ulcerative Colitis (more than 6 evacuations of liquid, mucous-blooding stools combined at least one systemic sign as body temperature \> 37.8 °C, heart rate \< 90 bpm, ESR \> 30 mm/h or haemoglobin \< 10.5 g/dL)
3. Severe concurrent disease(s) as:

   * Medullar deficit: white blood cells \< 3000/mm3; platelets \< 75000/mm3; haemoglobin \< 10 g/dL;
   * Hepatic diseases presenting total bilirubin ≥ 3 mg/dL; AST (GOT) ≥ 5 UNL; alkaline phosphatase ≥ 5 UNL:
   * Renal failure with serum creatinine ≥ 3 mg/dL;
   * Heart failure
   * Respiratory failure
   * Disabling neurological diseases
   * Neoplasia
   * Patient deemed candidate to surgery due to Chron's Disease or Ulcerative Colitis
   * Chronic alcohol or drug abuse
   * Patient for whom the use of steroids is contraindicated (e.g. systemic infections)
4. Treatment with Infliximab in the previous 4 months
5. Pregnant woman or female for whom the possibility of a pregnancy during the study could not be excluded.
6. Non-collaborating patient or subject unable to regularly undergo the scheduled study procedures.
B: Inclusion Criteria:

* Males and females, 18 years of age or older.
* Diagnosis of ulcerative colitis (UC) verified by endoscopy within 60 months prior to consent.
* Severe active disease, as defined by a Modified Truelove \& Witts Severity Index (MTWSI; also known as Lichtiger score) ≥ 11 at consent, with a confirmatory MTWSI ≥ 10 on or after the fifth consecutive day of intravenous (IV)steroids and within 1 day prior to randomization.
* Mayo score ≥ 10 and Mayo mucosal subscore ≥ 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids.
* Adequate contraception from the day of consent through 3 months after the last dose of study drug.
* Negative serum pregnancy test.
* Negative Clostridium difficile test.
* Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.

Exclusion Criteria:

* UC requiring immediate intervention or toxic megacolon requiring imminent intervention.
* History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis.
* Presence of Ileostomy.
* White blood cell count less than 2.5 x 10\^3/mcL; platelet count less than 150 x 10\^3/mcL; or hemoglobin level less than 8 g/dL.
* Active medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of medically significant opportunistic infections within the past 12 months.
* Live vaccination within 6 weeks prior to randomization.
* Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality.
* History of myocardial infarction, coronary artery disease, congestive heart failure, or arrythmias within 6 months prior to consent.
* History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).
* Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
* Pregnancy or nursing.
* Treatment with a first dose of infliximab or another anti-tumor necrosis factor (TNF)-α drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-α drug within 2 weeks of randomization.
* Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization.
* Treatment with any other investigational drugs or therapies within 60 days prior to randomization, except those mentioned in the two exclusion criteria above.
* Unable or willing to discontinue any UC drug (including, but not limited to 6-mercaptopurine, azathioprine, or methotrexate), except glucocorticoids or 5-ASA, immediately prior to randomization.
* Nontherapeutic levels of chronic antiseizure medications in subjects with a prior history of seizures.
* Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
C: Inclusion Criteria:

* Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month
* Greater than 18 years of age

Exclusion Criteria:

* Allergy/intolerance to aspirin, mesalamine, or other salicylates
* Prior bowel surgery other than appendectomy
* Pregnancy, at risk of pregnancy, or lactating
* HIV or hepatitis B or C
D: Inclusion Criteria:

* Diagnosis of moderate to severe ulcerative colitis outpatient
* Disease duration at time of screening of \>/= 12 weeks

Exclusion Criteria:

* Extensive colonic resection or subtotal or total colectomy
* Presence of an ileostomy or colostomy
* Moderate to severe anemia
* A history or evidence of colonic mucosal dysplasia
* Pregnant or lactating
* Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
* Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block
* Poorly controlled diabetes
* Impaired renal function
* Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis
* Positive tests for antibodies indicating active or prior infection with HIV or hepatitis B (HBV) or C (HCV)
* Positive screening test for latent mycobacterium tuberculosis (TB) infection
* Demyelinating disease
* Received any investigational treatment within 12 weeks prior to initiation of study treatment
* Previous exposure to rhuMAb Beta7

Answer: D