Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence
Brief Summary: REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.


Options:
A: Inclusion Criteria:

* clinical diagnosis of Crohn's and proven history of disease
* patient undergone surgical resection with creation of a primary anastomosis

Exclusion Criteria:

* endoscopically inaccessible anastomosis by standard colonoscopy
* presence of an end stoma
* pregnancy
* suspected perforation of the gastrointestinal tract
* presence of certain unsuitable comorbidities
B: Inclusion Criteria:

1. Scheduled surgery for Crohn's disease (CD) with ileocolonic resection. Diagnosis of CD confirmed at least 4 months prior to surgery based on radiology and/or endoscopy.
2. Having an increased risk for postoperative relapse for any of the following reasons: (1) active inflammatory disease with C-reactive protein level (CRP) elevated above 10 mg/L, or the use of antibiotics, steroids or biological therapy including infliximab for active ileal disease within 2 months before surgery which were administered for Crohn's disease and not for another unrelated intercurrent inflammatory or infectious disease; (2) perforating disease defined as the presence of entero-enteric or enterocutaneous fistulas or perivisceral abscess formation within 2 months before surgery. Perianal fistulizing disease will not be considered as an indication of perforating disease in the ileum or right-sided colon. (3) Previous ileo-colonic resection, (4) active smoking, (5) age below 30.
3. Males and females 16-75 years old.
4. Curative surgical resection. All macroscopically inflamed colonic segments (except for anorectal involvement) are to be removed at surgery. Stricturoplasties in small bowel segments not involving the anastomotic region are allowed.
5. Patients able to start oral nutrition and oral therapy within 14 days from surgery.
6. Patients able and willing to give written informed consent
7. Women of childbearing potential should have a negative pregnancy test at inclusion.

Exclusion Criteria:

1. Patients who only had strictureplasties or ileal/colonic resection without a new ileo-colonic anastomosis. Patients with ileorectal anastomosis.
2. Patients with no increased risk of postoperative relapse as defined before.
3. Patients with a known intolerance to azathioprine/6-mercaptopurine or with known homozygous thiopurine methyltransferase-low mutation.
4. Patients in whom more than 100 cm of small bowel has been previously resected.
5. Patients with active perianal disease or colorectal stenosis precluding ileocolonoscopy
6. Patients with sepsis or other postoperative complications necessitating use of antibiotics for more than 14 days after surgery.
7. Patients with liver test abnormalities (serum glutamate oxaloacetate transaminase, serum glutamate pyruvate transaminase, alkaline phosphatase, bilirubin \> 2 ULN), leucopenia (\<3000 white blood cell count /µL, \<1500 neutrophils /µL), thrombopenia with \< 50.000 platelets/mm3.
8. Patients with severe renal, pulmonary or cardiac disease.
9. Pregnant or lactating women.
10. Ongoing alcohol or substance abuse.
11. Ongoing or recent (within 6 months) infectious disease (viral hepatitis, tuberculosis, AIDS, Herpes zoster related disease).
12. Known malignancy 5 years from surgery except for superficial epithelioma of the skin with curative resection.
C: Inclusion Criteria:

* Have a documented diagnosis of CD confirmed by endoscopic, histologic and/or radiologic studies prior to resection or by tissue obtained at resection
* Have undergone an ileocolonic surgical resection
* Patients must also be at an increased risk of recurrence of active CD
* Patients must not have previously discontinued infliximab as a result of tolerability issues or they must be naive to treatment with infliximab. Provided patients meet the above criteria pertaining to infliximab, they are eligible to enroll if they received prior treatment with adalimumab and/or certolizumab
* Patients must undergo screening for HBV
* Baseline CDAI \< 200
* Have adequate blood and liver test values

Exclusion Criteria:

* Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
* Have a chest radiograph within 3 months prior to the first infusion of study agent that shows a clinically significant abnormality, such as a malignancy or infection, or any abnormalities suggestive of TB
* Have macroscopically active CD which was not resected at the time of surgery
* Do not meet the criteria for being at an increased risk of postoperative recurrence of active CD as outlined in the inclusion criteria
* Have evidence of an active infection at the time of randomization or have had a serious infection not related to CD (e.g., hepatitis, pneumonia, or pyelonephritis), within 6 months prior to screening
* Have or have had an opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
* Have any known malignancy or history of malignancy within the 5-year period prior to screening (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence)
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
D: Inclusion Criteria:

* Age ≥ 18 years of age at the time of signing informed consent.
* Patients with Crohn's disease who have undergone an ileocecal/ileocolic resection (L1 or L3). The study and the treatment must be initiated within the two first weeks after the resection (+/- 5 days).
* Patients with surgical reconstruction by ileocolic anastomosis.
* Women of childbearing age must not be breastfeeding and must have a negative urine pregnancy test and must agree to use contraceptive methods with a \<1% failure rate (e.g., sexual abstinence, oral contraceptives, double barrier methods, intrauterine devices), unless they only have one partner who is sterile.
* Patients who have signed and dated the informed consent form before performing any specific screening study procedure.

Exclusion Criteria:

* Resection that requieres Temporal ileostomy.
* Urgency resection which doesn´t permit the initial assessment protocol completion.
* Resection due to inactive short indolent stenosis (\<10 cm).
* Resection with mucosal macroscopic residual disease in anastomosis.
* Previous intolerance or adverse reaction (moderate or severe) to adalimumab or azathioprine.
* Any contraindications or unwillingness to perform the scheduled colonoscopies or resonances.
* Contraindications to Adalimumab treatment, among which the following are included: active tuberculosis, severe infections such as sepsis or opportunistic infections, moderate or severe heart failure (NYHA class III or IV), central nervous system demyelinating diseases, history of malignant neoplasm or autoimmune diseases.
* Severe associated Extraintestinal manifestations.
* Previous postoperative recurrence prevention treatments with adalimumab, asathiprine o mercaptopurine which resulted in failure.
* Any other disease or patient condition that according to investigator criteria, inadequates patient´s participation in the study.

Answer: C