Please select the eligibility criteria that correspond to the clinical trial below.
Title: Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence: Systematic Versus Endoscopic-directed Treatment. A Multi-center, Randomized, Clinical Practice Evaluation Study.
Brief Summary: The objective of this study is to evaluate if in the prevention of postoperative recurrence of ileal Crohn's disease immediate initiation of azathioprine postoperatively is superior to delayed (6- 12 mths.) introduction of azathioprine upon disease recurrence assessed by endoscopic criteria. The primary endpoint, disease recurrence, encompasses symptomatic and surgical recurrence as well as severe endoscopic lesions at the final, 2 year, assessment.


Options:
A: 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.
B: Inclusion Criteria:

* Diagnosis of Crohn's Disease for greater than 4 months.
* A diagnosis of ileocolonic Crohn's Disease confirmed by endoscopy or radiologic evaluation within 3 years of Baseline.
* For subjects who have had operations in the ileocolonic region of the intestine after documented diagnosis of ileocolonic disease, postoperative recurrence of the disease must be documented.
* Endoscopic documentation of ulceration at Screening corresponding to a score of 2 or 3 in at least one of the five segments of the colon on the Ulcerated Surface subscore of the Simple Endoscopic Score for Crohn's Disease (SES-CD).
* Crohn's Disease Activity Index (CDAI) score of \>= 220 and \<= 450.
* Males and females \>= 18 and \<= 75 years of age at the Baseline visit.
* Adequate cardiac, renal and hepatic function as determined by the Principal Investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that do not indicate an abnormal clinical condition which would place the subject at undue risk and thus preclude subject participation in the study.
* Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication.
* Subjects must agree to undergo up to 4 endoscopies.

Exclusion Criteria:

* History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma - in-situ of the cervix.
* History of listeria, human immunodeficiency virus (HIV), hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease, or untreated tuberculosis (TB).
* Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the Investigator and Abbott Medical Monitor.
* Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
* Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
* Subject who has received any investigational biological agent in the past 3 months or 5 half-lives prior to Baseline (whichever is longer).
* Subjects with a poorly controlled medical condition and any other condition which, in the opinion of the Investigator or the sponsor, would put the subject at risk by participation in the protocol.
* Subject who has previously used infliximab or any anti-TNF (anti tumor necrosis factor), even investigational, within 8 weeks of Baseline.
* Subject who has previously used infliximab or any anti-TNF agent and has not clinically responded.
* Previous treatment with adalimumab or previous participation in an adalimumab clinical study.
* Subjects on prednisone \> 40 mg/day (or equivalent).
* Subjects on budesonide \> 9 mg/day.
* Subjects with any prior exposure to Tysabri® (natalizumab).
* Subjects with a previous history of dysplasia of the gastrointestinal tract, or found to have dysplasia in any biopsy performed during the Screening endoscopy.
C: Inclusion Criteria:

* men/women \> 18 years of age
* curative resection/ileocolonic anastomosis for Crohn's disease
* may have received previously received infliximab
* if on oral aminosalicylates or corticosteroids, dose must be stable for 4 weeks prior to surgery
* if on 6-mercaptopurine,azathioprine or methotrexate,individual must have been on it for minimum of 3 months prior to surgery with stable dose for 4 weeks
* men and women must use adequate birth control for duration of study and for 6 months after receiving the last infusion
* antibiotics for treatment of Crohn's disease must be discontinued within 12 weeks after surgery; antibiotics are allowable throughout study as long as primary purpose of antibiotic therapy is not for primary treatment of Crohn's disease
* screening lab results must meet screening criteria (hemoglobin = or \> 8.5g/dL; Serum glutamic oxaloacetic transaminase ,3 times upper normal limit,platelets =or\> 100 x 10 9th/L; lymphocytes count =or\> 0.5 x 10 9th/L and neutrophils =or\> 1.0 x 10 9th/L
* have a documented negative reaction to a purified protein derivative skin test performed within 3 months prior to baseline
* have a normal chest radiograph results within 3 months prior to baseline
* are capable of providing written informed consent and obtained prior to conducting any protocol-specified procedures
* willing to adhere to the study visit schedule and other protocol requirements
* are considered eligible according to the tuberculosis eligibility assessment, screening and early detection of reactivation rules
* patients who undergo resective surgery and primary ileocolonic anastomosis with a temporary ileostomy upon takedown of the diverting ileostomy.

Exclusion Criteria:

* patients with greater than 10 years of Crohn's disease requiring first resection of a short (\<10cm) fibrostenotic stricture
* macroscopically active disease at anastomosis at time of surgery
* presence of stoma
* prior severe infusion reaction to infliximab
* history of anaphylaxis to murine products or other chimeric proteins
* any of the following medications taken within 12 weeks of surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, investigational drugs, or medications targeted at reducing tumor necrosis factor
* have a positive stool culture for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin and have clinically significant signs of an enteric infection at screening
* women who are pregnant, nursing or planning pregnancy during the trial or within 6 months after the last infusion
* patient with active tuberculosis, patient newly diagnosed with latent tuberculosis who's receiving tuberculosis prophylaxis, patient with recent close contact to individual with active tuberculosis
* have or have had opportunistic infection within 6 months of screening
* have chest radiograph within 3 months prior to screening that shows malignancy, infection, or abnormalities suggestive of tuberculosis
* documentation of seropositive for HIV
* documentation of a positive test for hepatitis B surface antigen or a history of documented hepatitis C
* have current signs/symptoms of systemic lupus erythematosus, or severe progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral diseases
* presence of a transplanted solid organ (with exception of corneal transplant \> 3 months prior to randomization)
* Have any current or known malignancy or have history of malignancy within 5 years of screening(except for squamous or basal cell carcinoma of the skin that has been fully excised with no evidence of recurrence)
* have history of lymphoproliferative disease or splenomegaly
* have known substance abuse(drug/alcohol)/dependency within the previous 3 years, history of noncompliance with medical regimens, or other condition that may interfere with adherence to protocol requirements
* are unwilling/unable to undergo multiple venipunctures because of poor tolerability or lack of easy access
* known history of demyelinating disease
* a chronic or recurrent infectious disease
* serious infection, hospitalization for infection, or treatment with IV antibiotics for infection within 2 months prior to randomization
* a serious concomitant illness that may interfere with participation in trial
* concomitant diagnosis/history of congestive heart failure
* current use of prescription doses or chronic/frequent use of non-steroidal anti-inflammatory drugs
* ulcerative colitis
* concurrent participation in another investigative trial
* use of any investigational drug within 30 days prior to randomization
D: Inclusion Criteria:

* age 16 - 75 years
* diagnosis of Crohn's disease within the past 4 years
* no previous treatment with corticosteroids, antimetabolites, or biologic agents.
* Active Crohn's disease, defined by a Crohn's Disease Activity Index (CDAI)20 score of greater than 200 points for a minimum of 2 weeks prior to randomization.

Exclusion Criteria:

* immediate need for surgery
* symptomatic stenosis or ileal/colonic strictures with prestenotic dilatation;
* signs, symptoms or laboratory tests indicating severe, medical disease;
* documented chronic infection
* a positive stool culture for pathogens
* a positive tuberculin test or a chest radiograph consistent with tuberculosis.
* malignancy
* allergy to murine proteins
* pregnancy
* substance abuse

Answer: A