Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.
Brief Summary: The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.


Options:
A: Inclusion Criteria:

(1) Male or non-pregnant, non-lactating females, 18 years of age or older. (2) Documented diagnosis of UC with disease extending at least 15 cm from the anal verge.

(3) Active UC defined by:

(a) modified UC-DAI score of 4-10 with (b) sigmoidoscopy component score ≥ 2 and (c) rectal bleeding component score ≥ 1 (4) Ability of subject to participate fully in all aspects of this clinical trial.

(5) Written informed consent must be obtained and documented.

Exclusion Criteria:

1. Severe UC defined by the following criteria:

   ³6 bloody stools daily with one or more of the following:
   1. oral temperature \> 37.8°C or \> 100.0°F
   2. pulse \> 90/min
   3. hemoglobin \< 10 g/dL
2. Previously failed treatment with a mesalazine dose of \> 2.0 g/day.
3. Current relapse lasting \> 6 weeks in the opinion of the investigator.
4. Treatment with 5-ASA at a dose of \>2.0g/day within 1 week prior to randomisation
5. Treatment with systemic or rectal steroids within 4 weeks prior to randomization.
6. Treatment with immunosuppressants within 6 weeks prior to randomization.
7. Treatment with infliximab or other biologics within 3 months prior to randomization.
8. Treatment with systemic antibiotics for UC within 7 days prior to randomization.
9. Treatment with probiotics within 7 days prior to randomization.
10. Treatment with anti-diarrheals within 7 days prior to randomization.
11. Treatment with nicotine patch within 7 days prior to randomization.
12. Received any investigational drug within 30 days prior to randomization.
13. History of colectomy or partial colectomy.
14. History of definite dysplasia in colonic biopsies.
15. Crohn's disease.
16. Known bleeding disorders.
17. Immediate or significant risk of toxic megacolon.
18. Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
19. Serum creatinine \> 1.5 times the upper limit of the normal range.
20. AST, ALT, total bilirubin or alkaline phosphatase \> 2 times the upper limit of the normal range.
21. Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
22. History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
23. Stools positive for clostridium difficile.
24. Pregnant or lactating women.
25. Prior enrolment in the current study and had received study treatment.
B: Inclusion Criteria:

* Patients suffering from active Crohn's disease \[Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450\] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8
* Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy

Exclusion Criteria:

* Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome
* History of tuberculosis or positive tests for tuberculosis at screening
* All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
C: 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.
D: Inclusion Criteria:

* Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
* Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450
* In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy)

Exclusion Criteria:

* Ulcerative colitis (UC) or indeterminate colitis
* Short bowel syndrome
* Known stricture or noninflammatory stenosis leading to symptoms of obstruction
* Current stoma or current need for colostomy or ileostomy

Answer: B