Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.


Options:
A: Inclusion Criteria:

* Participants who received all study agent administrations and completed the Week 6 Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
* Participants who completed the Week 0 visit for this maintenance study C0524T18 (NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)

Exclusion Criteria:

* Participants who increased the dose of their concomitant (given at the same time) UC medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
* Participants who initiated a concomitant UC medication since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
* Participants who had a partial or total colectomy (surgery to remove part or all of the colon) or an ostomy (surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
* Participants with signs or symptoms of latent or active granulomatous infection (including TB); a nontuberculous mycobacterial infection or opportunistic infection; or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C
* Participants with signs and symptoms of any malignancy or suggestive of a possible lymphoproliferative disease (disorders characterized by proliferation of lymphoid tissue, general or unspecified)
B: Inclusion Criteria:

* Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
* Mayo score ≥6 with an endoscopic subscore of ≥2
* Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)

Exclusion Criteria:

* Diagnosis of Crohn's Disease or Indeterminate Colitis
* Diagnosis of UC that is limited to the rectum
* Evidence of fulminant colitis, toxic megacolon, or bowel perforation
* Current need for a colostomy or ileostomy
* Previous total or subtotal colectomy
C: Inclusion Criteria:

* Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP);
* Mayo score of 6 to 10 points with moderate to severe disease on endoscopy
* Subjects on the following medications;

  1. prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration)
  2. 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration)
  3. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration)
  4. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug)

Exclusion Criteria:

* Anti-TNF therapy within 8 weeks before study drug administration
* Contraindication to colonoscopy or sigmoidoscopy
* Primary or secondary immunodeficiency
* Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism
* History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ
* Evidence of acute or chronic infection
* Clinically significant disease requiring medication
D: Inclusion Criteria:

* Men or women 18 years or older
* Ulcerative colitis for at lease 3 months
* Moderate to severe active ulcerative colitis
* Inadequate response or intolerance to standard ulcerative colitis treatment

Answer: C