Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled study evaluating rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks. The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using a standard disease activity index. Calculation of the index requires patients to undergo flexible sigmoidoscopy at the start of the study and at week 12.


Options:
A: Inclusion Criteria:

* Diagnosed ulcerative colitis at least 90 days prior randomisation.
* Men or women age 18 - 75 years.
* Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5-aminosalicylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization.
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1.
* Nonsterilized males or sterilized males who are ≤1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* History of colostomy.
* Current diagnosis of indeterminate colitis, Crohn's disease, ischemic colitis, fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited to the rectum (ulcerative proctitis).
* Hepatitis B, C or HIV.
* History of cancer.
B: Inclusion Criteria:

In addition to others,

* Men or women age 18-75
* Diagnosis of ulcerative colitis confirmed through screening endoscopy.
* Extent of disease must involve at least the left colon
* Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present.
* Inadequate response despite treatment with prednisone 40 - 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry

Exclusion Criteria:

In addition to other protocol-defined conditions,

* Pregnancy
* Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin
* Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings
* Severely ill patients as evidenced by protocol-defined systemic criteria
* Chest radiograph abnormalities consistent with an infectious process
* History of colonic dysplasia
* HIV infection
* Known viral Hepatitis B or C infection
* History of or exposure to tuberculosis within 6 months before study entry
C: INCLUSION CRITERIA: Participants must meet the following criteria for inclusion in the trial:

* Must sign and date the informed consent form
* At least 18 years of age
* Documented diagnosis (endoscopic, surgical or x-ray) of ulcerative colitis (UC)
* Mild to moderate ulcerative colitis indicated by Disease Activity Index score of greater than or equal to 4 and less than or equal to 10
* Unless the patient is intolerant of oral 5-ASA therapy, patient must be treated with a minimum of 2 gm daily of an oral 5-ASA agent for a minimum of 4 weeks during the current exacerbation of ulcerative colitis or immediately prior to study entry
* If treated with oral corticosteroids, dose must not exceed 20 mg per day of Prednisone or equivalent
* If treated with corticosteroids, dose must be stable for 4 weeks prior to study entry and remain on same dose throughout
* If treated with 6-mercaptopurine or azathioprine, must have been on medication for 4 months and a stable dose for 2 months prior to study entry
* If a female of childbearing age, the participant must have a negative serum pregnancy test and have been using a medically approved form of contraceptive birth control for 3 months prior to enrollment. Participants, both male and female, must also be willing to use medically approved contraceptive birth control (at least one barrier method) throughout the study
* If treated with rectal therapy, dose must be stable for 2 weeks prior to study entry and remain on same dose throughout

EXCLUSION CRITERIA: Participants will be ineligible for participation in the trial if they meet any of the following criteria:

* Severe ulcerative colitis indicated by Disease Activity Index score of greater than 10
* Class III or IV congestive heart failure by NYHA classification system
* Allergy to thiazolidinediones
* Presence of any medical condition with an expected survival of less than 1 year
* Participants receiving therapy with cyclosporin, anti-TNF therapy, or methotrexate within the last 2 months of screening
* Positive stool culture for enteric pathogens (salmonella, shigella, and campylobacter), positive C.difficile toxin, or positive stool ova and parasite exam
* Positive proteinuria by urine dipstick
* History of chronic liver disease or baseline liver chemistries greater than the upper limit of normal
* Diabetes mellitus requiring hypoglycemic agents
* Participation in study of experimental therapy within 2 months of first screening visit
* Has any of the following laboratory abnormalities: WBC \< 3,000 per uL, Neutrophil \< 1,000 cell/cu.mm, Platelets \<75,000 per uL, INR \> 1.2
* Participant is female and is pregnant or currently breastfeeding
D: Inclusion Criteria:

* Patients who have had ulcerative colitis of at least 3 months' duration at screening
* Patients who have ulcerative colitis confirmed by the biopsy taken at screening
* Patients must have active colitis confirmed during the screening sigmoidoscopy
* Patients must have active disease.

Exclusion Criteria:

* Patients must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study
* Patients must not require, or required within the 2 months prior to beginning the study, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage

Answer: C