Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.
Brief Summary: The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.


Options:
A: Inclusion Criteria:

* Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month
* Greater than 18 years of age

Exclusion Criteria:

* Allergy/intolerance to aspirin, mesalamine, or other salicylates
* Prior bowel surgery other than appendectomy
* Pregnancy, at risk of pregnancy, or lactating
* HIV or hepatitis B or C
B: Inclusion Criteria:

* Patients fulfilling the following criteria at the screening visit are eligible for participation in the study:

  * Male and female patients, 18-75 years old, suffering from ulcerative colitis for at least 6 months.
  * Diagnosis of ulcerative colitis in active phase, of mild or moderate entity with Ulcerative Colitis Disease Activity Index (UCDAI) ≥ 4 and ≤ 10 according to Sutherland.
  * All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrollment. In addition, all females of child-bearing potential must agree to be completely abstinent or be using an accepted form of contraception throughout the entire study period. Accepted forms of contraception are defined as those with a failure rate \<1% when properly applied and include: combination oral pill, some intra-uterine devices, and a sterilised partner in a stable relationship. Female subjects must also not be actively breast-feeding through the entire study period.
  * Ability to comprehend the full nature and purpose of the study, including possible risks and side effects.
  * Ability to co-operate with the investigator and to comply with the requirements of the entire study.
  * Must be able to understand and voluntarily sign written informed consent prior to inclusion in the study.

Exclusion Criteria:

* Patients who meet any of the following criteria at screening visit are to be excluded from study participation:

  * Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line).
  * Patients with severe ulcerative colitis (UCDAI \>10).
  * Patients with infectious colitis.
  * Evidence or history of toxic megacolon.
  * Severe anemia, leucopenia or granulocytopenia.
  * Use of oral or rectal steroids in the last 4 weeks.
  * Use of immuno-suppressive agents in the last 8 weeks before the study.
  * Use of anti tumor necrosis factor alpha (anti-TNFα) agents in the last 3 months.
  * Concomitant use of any rectal preparation.
  * Concomitant use of antibiotics.
  * Concurrent use of cytochrome P450 3A4 (CYP3A4) inducers or CYP3A4 inhibitors.
  * Patients with intolerance to salicylates.
  * Patients with verified, presumed or expected pregnancy or ongoing lactation.
  * Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoral parameters (i.e. 2 x upper limit of normal for alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma glutamyl transpeptidase \[GGT\] or creatinine).
  * Patient with severe diseases in other organs and systems.
  * Patients with local or systemic complications or other pathological states requiring a therapy with corticosteroids and/or immuno-suppressive agents.
  * Patients diagnosed with type 1 diabetes.
  * Patients diagnosed with, or with a family history of, glaucoma.
  * All patients with known hepatitis B, hepatitis C or with human immunodeficiency virus (HIV), according to the local privacy policy.
  * Participation in experimental therapeutic studies in the last 3 months. (Note: patients who participated in observational only studies are not excluded).
  * Any other medical condition that in the principal investigator's opinion would make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events (AEs).
C: Inclusion Criteria:

* Patients must be at least 18 years of age at screening
* Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study.
* Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ≥6
* Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline.

Exclusion Criteria:

* Diagnosis of Crohn's disease or diagnosis of indeterminate colitis
* Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis
* Patients that are currently receiving immunosuppressants, anti-TNFα therapy or interferon
D: Inclusion Criteria:

* Men or women aged 18 75, inclusive
* Established diagnosis of ulcerative colitis involving the sigmoid colon or proximal segments of bowel
* Total Mayo score between 5-12, inclusive, with endoscopic subscore of the Mayo score ≥ 2 and \> 15 cm of involvement beyond the anal verge

Exclusion Criteria:

* Women with a positive pregnancy test, who are breastfeeding, or who intend to become pregnant during the course of the study
* Diagnosis of Crohn's disease, microscopic colitis or indeterminate colitis
* Presence of ileostomy or colostomy, or history of prior colon resection
* Patients with planned hospitalization or surgery during the course of the study
* Known allergy to milk proteins, red meat or cornstarch
* Stools positive for enteric infection, including parasitic, or C. difficile toxin within 28 days of screening
* Documented presence of Hetatitis B (HBsAg), Hepatitis C (HCV), or HIV
* Presence of dysplasia of any grade on colonoscopic biopsies
* Treatment for cancer (excluding non-melanomatous cancer of the skin or cervical carcinoma in situ) or lymphoproliferative disorder (including lymphoma) within 5 years
* History of tuberculosis (TB) or Listeria infection, or known exposure to another person with active TB disease within 12 weeks of screening; or history of past or current infection with different opportunistic infections
* History of TNF inhibitor (infliximab, adalimumab or certolizumab pegol) use with primary treatment failure. Secondary treatment failures due to intolerance, allergic reaction, or loss of response will not constitute a basis for exclusion. Oral immunosuppressives, mesalamine, and corticosteroids (up to 20mg of prednisone per day) will be permitted so long as these medications are stable for defined periods of time before study participation commences.

Answer: B