Study of Cimzia for the Treatment of Ulcerative Colitis (UC CIMZIA)

Inclusion Criteria:

1. Adults aged 18-75 years
2. Established diagnosis of UC (by routine clinical, radiologic, endoscopic, and histologic criteria) of at least 3 months duration
3. Moderate to severe active disease, defined by Mayo score > 6 with endoscopic subscore > 2
4. Ability to understand the study protocol and treatments, willingness to comply with all study requirements, and ability to provide informed consent
5. No history of prior tuberculosis TB), no signs or symptoms of active TB, and negative Quantiferon gold test and chest X-ray showing no active or latent TB at screening
6. Screening blood tests must meet the following criteria: white blood cell count > 3000/µL (with neutrophils > 1500/µL and lymphocytes > 500/µL), hemoglobin > 8 g/dL, platelet count > 100,000/µL, liver function tests < 3 times the upper limit of normal, serum creatine < 1.5 mg/dL
7. Screening stool sample negative for Clostridium difficile, ova & parasites, and aerobic pathogens, including Aeromonas, Plesiomonas, Salmonella, Shigella, Yersinia, Campylobacter, and E. coli spp.

8. Medication use must meet the following criteria:

   1. Rectally administered topical 5-aminosalicylates (5-ASAs)/corticosteroids: must be discontinued by 1 month prior to screening; not allowed during the study
   2. Oral 5-ASAs: allowed if at stable dose for at least 2 weeks prior to screening; can remain on this stable dose during the study
   3. Antibiotics for UC: must be discontinued by 1 month prior to screening; not allowed during the study
   4. Antidiarrheals: must be discontinued by 2 weeks prior to screening; not allowed during the study
   5. Corticosteroids: allowed if at Prednisone dose equivalent of 20 mg/d or less, stable for 2 weeks prior to screening (dose/taper during study discussed below); budesonide is allowed at a dose less than or equal to 9 mg/day if at stable dose for 2 weeks prior to screening
   6. 6-Mercaptopurine (6MP)/Azathioprine/Methotrexate: allowed if on for at least 8 weeks, at stable dose for at least 4 weeks prior to screening; can remain on this stable dose during the study
   7. Anti-TNF therapy: patients must be naive to CZP; patients must be either naive to anti-TNF therapy or have lost response or become intolerant to at most one prior anti-TNF medication (infliximab or adalimumab, but not both) and must have been off their prior anti-TNF medication for at least 8 weeks prior to screening; primary nonresponders to anti-TNF therapy are excluded from the study
   8. Cyclosporine: patients previously receiving Cyclosporine for UC are excluded from the study
   9. Any other or investigational medications: must be discontinued at least 1 month or 5 half-lives (whichever is longer) before screening; not allowed during the study

Exclusion Criteria:

1. Diagnosis of Crohn's disease or indeterminate colitis, or clinical findings suggestive of Crohn's disease
2. Fulminant disease, toxic megacolon, or anticipated imminent colectomy
3. Presence of ileal pouch or ostomy
4. Pregnancy, desire to become pregnant during the following 18 months, or breast feeding
5. Surgery of any kind within 2 months of screening or anticipated surgery of any kind during the study
6. Anticipated imminent hospitalization for any medical conditions
7. Active ongoing infection of any kind
8. Current use of total parenteral nutrition

9. History of:

   1. Congestive heart failure or significant coronary artery disease (including myocardial infarction, percutaneous coronary intervention, or coronary artery bypass within 6 months of screening)
   2. Cancer
   3. Colonic dysplasia (except sporadic adenomas)
   4. HIV, chronic or active hepatitis B or C, or patients considered at high risk for these infections
   5. Prior opportunistic infection within 6 months of screening or prior opportunistic infection while on other anti-TNF therapy
   6. Hepatic disease (cirrhosis, chronic active hepatitis, or LFT abnormalities as above)
   7. Renal insufficiency (see above)
   8. Clinically important pulmonary disease (as determined subjectively)
   9. Demyelinating disease
   10. Organ transplantation, including bone marrow (except corneal)