• About Ulcerative Colitis Disease

Ulcerative colitis is a chronic inflammatory condition of the colon and is characterized by mucosal ulceration, rectal bleeding, diarrhea, abdominal pain and may be complicated by severe bloody diarrhea and toxic megacolon, requiring major and sometimes urgent surgery. An estimated 900,000 people suffer from ulcerative colitis in the United States and Western Europe with 45 percent of UC cases diagnosed in people ages 15-44 in the United States.

Ulcerative colitis (UC) is a chronic inflammatory condition of the colon with the potential for extraintestinal manifestations. UC is characterized by mucosal ulceration, rectal bleeding, diarrhea, and abdominal pain and may be complicated by severe bloody diarrhea and toxic megacolon, requiring major and sometimes urgent surgery. UC represents dysregulation of the mucosal immune system in genetically susceptible individuals in response to commensal microbiota and other environmental triggers. The overall incidence of UC ranges from 6.3 to 24.3 cases per 100,000 persons per year, and prevalence ranges from 4.9 to 505.0 cases per 100,000 persons, with the highest estimates in Western European and North American populations. Although the incidence and prevalence vary between regions of the world, both have been rising, which may be due in part to better detection and diagnosis, and Westernization of diet. The disease can affect any age group, but diagnosis peaks between the ages of 15 and 35 years.

Ref: http://www.roche.com/investors/ir_update/inv-update-2013-05-18.htm

• Patients must meet the following criteria for study entry:

* Able and willing to provide written informed consent
* 18 - 80 years of age, inclusive
* Diagnosis of UC established at least 6 months prior to Day1 by clinical and endoscopic
  evidence and corroborated by a histopathology report (Note: histopathology may be
  performed at screening, if no prior report is readily available.)
* Moderately to severely active UC as determined by an MCS of 6 - 12 with an endoscopic
  subscore  2 and a rectal bleeding subscore  1, within 14 days of Day 1
* Evidence of UC extending a minimum of 20 cm from the anal verge as determined by
  baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed within 14 days of
  Day 1
* Intolerant or refractory to one or two of the following TNF-inhibitors within the previous
  5 years as defined below:
    Signs and symptoms of persistently active disease despite a history of at least one
    4-week induction regimen of one or two of the following agents:
    Infliximab: 5 mg/kg IV, 2 doses at least 2 weeks apart
    Adalimumab: 160 mg SC dose followed by 80 mg dose at least 2 weeks apart
    Golimumab: 200 mg SC followed by a 100 mg dose at least 2 weeks apart
OR
Recurrence of symptoms during scheduled maintenance dosing following prior clinical
benefit (discontinuation despite clinical benefit does not qualify)
OR
History (within previous 5 years) of intolerance of at least one or two TNF-inhibitors
(including but not limited to infusion-related reaction, demyelination, congestive heart
failure, infection)
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