Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT00616434
Eligibility Criteria:
Key Inclusion Criteria:
* Established diagnosis of ulcerative colitis (UC) for ≥6 months
* 20 cm active disease at Screening endoscopy
* Must have active UC with a Mayo Score/Disease Activity Index (DAI) of 6 to 13 points and moderate to severe disease on endoscopy (Mayo endoscopic score of at least 2) despite prior or concomitant treatment
* Colonoscopy within past 5 years for extent of disease and to exclude polyps
* For subjects with UC for more than 10 years, colonoscopy with appropriate biopsies within 1 year prior to Screening to exclude dysplasia and neoplasia.
* Must be willing and able to practice effective birth control during the study and for 1 month after the last dose of study treatment.
Key Exclusion Criteria:
* Diagnosis of indeterminate colitis or Crohn's disease
* Need for imminent surgery
* Diagnosis of primary sclerosing cholangitis or toxic megacolon
* Hemoglobin ≤9 g/dL
* White blood cell count \< 3500 cells/mm\^3
* Lymphocyte count \<1000 cells/µL
* Platelet count \<100,000 cells/µL
* Female subjects who are pregnant or who wish to become pregnant during the study, or who are lactating
* Known symptomatic colonic stricture
* Stool cultures positive for enteric infection
* History of malignant disease
* History of major abdominal surgery (e.g., gastrectomy) within past 5 years
* History of small bowel or colonic obstruction or resection
* History of drug or alcohol abuse (as defined by the Investigator) within 2 years prior to Screening
* Use of anti-diarrheal agents during the screening period
* Previous participation in this study
* Previous treatment with interferon beta or other interferon products
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00616434
Study Brief:
Protocol Section:
NCT00616434