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:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT00984568
Eligibility Criteria:
Inclusion Criteria:
* Any race or ethnicity
* Must have a diagnosis of moderate-to-severe active ulcerative colitis (UC) with inflammation present beyond the rectum and including more than 20 cm of the colon (Mayo score of 6 to 12 points, inclusive ≥ 2 in the endoscopy subscore)
* Must have responded inadequately to oral (with or without topical) 5-ASA treatment (prerequisite oral: at a minimum 4 g/d for 7 days) and must be considered for the first course of systemic corticosteroids; Participants with a UC and a Mayo score of ≥ 9 are also eligible without prior 5-ASA treatment
* Must agree to use acceptable methods of contraception for at least 2 weeks prior to starting any study treatment and to continue until at least 6 months after the last doses of study drugs
* Laboratory results must be within specified limits
* Must be negative for colorectal cancer or any associated lesions
* Must have a negative tuberculosis (TB) test
* Must have a chest x-ray within the 3 months with no clinically significant abnormality, or evidence of current active TB or latent TB
* Must have a negative stool culture
Exclusion Criteria:
* Pregnant, nursing, or planning pregnancy
* Had received previous treatment for UC with the corticosteroids, infliximab, azathioprine/
6-mercaptopurine (6-MP), cyclosporine, tacrolimus, methotrexate, sirolimus, mycophenolate, any tumor necrosis factor-alpha (TNF-α) inhibitor or receptor constructs that bind to ΤΝF-α (e.g., etanercept or adalimumab) and any other biologic agents
* Frequent (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
* Use of laxatives or any murine recombinant product
* Had surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage in previous 2 months
* History of colonic obstruction within the previous 6 months
* History of mucosal dysplasia, fistula or colonic resection, adenomatous polyps or stoma, severe, fixed symptomatic stenosis of the large or small intestine
* Had serious infection with previous 2 months, including human immunodeficiency virus (HIV) and hepatitis
* Had organ transplant (with the exception of a corneal transplant)
* Any malignancy within 5 years, including lymphoma
* History of demyelinating disease such as multiple sclerosis or optic neuritis
* Presence or history of congestive heart failure
* Requires chronic and frequent use of antimotility agents for control of diarrhea
* Requires total parenteral nutrition
* Had participated in any other clinical trial within 30 days or intention to participate in another clinical trial during participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00984568
Study Brief:
Protocol Section:
NCT00984568