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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT01349920
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of Crohn's Disease (CD) of at least 6 weeks duration, or acute diagnosis of sufficiently severe CD warranting initiation of infliximab sooner than allowed by fecal calprotectin turnaround time
* History of colonic involvement verified by prior endoscopy or radiography
* Indicated for treatment with infliximab according to current best medical practice
* Body Mass Index (BMI) between 15 kg/m\^2 and 35 kg/m\^2
* Women of childbearing potential and non-vasectomized men agree to use medically-acceptable contraception
* Negative pregnancy test
* No signs or symptoms of active tuberculosis (TB) and has a negative TB test within 6 weeks of first study drug administration
Exclusion Criteria:
* Pregnancy, intention to become pregnant, or breastfeeding
* Evidence of a colon unaffected by CD
* Indication for surgery
* Perianal disease likely to interfere with study participation
* Presence of a stoma or history of colectomy
* Symptomatic diarrhea unrelated to CD
* Strictures or evidence of bowel obstruction
* Presence of abscess unless completed definitive treatment can be documented one week prior to screening
* Presence of fistulas
* Contraindication to infliximab
* Intolerance to sedatives or other medications required for endoscopy
* Any prior use of anti-inflammatory biologic therapy
* Moderate or severe congestive heart failure
* History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis
* Major surgery or donation/loss of at least one unit of blood within 4 weeks of screening
* Positive for hepatitis B surface antigen, hepatitis C antibodies, or Human Immunodeficiency Virus (HIV)
* History of any tumor except adequately treated basal cell carcinoma or carcinoma in situ of the cervix
* History of systemic granulomatous infection
* History of nontuberculous mycobacterial disease, or any opportunistic infection within 12 months of study entry
* Transplanted organ including bone marrow or hematopoietic stem cell-derived marrow
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01349920
Study Brief:
Protocol Section:
NCT01349920