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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02148718
Eligibility Criteria:
Inclusion Criteria:
* Crohn's disease (CD) diagnosed within, at least, the previous 4 months.
* Patients with active luminal (Harvey-Bradshaw Index \[HBI\] ≥ 8) moderate to- severe CD.
* No response to a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant.
* If receiving any of the following treatments, their dose should be stable during the periods indicated:
* Aminosalicylates for, at least, the last 4 weeks
* Probiotics for, at least, the last 4 weeks
* Analgesics for, at least, the last 4 weeks
* Antidiarrheals for, at least, the last 4 weeks
* CD-related antibiotics for, at least, the last 4 weeks
* Azathioprine, 6-mercaptopurine or methotrexate for, at least, the last 12 weeks
* If receiving any of the following treatments, their dose should not have been increase in the past two weeks (the dose reduction is permitted):
* Oral budesonide (maximum dose of 9 mg/day)
* Oral prednisone or equivalent (maximum dose of 40mg/day)
Exclusion Criteria:
* Previous treatment with any anti-Tumor Necrosis Factor agent
* Surgical bowel resection within the previous 6 months, ostomy, extensive bowel resection (\> 100 cm), short bowel syndrome
* Fistulising Crohn's disease
* Treatment with cyclosporine or tacrolimus within the previous 8 weeks
* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure of worse than grade II New York criteria (New York Heart Association Functional Classification).
* Subject with an ostomy or ileoanal pouch, proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis (Subjects with a previous ileo-rectal anastomosis are not excluded).
* Screening laboratory values (according to central laboratory)
* Known hepatitis C (HC) infection.
* Serologic evidence of hepatitis B (HB) infection based on the results of testing for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc) and hepatitis B surface antibody (anti-HBs) antibodies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02148718
Study Brief:
Protocol Section:
NCT02148718