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 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT02871635
Eligibility Criteria:
Inclusion criteria:
* Males and females aged \>=18 and =\<80 years at Screening who have a diagnosis of moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following:
* Crohn's Disease Activity Index (CDAI) score of \>=220 and =\<450
* A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening
* Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer(s) before randomization
* Anti-tumor necrosis factor (TNF) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria:
* Responded and developed secondary resistance due confirmed anti-infliximab anti-drug antibody formation, which caused infliximab depletion
* Responded and became intolerant
* Further inclusion criteria apply
Exclusion criteria:
* Patients with ulcerative colitis or indeterminate colitis
* Patients with symptomatic known obstructive strictures
* Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while enrolled in the trial
* Patients with an ostomy or ileoanal pouch
* Patients with short bowel syndrome
* Patients who have previously used infliximab and have never clinically responded
* Patients who have previously received treatment with adalimumab, or who have participated in an adalimumab or adalimumab biosimilar clinical trial
* Further exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02871635
Study Brief:
Protocol Section:
NCT02871635