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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT02771457
Eligibility Criteria:
Inclusion Criteria:
* Subjects 18 years or older who are willing and able to provide informed consent
* HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date.
* History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician.
* Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals
* Infliximab drug holiday for at least 12 weeks.
Exclusion Criteria:
* Inability or unwillingness to provide informed consent
* Pregnant patients
* Prior history of serious infusion reaction to IFX
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02771457
Study Brief:
Protocol Section:
NCT02771457