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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT05584735
Eligibility Criteria:
Inclusion Criteria:
* A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria
* Currently one of the following groups:
1. Group A: Anti-TNF Therapy Group
* Maintenance monotherapy: infliximab (at least every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
* Combination Therapy: Anti-TNF Combination Therapy Group on anti-TNF therapy as described above along with either methotrexate, azathioprine, or 6MP
2. Group B: Non-TNG biologic
* Ustekinumab Therapy: on either ustekinumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
* Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
* Risankizumab Therapy: 360mg at least every 8 weeks
3. Group C: Janus Kinase Therapy
* Tofacitinib Therapy: at least 5mg PO BID
* Upadactinib Therapy: at least 15mg PO daily
* Patient has been on stable treatment for IBD for at least three months
* Must be able to provide research samples between 28-65 days post influenza or Covid-19 vaccination.
Exclusion Criteria:
* Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)
* Recent oral antibiotics within previous 2 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05584735
Study Brief:
Protocol Section:
NCT05584735