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 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT04818892
Eligibility Criteria:
Inclusion Criteria:
For mRNA cohort:
* Participant has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
* On one of the following treatment regimens:
* Group A: Non-systemic immunosuppressive Group at least 75 participants
* Mesalamine monotherapy or no therapy for IBD
* Vedolizumab Therapy Group: on either vedolizumab monotherapy or combination therapy with methotrexate or azathioprine
* Group B: Systemic immunosuppressive Group at least 75 participants
* Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
* Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
* Anti-TNF Combination Therapy Group: on anti-TNF therapy as described above along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
* Ustekinumab Therapy Group: on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
* Tofacitinib Therapy Group: on tofacitinib at least 5mg PO BID
* Corticosteroid Therapy Group: on any one of the systemic immunosuppressive groups and any dose of corticosteroids
* Participant has been on the same IBD treatment for at least two months.
* Participant is receiving an mRNA COVID-19 vaccine per standard of care recommended by their clinical provider or has started the COVID-19 series or finished the mRNA COVID-19 vaccine series within the past six months and would qualify for six month study visits or has received a third dose of the vaccine as standard of care.
* Participants entering in the study at the six month study visit must have been on same treatment at their time of immunization.
For Viral vector cohort:
* Participant has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
* On one of the following treatment regimens:
* Group A: Non-systemic immunosuppressive Group at least 15 participants
* Mesalamine monotherapy or no therapy for IBD
* Vedolizumab Therapy Group: on vedolizumab monotherapy
* Group B: Systemic immunosuppressive Group at least 15 participants
* Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
* Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
* Anti-TNF Combination Therapy Group: on anti-TNF therapy as described above along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
* Ustekinumab Therapy Group: on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
* Tofacitinib Therapy Group: on tofacitinib at least 5mg PO BID
* Corticosteroid Therapy Group: on any one of the systemic immunosuppressive groups and any dose of corticosteroids
* Participant has been on the same IBD treatment for at least two months.
* Participant is receiving a viral vector COVID-19 vaccine per standard of care or has started or finished the viral vector series within the past 6 months. If participant entering at six months and would qualify for six month study visits and has received an additional one or two dose of viral vector of mRNA for a total of two -three COVID vaccines as standard of care.
* Participants entering in the study at the six month study visit must have been on same treatment at their time of immunization.
Exclusion Criteria:
For mRNA cohort:
* Allergy to COVID-19 vaccine or a component of it
* Participant cannot or will not provide written informed consent
* Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity
For Viral vector cohort:
* Allergy to COVID-19 vaccine or a component of it
* Participant cannot or will not provide written informed consent.
* Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04818892
Study Brief:
Protocol Section:
NCT04818892