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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT02434133
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.
* Undergoing blood work the day of the study visit for routine blood monitoring due to medication.
* Has a documented tetanus-diphtheria (Td) or tetanus-diphtheria-acellular pertussis (Tdap) in the Wisconsin Immunization Registry (WIR) at least 4 weeks prior to entering study.
* Has a document measles, mumps and rubella (MMR) in the Wisconsin Immunization Registry (WIR) at least 4 weeks prior to entering study. This will need to be met by 50% of patient in group A-C.
* Is currently taking one of the following medication regimens for at least 3 months.
* Group A (Immunomodulator) currently taking azathioprine or 6- mercaptopurine
* Group B (Biologic group) currently taking anti-TNF therapy (infliximab, golimumab, adalimumab, or certolizumab).
* Group C (Combination therapy) currently taking anti-TNF therapy and an immunomodulator (including methotrexate)
* The patient must understand and voluntarily sign the informed consent document.
Exclusion Criteria
* Unconfirmed Td or Tdap vaccination status
* Patients in whom venipuncture are not feasible due to poor tolerability or lack of easy access.
CONTROLS Inclusion Criteria
* Has a documented tetanus-diphtheria (Td) or tetanus-diphtheria-acellular pertussis (Tdap) in the Wisconsin Immunization Registry (WIR) at least 4 weeks prior to entering study.
* Has a document measles, mumps and rubella (MMR) at least two injections in the Wisconsin Immunization Registry (WIR) at least 4 weeks prior to entering study.
CONTROLS Exclusion Criteria
* Currently on immunosuppressive therapy
* Has a chronic health condition that may have an impact on vaccine antibody concentrations as deemed by the investigators, including chronic liver disease, celiac disease, history of solid organ or bone marrow transplantation.
* Older than age 65 years
* Unconfirmed MMR vaccination status
* Patients in whom venipuncture are not feasible due to poor tolerability or lack of easy access.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02434133
Study Brief:
Protocol Section:
NCT02434133