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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT03123120
Eligibility Criteria:
Inclusion Criteria
* 18 - 75 years at screening and randomisation
* Diagnosis of ulcerative colitis \>= 5 months prior to screening
* Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for \>= 4 months (Infliximab) or \>= 2 Monaten (Adalimumab or Golimumab) prior to randomisation
* Mild or moderate disease activity, defined as total Mayo Score (MCS) (\<= 10)
* Further inclusion criteria apply
Exclusion Criteria:
* Prior use of more than two different TNF inhibitors or vedolizumab
* Extensive colonic resection
* Evidence of infection with C. difficile or other intestinal pathogen \<28 days prior to screening
* Active or latent tuberculosis
* Further exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03123120
Study Brief:
Protocol Section:
NCT03123120