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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT07102368
Eligibility Criteria:
Inclusion Criteria:
1. Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics
2. Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements
3. By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study
Exclusion Criteria:
1. Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy
2. Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included
3. Has had a colectomy and/or a pouch
4. Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \& Johnson (J\&J)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07102368
Study Brief:
Protocol Section:
NCT07102368