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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT07100093
Eligibility Criteria:
Inclusion Criteria:
* Patients with an established diagnosis of CD according to standard criteria (clinical, analytical, endoscopic, radiological, and/or histological) with inflammatory activity, who begin treatment with ustekinumab for remission induction. Activity will be considered to be the presence of clinical activity (Harvey-Bradshaw index ≥5) and/or elevated fecal calprotectin (≥ 250μg/g; ≥100 in cases of surgically treated CD) and/or the presence of endoscopic activity (SES-CD ≥3).
* Patients with a confirmed diagnosis of CD according to standard criteria (clinical, analytical, endoscopic, radiological, and/or histological) undergoing stable maintenance treatment with ustekinumab for at least 6 months.
Exclusion Criteria:
* Patients in whom ustekinumab is indicated for the prevention of post-surgical recurrence.
* Patients in whom ustekinumab is indicated for the control of perianal disease.
* Patients in whom ustekinumab is indicated for the control of extraintestinal manifestations.
* Pregnant women.
* Patients who are unable to understand the nature of the study, the procedures to be followed, or who are not able to sign an informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07100093
Study Brief:
Protocol Section:
NCT07100093