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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT05394805
Eligibility Criteria:
Inclusion Criteria:
* Participants meet the diagnosis of moderate to severe Crohn's disease.
* Participants prescribed with Humira, under investigators' sufficient consideration of benefits/ risks per local label.
Exclusion Criteria:
* Participants who have any of the contraindications as per adalimumab (Humira) label in China.
* Participants who are allergic to any component of adalimumab (Humira).
* Participants with active hepatitis B diagnosed.
* Participants with severe active infection, or known history of active or latent tuberculosis (TB), or latent TB infection with inadequate treatment.
* Participants with cancer diagnosed, excluding also those with non-melanoma skin cancer (NMSC) completely treated, per local label.
* Participants with moderate to severe heart failure.
* Participants who are unwilling to participate, or not suitable for participation as judged by the investigator at risk of noncompliance to study procedure.
* Participants who are enrolled to other interventional studies.
* Participants who are prescribed with adalimumab but choose Humira bio-similar in China.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05394805
Study Brief:
Protocol Section:
NCT05394805