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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05813860
Eligibility Criteria:
Inclusion Criteria:
* Participants with Crohn's disease who meet the diagnostic criteria of the Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)
* Meet the indications for IFX use
* CDAI score of 220-450; ageā„18 years, regardless of gender
* Participants or family members able to understand the study protocol and willing to participate in this study by providing written informed consent
Exclusion Criteria:
* NUDT 15 CT and TT genotypes; previous treatment with IFX and/or other anti-TNF biologics
* Participants who are proposed to have given birth and/or breastfeeding in the 12 months
* those with immunosuppressive intolerance or contraindications
* concurrent chronic diseases or factors of other systems (including severe cardiopulmonary, hepatic and renal, neurological, psychiatric, rheumatic and immune diseases, alcoholism, drug dependence, other chronic active diseases and long-term hormonal or immunosuppressive drugs)
* Excluding infectious diseases (tuberculosis, etc.)
* Excluding tumor-related diseases (lymphoma, gastrointestinal tract tumors, etc.)
* any medical condition/combined surgery/medication/other clinically significant abnormal laboratory tests which, in the judgment of the investigator, may affect the results of the test
* Known refusal or inability to follow protocol requirements for any reason (including planned clinical visits and examinations)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05813860
Study Brief:
Protocol Section:
NCT05813860