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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT05986903
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of inflammatory bowel disease according to ECCO criteria.
* Older than 18 years
* Subjects naïve to biological treatment
* Anti-TNF treatment initiation (infliximab or adalimumab) due to intestinal activity and/or perianal disease.
* Avaibility to evaluate HLA DQA1\*05 status
* Proactive therapeutic drug monitoring of anti-TNF levels
Exclusion Criteria:
* Initiation of anti-TNF treatment as prevention of post-surgical recurrence in Crohn's disease during the first 12 months after surgery or, afterwards, if endoscopic recurrence with a Rutgeerts 0-1.
* Initiation of anti-TNF treatment under combo treatment with immunomodulator. Prior initiation of immunomodulator or prior use and suspension would not be a contraindication.
* Initiation of anti-TNF treatment due to extraintestinal activity.
* Initiation of anti-TNF treatment by a non-gastroenterologist specialist.
* Initiation of anti-TNF treatment during pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05986903
Study Brief:
Protocol Section:
NCT05986903