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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT06636032
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years old,
* Patients who signed the informed consent,
* Patient affiliated to a social security system,
* Controlled luminal Crohn's disease characterized by an Harvey-Bradshaw score less or equal than 8 and diagnosed on clinical, endoscopic, histological and/or radiological criteria for more than 3 months,
* Colonoscopy less than a year old without ulcer in the rectum,
* Presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports,
* Patient treated with a combined treatment (drainage on setons + anti-TNFα) and who failed conventional treatment after 6 months and whose intraluminal disease (intestinal damage) is controlled
Exclusion Criteria:
* Refusal of the patient to participate in the study,
* Positive QuantiFERON test,
* Patient with transplanted organ,
* History of cancer in the last five years or lympho-proliferative disease,
* Persistent bacterial or viral infection,
* Patient with a contraindication to MRI,
* Known allergy to Gadolinium,
* Known allergy to Albumine,
* End-stage organ failure,
* Pregnant or breastfeeding women,
* Women of childbearing age without effective contraception throughout the duration of the study,
* Patient under judicial protection, under guardianship or curatorship.
* Patient previously treated with ALOFISEL®
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06636032
Study Brief:
Protocol Section:
NCT06636032