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 @ 7:03 PM
Ignite Modification Date:
2025-12-24 @ 7:03 PM
NCT ID:
NCT01388257
Eligibility Criteria:
Inclusion Criteria:
* male or female 18 years or older,
* women of childbearing age who use an effective contraception method or women incapable of becoming pregnant \[(i.e. postmenopausal women for 1 year or surgically sterile (hysterectomy and/or bilateral oophorectomy)\],
* Patient with fistulizing anoperineal Crohn's disease. Anoperineal fistulas can be associated with ileal, colic or rectal lesions,
* Patient with at least 1 anoperineal fistula drained with a seton for more than 1 month,
* Patient treated with adalimumab for more than 1 month,
* Patient who agrees to undergo surgery for its drained fistula(s),
* Patient with immunosuppressive therapy (azathioprine, 6-mercaptopurine ou methotrexate) stable for at least 3 months or patients without immunosuppressive therapy,
* Patient who gave signed written informed consent after having received verbal explanation and written information related to the trial.
Exclusion Criteria:
* Pregnant or breastfeeding women,
* Patient having a perineal abscess,
* Patient with a high anovaginal fistula that cannot be treated, according to the investigator ,with fistulotomy, gluing, biodegradable plug or advancement flap,
* Patient treated with a daily dose of corticosteroids of more than 20 mg (a dose of more than 20 mg daily will be authorized during the study),
* Contraindication to proctological surgery on the drained fistula(s),
* Patient presenting with somatic or psychic signs or symptoms that are not compatible with his/her participation in the trial according to the investigator,
* Patient who participate in another clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01388257
Study Brief:
Protocol Section:
NCT01388257