Interest of the Dosage of Adalimumab Serum Levels in Crohn's Disease Patients for Prevention of Postoperative Recurrence

Trial details

Who runs it

University Hospital, Montpellier

Trial code

NCT04200547

Record updated

21 January 2025

Original description

Study comparing 2 modalities of Crohn's disease patients postoperative follow-up treated with adalimumab (Humira® or biosimilar) : immunomonitoring of adalimumab serum levels versus standard follow-up, which is based on the clinical and biological activity of the disease.Read full original descriptionShow less

Prospective, Controlled, Randomized, Multicentered, Open-label Study, Comparing 2 Modalities of Follow-up of Patients With Crohn's Disease, Postoperatively Treated With Adalimumab (Immunomonitoring vs Standard Follow-up)

Study comparing 2 modalities of Crohn's disease patients postoperative follow-up treated with adalimumab (Humira® or biosimilar) : immunomonitoring of adalimumab serum levels versus standard follow-up, which is based on the clinical and biological activity of the disease.

Inclusion: Patient between the ages of 18 and 75; Use of an effective method of contraception during treatment with adalimumab for women of childbearing age; Crohn's disease diagnosed according to the criteria defined by the national and international recommendations for at least 3 months; IIeocolic resection with ileocolic anastomosis and absence of residual macroscopic lesion, or ileocolic resection with transient ostomy and restoration of continuity; For anti-TNF-naive patients: negative pre-anti TNF balance; Indication of postoperative treatment for the prevention of recurrence of Crohn's disease (with at least 1 risk factor for recidivism):; active smoking (≥ 1 cigarette / day at the time of surgery); hail resection> 50 cm; second intestinal resection; presence of anoperineal lesions; Penetrating impairment (B3 of the Montreal Classification); Biotherapy treatment for more than 6 months before the surgery; Written and signed consent by the participant and the investigator; Affiliated person or beneficiary of the social security system.

Exclusion: Concomitant participation of the patient in another research involving the human person; Immunized patients (with anti-adalimumab antibodies > 10ng / mL and undetectable adalimumab levels, Elisa drug sensitive technique used) for patients already treated with adalimumab (Humira® or biosimilar) before surgery; Patients in combination therapy with azathioprine, 6-mercaptopurine or methotrexate Post-operative, or treated by another biotherapy (infliximab, vedolizumab, ustekinumab ...); Intolerance or allergy to adalimumab (Humira® or biosimilar); Patients to whom adalimumab (Humira® or biosimilar) is contraindicated; Intestinal stoma without restoration of continuity; Pregnant woman (dosage of positive βHCG) or breastfeeding according to article L1121-5 of the french public health law; Contraindication or refusal of ileocolonoscopy at 6 months; Patient who could not be followed regularly for psychological, social or geographical reasons; Vulnerable people according to article L1121-6 of the french public health law; Persons subject to legal protection (guardianship, trusteeship) or unable to express their consent according to Article L1121-8 of the french public health law or under the protection of justice according to article L1122.2 of the CSP; Patient not affiliated to the social security system (Article L.1121-11); Patient unable to sign the consent form.

ClinicalTrials.gov NCT04200547