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

University Hospital Center (CHU)

Status: Terminated

Conditions: Crohn Disease

Treatments: Other: Immunomonitoring-based follow-up; Other: Standard follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT04200547

RECHMPL19_0071

UF 7772 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Patients in the experimental arm will have a post-operative follow-up based on the immunomonitoring of serum levels of adalimumab. After ileocolic resection surgery, patients will have a therapeutic optimization of their adalimumab (Humira® or biosimilar) treatment, based on their serum residual rate of adalimumab.

Patients in the control group will receive a standard post-operative follow-up, which is based on clinical and biological recurrence.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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
• Concomitant participation of the patient in another research involving the human person.
• Patient not affiliated to the social security system (Article L.1121-11).
• Patient unable to sign the consent form
• 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 ...)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Immunomonitoring-based follow-up

Experimental group

Description:

Post-operative follow-up of Crohn's disease patients will be done through the measurement of the residual rate of the drug adalimumab in the serum.

Treatment:

Other: Immunomonitoring-based follow-up

Standard follow-up

Active Comparator group

Description:

Post-operative follow-up of Crohn's disease patients will be based on clinical and biological parameters. This strategy is the standard strategy for post-operative follow-up of Crohn's disease patients.

Treatment:

Other: Standard follow-up