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

NCT ID: NCT04200547

Last Updated: 2025-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-29
• Study Completion Date: 2024-06-29

Brief Summary

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.

Detailed 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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Immunomonitoring-based follow-up

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.

Group Type: EXPERIMENTAL

Immunomonitoring-based follow-up

Intervention Type: OTHER

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. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. 3 months after the surgery, serum levels of adalimumab will be measured:

• If the level is below 5ug/mL, adalimumab treatment will be increased to every other week until the end of the study.
• If adalimumab level in the serum is above 5ug/mL, the treatment's frequency will be maintained until the end of the study.

Standard follow-up

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.

Group Type: ACTIVE_COMPARATOR

Standard follow-up

Intervention Type: OTHER

Post-operative follow-up of Crohn's disease patients will be based on clinical and biological parameters. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. If clinical relapse (CDAI \> 220 together with an increase of 70 points) and biological relapse (CRP \> 10mg/mL and fecal calprotectin \> 100 ug/g) occur, frequency of adalimumab treatment will be increased to once a week.

Interventions

Immunomonitoring-based follow-up

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. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. 3 months after the surgery, serum levels of adalimumab will be measured:

• If the level is below 5ug/mL, adalimumab treatment will be increased to every other week until the end of the study.
• If adalimumab level in the serum is above 5ug/mL, the treatment's frequency will be maintained until the end of the study.

Intervention Type: OTHER

Standard follow-up

Post-operative follow-up of Crohn's disease patients will be based on clinical and biological parameters. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. If clinical relapse (CDAI \> 220 together with an increase of 70 points) and biological relapse (CRP \> 10mg/mL and fecal calprotectin \> 100 ug/g) occur, frequency of adalimumab treatment will be increased to once a week.

Intervention Type: OTHER

Eligibility Criteria

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 ...)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucile BOIVINEAU

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

CHU de Montpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL19_0071

Identifier Type: -

Identifier Source: org_study_id

UF 7772

Identifier Type: OTHER

Identifier Source: secondary_id