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

NCT04200547 | Terminated

• 2 other identifiers: RECHMPL19_0071UF 7772
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a Rutgeerts score ≥ i2

  The primary endpoint will be measured by ileocolonoscopy under general anesthesia after standard preparation by PEG with video recording of the examination, carried out by one of the investigators of the study in each center. An ileocolonoscopy 6 months after intestinal resection remains the reference examination for the endoscopic diagnosis of recurrence according to the endoscopic Rutgeerts score (endoscopic recurrence if Rutgeerts score ≥ i2) and allows the adaptation or the introduction of a treatment to limit clinical recurrence at 18 months.

  6 months

Secondary Outcomes (5)

• Percentage of patients with clinical recurrence

  3 and 6 months

• Percentage of patients with biological recurrence

  3 and 6 months

• Percentage of patients with adverse effects

  3 and 6 months

• Rate of adalimumab in the serum

  1, 3, and 6 months

• Rate of anti-adalimumab antibodies in the serum

  1, 3, and 6 months

Study Arms (2)

Immunomonitoring-based follow-up

EXPERIMENTAL

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.

Other: Immunomonitoring-based follow-up

Standard follow-up

ACTIVE COMPARATOR

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.

Other: Standard follow-up

Interventions

Immunomonitoring-based follow-up 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.

Immunomonitoring-based follow-up

Standard follow-up 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.

Standard follow-up

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ...)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Lucile BOIVINEAU

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An endoscopy will be performed on patients of all groups 6 months after the surgery. Endoscopic results will be measured blindly by one assessor.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, interregional, open-label, prospective comparative PHASE III, randomized with a ratio (1:1), with 2 parallel groups (experimental group called "immunomonitoring" and control group called "standard strategy based on clinical and biological activity").

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: January 29, 2020
• Primary Completion: June 29, 2024
• Study Completion: June 29, 2024
• Last Updated: January 21, 2025

Record last verified: 2025-01

Locations

FR (1)