Back to results

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

Primary Purpose

Crohn Disease

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Immunomonitoring-based follow-up

Standard follow-up

About this trial

This is an interventional other trial for Crohn Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 ...)

Sites / Locations

CHU de MontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immunomonitoring-based follow-up

Standard follow-up

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of patients with clinical recurrence

Evaluation of the clinical recurrence after surgery . Evaluation based on the CDAI. (clinical recurrence if CDAI ≥ 220 and ≥70 points increase from baseline CDAI), CRP (> 10mg/L) and fecal calprotectin (> 100μg/ g).

Percentage of patients with biological recurrence

Biological recurrence will be evaluated based on CRP and fecal calprotectin: CRP: 10 mg / L threshold to define a biological recurrence. Fecal Calprotectin: 100 μg / g threshold to define a biological recurrence

Percentage of patients with adverse effects

The practitioner will assess (through a questionnaire) the presence or absence : of joint pain, allergic reactions, autoimmune reaction, complications at the puncture wound, infections, hospitalization .

Rate of adalimumab in the serum

Adalimumab levels (in μg/mL) will be measured on a blood sample

Rate of anti-adalimumab antibodies in the serum

Anti-adalimumab antibodies (ng/mL) will be measured on a blood sample only in cases of undetectable adalimumabemia (Elisa Drug-sensitive technique)

Full Information

NCT ID

NCT04200547

First Posted

December 12, 2019

Last Updated

October 5, 2022

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT04200547

Brief Title

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

Acronym

ADAPT

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 29, 2020 (Actual)

Primary Completion Date

January 29, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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").

Masking

Outcomes Assessor

Masking Description

An endoscopy will be performed on patients of all groups 6 months after the surgery. Endoscopic results will be measured blindly by one assessor.

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immunomonitoring-based follow-up

Arm Type

Experimental

Arm 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.

Arm Title

Standard follow-up

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Immunomonitoring-based follow-up

Intervention 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. 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

Intervention Name(s)

Standard follow-up

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of patients with a Rutgeerts score ≥ i2

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Percentage of patients with clinical recurrence

Description

Time Frame

3 and 6 months

Title

Percentage of patients with biological recurrence

Description

Time Frame

3 and 6 months

Title

Percentage of patients with adverse effects

Description

Time Frame

3 and 6 months

Title

Rate of adalimumab in the serum

Description

Adalimumab levels (in μg/mL) will be measured on a blood sample

Time Frame

1, 3, and 6 months

Title

Rate of anti-adalimumab antibodies in the serum

Description

Anti-adalimumab antibodies (ng/mL) will be measured on a blood sample only in cases of undetectable adalimumabemia (Elisa Drug-sensitive technique)

Time Frame

1, 3, and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 ...)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lucile BOIVINEAU

Phone

+33 467337064

l-boivineau@chu-montpellier.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lucile BOIVINEAU

Organizational Affiliation

Montpellier University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Montpellier

City

Montpellier

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mégane BOIXIERE

Phone

+33467330165

First Name & Middle Initial & Last Name & Degree

Lucile BOIVINEAU

First Name & Middle Initial & Last Name & Degree

Romain ALTWEGG

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs