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| ID | Type | Description | Link |
|---|---|---|---|
| UF 7772 | Other Identifier | UH Montpellier |
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The recruitment of participants was no longer sufficient to continue the study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 and 6 months |
| Percentage of patients with biological recurrence |
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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):
Written and signed consent by the participant and the investigator
Affiliated person or beneficiary of the social security system.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucile BOIVINEAU | Montpellier University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Montpellier | France |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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").
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An endoscopy will be performed on patients of all groups 6 months after the surgery. Endoscopic results will be measured blindly by one assessor.
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| 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. |
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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 |
| 3 and 6 months |
| 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 . | 3 and 6 months |
| Rate of adalimumab in the serum | Adalimumab levels (in μg/mL) will be measured on a blood sample | 1, 3, and 6 months |
| 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) | 1, 3, and 6 months |
| D007410 | Intestinal Diseases |