An interventional study of Immunomonitoring-based follow-up and Standard follow-up in Crohn Disease, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-21.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
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.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 42 is below the median of 66 across 1,212 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 226 are open to participants now.
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Indication of postoperative treatment for the prevention of recurrence of Crohn's disease (with at least 1 risk factor for recidivism):
Exclusion Criteria:
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
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
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.
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.
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.
Time frame: 6 months
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).
Time frame: 3 and 6 months
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
Time frame: 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 .
Time frame: 3 and 6 months
Rate of adalimumab in the serum
Adalimumab levels (in μg/mL) will be measured on a blood sample
Time frame: 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)
Time frame: 1, 3, and 6 months
Ran from Jan 2020 to primary completion in Jun 2024, 53 months.
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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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