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

NCT04200547 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-01-21

No results posted yet for this study

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

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Lucile BOIVINEAU · Montpellier University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2024-06-29
Completion
2024-06-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200547 on ClinicalTrials.gov