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Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases

NCT02508012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-09-30

No results posted yet for this study

Summary

Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD). However, more than one-third of patients present primary resistance, and one more third become resistant over time. One of the main factors associated with loss of response is the immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the serum and decrease its therapeutic activity. In this study the investigators propose a medico-economic evaluation of the measurement of anti-TNF agents and anti-drug antibodies serum concentrations in the management of patients with inflammatory bowel disease treated with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring. In the monitored group, in case of loss of response, the clinician will use biological informations to adapt the treatment following a simple treatment algorithm. In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician. Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years.

Conditions

Interventions

OTHER

Immuno monitoring

treatment optimization

Sponsors & Collaborators

  • Department of the medical information of Montpellier

    collaborator UNKNOWN

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Thierry VINCENT, MD, PhD · Department of immunology in Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-24
Primary Completion
2020-01-01
Completion
2020-01-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT02508012 on ClinicalTrials.gov