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

December 13, 2022 updated by: University Hospital, Montpellier

Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF Agents in the Management of Patients With Inflammatory Bowel Disease Treated With Anti-TNFalpha Biotherapy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be recruited in 13 french centers and randomized in 2 groups with or without drug and ADAbs monitoring.

Anti-TNF inhibitors and ADAbs will be simultaneously measured in the patients serum by ELISA (LisaTracker - Theradiag) at weeks 6 and 24, months 4, 8, 12, 16, 20 and 24.

In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician.

In the monitored group, in case of loss of response the clinician will use immunomonitoring data to adapt the treatment following a simple treatment algorithm:

  • loss of response with therapeutic serum trough level of anti-TNF switch to another biologic
  • loss of response with subtherapeutic serum trough level of anti-TNF but without detectable ADAbs increase doses and/or shorten interval between infusions
  • loss of response with subtherapeutic serum trough level of anti-TNF and detectable ADAbs switch to another anti-TNF if inefficient switch to another biologic.

Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years:

  • primary outcome: Cost-utility analysis of the immunomonitoring strategy using incremental cost effectiveness ratio
  • secondary outcome: Evaluation of the quality of life (IBDQ score)

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with Crohn's disease or ulcerative colitis
  • Treated with anti-TNF

Exclusion Criteria:

  • anti-TNF contraindication
  • Previous treatment with anti-TNF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immuno monitoring
in case of loss of response, the clinician uses immunomonitoring data to adapt the treatment following a treatment algorithm.
Other: Immuno monitoring
treatment optimization
No Intervention: No immuno monitoring
in case of loss of response, immunomonitoring data are not transmit to the clinician who adapts the treatment with classical biological informations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost-utility analysis of the immunomonitoring strategy
Time Frame: 2 years
incremental cost-effectiveness ratio
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 2 years
IBDQ score
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Department of the medical information of Montpellier

Investigators

  • Principal Investigator: Thierry VINCENT, MD, PhD, Department of immunology in Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2015

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimate)

July 24, 2015

Study Record Updates

Last Update Posted (Estimate)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 9535

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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