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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Unknown status

CT.gov ID

NCT02508012

Collaborator

Department of the medical information of Montpellier (Other)

260

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease Ulcerative Colitis	Other: Immuno monitoring	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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.

Actual Study Start Date :

Sep 24, 2015

Anticipated Primary Completion Date :

Sep 23, 2020

Anticipated Study Completion Date :

Jun 23, 2021

Arms and Interventions

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.

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.