MedTrace Logo

Addition of Azathioprine in IBD Patients With Immunogenic Failure

NCT03580876 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-07-10

No results posted yet for this study

Summary

Loss of response under anti-TNF is frequent. 20% of patients with clinical relapse present an immune mediated pharmacokinetic failure. In the last AGA recommendations, switch to another anti-TNF drug is suggested with no indication of immunosuppressive agent. In a recent study, 70% of patients with an immunogenic failure to a first anti-TNF agent developed a new immunogenic failure to the second anti-TNF drug using alone.

Conditions

  • Clinical Failure After Switch

Interventions

DRUG

addition of azathioprine

impact of addition of azathioprine after a switch of a second anti-TNF agent

DRUG

Switch to a second anti-TNF drug alone

Switch to a second anti-TNF drug alone without addition of azathioprine

Sponsors & Collaborators

  • Védrines, Philippe, M.D.

    lead INDIV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2019-06-10
Completion
2020-06-10

Countries

  • France

More Related Trials

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 NCT03580876 on ClinicalTrials.gov