Addition of Azathioprine in IBD Patients With Immunogenic Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-23

Study Completion Date

2020-06-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative Colitis

NCT03101800

Colitis, Ulcerative Colitis Ulcerative Exacerbation

UNKNOWN PHASE3

Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases

NCT03370601

Inflammatory Bowel Diseases

TERMINATED NA

Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease

NCT05599347

Crohn's Disease Relapse Biological Substance; Adverse Effect

RECRUITING PHASE2

Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence.

NCT02247258

Crohn Disease Recurrence Azathioprine +1 more

TERMINATED PHASE2

The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD

NCT03393247

Crohn Disease

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of the study in these patients with an immune mediated pharmacokinetic failure was to compare two strategies:

Switch to a second anti-TNF alone or switch to a second anti-TNF with addition of azathioprine

Comparing rates of clinical failure, rates of immunogenic failure and finally adverse events during a follow-up of 24 months

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clinical Failure After Switch

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two strategies

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open label study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

switch to anti-TNF alone

Switch to the second anti-TNF drug alone (infliximab or adalimumab)

Loss of response under Infliximab: 10 mg/kg IV every 8 weeks Randomization to: Adalimumab: induction 160/80 mg SC and Maintenance 40 mg EOW SC OR Loss of response under Adalimumab: 40mg EW SC Randomization to: Infliximab: 5mg/kg IV at W0, W2, W6 and every 8 weeks.

Group Type OTHER

Switch to a second anti-TNF drug alone

Intervention Type DRUG

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

switch to anti-TNF with addition of azathioprine

Switch to anti-TNF (infliximab or adalimumab) with addition of azathioprine

Loss of response under Infliximab: 10 mg/kg IV every 8 weeks Randomization to: Adalimumab: induction 160/80 mg SC and Maintenance 40 mg EOW SC with azathioprine 2.5 mg/kg/day OR

Loss of response under Adalimumab: 40mg EW SC Randomization to:

Infliximab: 5mg/kg IV at W0, W2, W6 and every 8 weeks with azathioprine 2.5 mg/kg/day.

Group Type OTHER

addition of azathioprine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

addition of azathioprine

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

Intervention Type DRUG

Switch to a second anti-TNF drug alone

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* IBD Patients in clinical failure under anti-TNF (Infliximab (IFX) or Adalimumab (ADA) in monotherapy at the optimal dose) ADA: 40mg/7 days, IFX: 10mg/kg/8 weeks Active disease CD: HBI \> 5 with Calprotectin \> 250 µg/g stool UC: Total Mayo Score \> 4 with an endoscopic subscore \> 1 Anti-TNF monotherapy for at least 4 months and optimization for at least two months
* Patients with an immune mediated PK failure Undetectable rates of anti-TNF and high Ab against anti-TNFs \> 20ng/mL for ATI and AAA (Elisa Theradiag) on two consecutive samples
* Patients who have agreed to and signed the consent form

Exclusion Criteria

* Unclassified colitis
* Pregnant woman
* Crohn's disease CD with a exclusive anoperineal phenotype
* Contraindication or intolerance to azathioprine
* Primary non-responder patients To the first anti-TNF or After the switch to a - second anti-TNF
* Ostomy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No