Clinical Failure After Switch
Conditions
Brief 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.
Detailed description
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
Interventions
DRUGaddition of azathioprine
impact of addition of azathioprine after a switch of a second anti-TNF agent
DRUGSwitch to a second anti-TNF drug alone
Switch to a second anti-TNF drug alone without addition of azathioprine
Sponsors
Védrines, Philippe, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
open label study
Intervention model description
two strategies
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical failure | 24 months | clinical relapse or serious adverse event requiring stopping treatment during follow up |
Countries
France
Contacts
Primary Contactphilippe vedrines, MD,PhD
Backup Contactxavier roblin, MD,PhD
Outcome results
None listed