Addition of Azathioprine in IBD Patients With Immunogenic Failure

• Status: Unknown status
• Trial end date: 2020-06-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Védrines, Philippe, M.D.
• Treatments: Azathioprine

Criteria

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