Status:
RECRUITING
Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration.
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Takeda France
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents mainten...
Detailed Description
To address these issues, for IFX or ADA therapy, several studies have proposed some algorithms according to which interventions are based on a combined assessment of IFX or ADA drug level and antibodi...
Eligibility Criteria
Inclusion
- Major patient and having given consent to participate in the study
- Patients with Crohn's disease who have responded primary to Adalimumab princeps or similar bio with loss of response to Adalimumab (40 mg every two weeks) with therapeutically adequate levels of ADA (\> 7.5 μg/mL).
- Patient affiliated to or entitled under a social security scheme
Exclusion
- Pregnant woman
- Patient unable to perform MRI or VCE or ileocolonoscopy or ultrasound less than one month before inclusion
- Previous or current use of vedolizumab or ustekinumab for Crohn's disease or participation in a biological study
- Concomitant use of immunomodulators
- Patients on corticosteroid therapy
- History of cancer
- History of human immunodeficiency virus (HIV), immunodeficiency syndrome, central nervous system (CNS) demyelinating disease (including myelitis), neurological symptoms suggestive of demyelinating disease, chronic recurrent infection, active tuberculosis (received or untreated), severe infections such as sepsis and opportunistic infections
- Patient with ileoanal pouchitis or ileorectal anastomosis
- Patient with short small bowel syndrome as determined by investigator
- Patients receiving total parenteral nutrition (TPN)
- Patients receiving enteral nutrition
- Patient under legal protection or unable to give consent
- Hemorrhagic rectocolitis or indeterminate colitis
- Patients treated with concomitant immunosuppressive agents
- Patient treated with an optimized dose of adalimumab
- Primary non-responder to Adalimumab
- Patient previously treated with infliximab or ustekinumab before adalimumab
- Severe relapse defined by CDAI \> 330
- Patient with anoperineal Crohn's disease
- Crohn's disease patient with transient or permanent stoma.
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06180382
Start Date
October 31 2024
End Date
January 1 2027
Last Update
November 26 2025
Active Locations (12)
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1
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, Paris, France, 94270
2
CHU Amiens
Amiens, France, 80000
3
CHRU Lille
Lille, France, 59037
4
Chu Limoges
Limoges, France, 87000