Comparing Vedolizumab and Adalimumab for Crohn's Disease Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of Vedolizumab compared to intensifying the dose of Adalimumab in patients with Crohn's disease who have lost response to Adalimumab despite having therapeutic drug levels. The study aims to determine the best intervention strategy for these patients by assessing drug levels and antibodies to guide treatment decisions. It involves a combination of therapeutic drug monitoring and clinical assessments to optimize patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).
* Patient affiliated to or entitled under a social security scheme

Exclusion Criteria:

* 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.

Where it's running

• APHP - Hôpital Bicêtre
  Le Kremlin-Bicêtre, Paris, France Recruiting
• CHU Amiens
  Amiens, France Recruiting
• CHRU Lille
  Lille, France Recruiting
• Chu Limoges
  Limoges, France Recruiting
• Aphm
  Marseille, France Recruiting
• CHU Montpellier
  Montpellier, France Recruiting

Study contacts

• Principal investigator: Mathilde BARRAU, MD — CHU de Saint-Etienne
• Study coordinator: Mathilde BARRAU, MD
• Email: mathilde.barrau@chu-st-etienne.fr
• Phone: (0)477829626

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating Vedolizumab for treating moderate to severe Crohn's Disease in adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.