Comparing Vedolizumab and Adalimumab for Crohn's Disease Treatment
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: A Randomized, Multicentre, Controlled Trial
This study is testing whether switching to Vedolizumab or increasing the dose of Adalimumab works better for people with Crohn's disease who aren't responding to their current Adalimumab treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Drugs / interventions | Adalimumab, vedolizumab, ustekinumab, infliximab |
| Locations | 12 sites (Le Kremlin-Bicêtre, PARIS and 11 other locations) |
| Trial ID | NCT06180382 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with Crohn's disease who initially responded to Adalimumab but are experiencing a loss of response while maintaining therapeutic drug levels.
Not a fit: Patients who have previously used Vedolizumab or Ustekinumab for Crohn's disease or those with certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment strategy for Crohn's disease patients experiencing loss of response to Adalimumab.
How similar studies have performed: Previous studies have shown that switching to another class of medication can be beneficial for patients with secondary loss of response, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Le Kremlin-Bicêtre, PARIS and 11 other locations
- 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)
- Hôpital de l'Archet II — Nice, France (Recruiting)
- Assistance Publique - Hôpitaux de Paris — Paris, France (Recruiting)
- CHU Bordeaux — Pessac, France (Recruiting)
- Ch Lyon Sud — Pierre-Bénite, France (Recruiting)
- CHU Rennes — Rennes, France (Recruiting)
- CHU de Saint-Etienne — Saint-Etienne, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.