Comparing vedolizumab with higher-dose adalimumab in Crohn's disease patients
Compares vedolizumab with higher-dose adalimumab in adults whose Crohn's disease stopped responding.
Key facts
- Who runs it
- Centre Hospitalier Universitaire de Saint Etienne
- Where
- Amiens Cedex 1, Creteil, La Roche Sur Yon Cedex 9, Le Kremlin-Bicetre, Lens, Lille, Limoges, Marseille, Montpellier Cedex 5, Nantes, Nice, Pessac, Pierre-Bénite, Rennes, SAINT HERBLAIN, Saint-Priest-en-Jarez, Toulouse Cedex 3, and Valence, FranceSee the 18 sites
- Trial code
- Registry title
- 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.
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 220 people, planned
- Started
- 31 Oct 2024
- Expected to end
- 31 Oct 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Adalimumab
- Vedolizumab
- Record updated
- 5 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Crohn's disease who first responded to adalimumab 40 mg every two weeks and then lost that response.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Crohn's disease with loss of response to adalimumab after a first response. Severe relapse (CDAI above 330) is not allowed.
- Earlier treatment
- Must have responded at first to adalimumab (original or similar biologic), 40 mg every two weeks, then lost response. Cannot have used vedolizumab or ustekinumab, or infliximab or ustekinumab before adalimumab.
Main reasons for not taking part
- Pregnancy
- Taking immunomodulators, other immunosuppressive drugs or corticosteroids
- History of cancer, HIV, active tuberculosis or severe infections
- Anal or perianal Crohn's disease, a stoma, or ileoanal pouchitis
- Already on an optimized adalimumab dose, or never responded to adalimumab
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 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
- Patients receiving total parenteral nutrition (TPN)
- Patients receiving enteral nutrition
- Patients treated with concomitant immunosuppressive agents
- Patient treated with an optimized dose of adalimumab
- Patient previously treated with infliximab or ustekinumab before adalimumab
- History of cancer
- Patient with short small bowel syndrome as determined by investigator
- Patient with anoperineal Crohn's disease
- Crohn's disease patient with transient or permanent stoma
- Pregnant woman
- Patient with ileoanal pouchitis or ileorectal anastomosis
- Patient under legal protection or unable to give consent
- Hemorrhagic rectocolitis or indeterminate colitis
- Primary non-responder to Adalimumab
- Severe relapse defined by CDAI > 330
Where in France
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranceTaking people
- Assistance Publique Hopitaux De ParisCreteil, FranceTaking people
- Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9, FranceTaking people
- Assistance Publique Hopitaux De ParisLe Kremlin-Bicetre, FranceTaking people
- Chorale Du Centre Hospitalier De LensLens, FranceTaking people
- Centre Hospitalier Universitaire de LilleLille, FranceTaking people
- Centre Hospitalier Et Universitaire de LimogesLimoges, FranceTaking people
- Assistance Publique Hôpitaux de MarseilleMarseille, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Clinique Jules VerneNantes, FranceTaking people
- Centre Hospitalier Universitaire de NiceNice, FranceTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
- Hospices Civils de LyonPierre-Bénite, FranceTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranceTaking people
- Clinique Privé Santé AtlantiqueSAINT HERBLAIN, FranceTaking people
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranceTaking people
- Clinique PasteurToulouse Cedex 3, FranceTaking people
- Centre Hospitalier ValenceValence, FranceTaking people
About the trial
What the trial wants to find out
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 maintenance therapy. The optimal intervention in patients with secondary loss-of-response (LOR) is still poorly defined, as there are still scant data on how best to choose the next intervention from among dose-intensification, switch to another anti-TNF or switch out of the anti-TNF class. Moreover, according to STRIDE 2 recommendations and CALM study, optimize patients based solely on lack of biological remission (CRP, calprotectin) can be discuss. If CALM study has showed that the intervention arm based on regular monitoring fecal calprotectin, CRP and/or CDAI to optimize patients under adalimumab was significantly associated to an increase rate of mucosal healing that the standard of care strategy based on only clinical activity, TDM was not available to guide drug optimization strategy.
The 2 groups in the trial
- Adalimumab with optimisationTreatment being tested
Patients with Crohn's disease will be included. They will have Adalimumab with optimisation as treatment.
Treatment: Adalimumab
- VedolizumabTreatment being tested
Patients with Crohn's disease will be included. They will have Vedolizumab as treatment.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Comparing vedolizumab with higher-dose adalimumab in Crohn's disease patientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 May 2026