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Study identifier: NCT06180382 Synced from ClinicalTrials.gov · July 29, 2026
● 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.

Condition: Crohn's Disease  ·  Sponsor: Centre Hospitalier Universitaire de Saint Etienne

PhasePhase 4
Planned participants220
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Mathilde BARRAU, MD  ·  (0)477829626  ·  mathilde.barrau@chu-st-etienne.fr

Sandra COURNIER, project manager  ·  (0)477127652  ·  sandra.cournier@chu-st-etienne.fr

Always discuss trial participation with your own doctor first.

Locations (12)

APHP - Hôpital BicêtreLe Kremlin-Bicêtre, PARIS, FranceRecruiting
CHU AmiensAmiens, FranceRecruiting
CHRU LilleLille, FranceRecruiting
Chu LimogesLimoges, FranceRecruiting
APHMMarseille, FranceRecruiting
CHU MontpellierMontpellier, FranceRecruiting
Hôpital de l'Archet IINice, FranceRecruiting
Assistance Publique - Hôpitaux de ParisParis, FranceRecruiting
CHU BordeauxPessac, FranceRecruiting
Ch Lyon SudPierre-Bénite, FranceRecruiting
CHU RennesRennes, FranceRecruiting
CHU de Saint-EtienneSaint-Etienne, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT06180382