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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.
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
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 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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2024-10-31
Completion Date
2027-01
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
Adalimumab
Administration of adalimumab with optimisation either 80 mg every 14 days by subcutaneous injection, or the same dose of 40 mg every 7 days.
Vedolizumab
Strategy B: administration of vedolizumab 300mg by infusion at baseline, 14 days, 42 days and 60 days, followed by a dose of 108mg every fortnight by subcutaneous injection.
Locations (12)
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, Paris, France
CHU Amiens
Amiens, France
CHRU Lille
Lille, France
Chu Limoges
Limoges, France
APHM
Marseille, France
CHU Montpellier
Montpellier, France
Hôpital de l'Archet II
Nice, France
Assistance Publique - Hôpitaux de Paris
Paris, France
CHU Bordeaux
Pessac, France
Ch Lyon Sud
Pierre-Bénite, France
CHU Rennes
Rennes, France
CHU de Saint-Etienne
Saint-Etienne, France