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RECRUITING
NCT06180382
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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