RecruitingPhase 4NCT06180382

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.

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


Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

220 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is for people with Crohn's disease — a chronic inflammatory bowel condition — who were doing well on a biologic drug called adalimumab but have started to lose its effectiveness, even though blood tests show they still have enough of the drug in their system. The study compares two strategies: switching to a different biologic (vedolizumab) versus increasing the adalimumab dose. **You may be eligible if...** - You have Crohn's disease and initially responded well to adalimumab - You are now experiencing a return of symptoms despite adequate adalimumab levels in your blood (above 7.5 mcg/mL) - You are 18 or older and have provided informed consent - You have active disease signs confirmed by biomarkers (e.g., elevated CRP or fecal calprotectin) **You may NOT be eligible if...** - You never responded to adalimumab in the first place - Your adalimumab blood levels are too low (subtherapeutic) - You have already tried vedolizumab - You have serious infections or other conditions that prevent biologic therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdalimumab

Administration of adalimumab with optimisation either 80 mg every 14 days by subcutaneous injection, or the same dose of 40 mg every 7 days.

DRUGVedolizumab

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

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NCT06180382


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