Crohn'sRecruiting

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.

Phase 4 · Testing Adalimumab and Vedolizumab · 12 sites · Centre Hospitalier Universitaire de Saint Etienne

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Adalimumab (a drug) and Vedolizumab (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.

Who can join

Ages 18 and older
Any sex

Some of the main requirements, copied from the record:

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

There are also 20 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 220 participants are expected to take part.
Start date: 2024-10-31.
Main results expected around 2027-10-31 (estimate from the record).
12 study sites listed (12 marked recruiting) in France.

Main thing being measured

ADA optimized versus Vedolizumab as second line (Week 24)

In the researchers’ words

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…

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Phase 4
Study type	Interventional
Conditions	Crohn's Disease
Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Collaborators	Takeda France
Enrollment	220 (estimated)
Start date	2024-10-31
Primary completion (est.)	2027-10-31
First posted	2023-12-22
Last updated	2026-05-05
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
ClinicalTrials.gov ID	NCT06180382

Interventions

Adalimumab (Drug)
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 (Drug)
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.

Full eligibility criteria (from the record)

Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnant woman
* 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 cancer
* 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
* Patient with ileoanal pouchitis or ileorectal anastomosis
* Patient with short small bowel syndrome as determined by investigator
* Patients receiving total parenteral nutrition (TPN)
* Patients receiving enteral nutrition
* Patient under legal protection or unable to give consent
* Hemorrhagic rectocolitis or indeterminate colitis
* Patients treated with concomitant immunosuppressive agents
* Patient treated with an optimized dose of adalimumab
* Primary non-responder to Adalimumab
* Patient previously treated with infliximab or ustekinumab before adalimumab
* Severe relapse defined by CDAI > 330
* Patient with anoperineal Crohn's disease
* Crohn's disease patient with transient or permanent stoma.

Locations (12)

Site	City	Country	Site status
CHU Amiens	Amiens	France	Recruiting
CHRU Lille	Lille	France	Recruiting
Chu Limoges	Limoges	France	Recruiting
APHM	Marseille	France	Recruiting
CHU Montpellier	Montpellier	France	Recruiting
Hôpital de l'Archet II	Nice	France	Recruiting
Assistance Publique - Hôpitaux de Paris	Paris	France	Recruiting
CHU Bordeaux	Pessac	France	Recruiting
Ch Lyon Sud	Pierre-Bénite	France	Recruiting
CHU Rennes	Rennes	France	Recruiting
CHU de Saint-Etienne	Saint-Etienne	France	Recruiting
APHP - Hôpital Bicêtre	Le Kremlin-Bicêtre, PARIS	France	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.