Actively 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.
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-05-05
220
Participants Needed
12
Research Sites
208 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Saint Etienne
Lead Sponsor
T
Takeda France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, PARIS, France, 94270
Actively Recruiting
2
CHU Amiens
Amiens, France, 80000
Actively Recruiting
3
CHRU Lille
Lille, France, 59037
Actively Recruiting
4
Chu Limoges
Limoges, France, 87000
Actively Recruiting
5
APHM
Marseille, France, 13000
Actively Recruiting
6
CHU Montpellier
Montpellier, France, 34295
Actively Recruiting
7
Hôpital de l'Archet II
Nice, France, 06202
Actively Recruiting
8
Assistance Publique - Hôpitaux de Paris
Paris, France, 75004
Actively Recruiting
9
CHU Bordeaux
Pessac, France, 33604
Actively Recruiting
10
Ch Lyon Sud
Pierre-Bénite, France, 69230
Actively Recruiting
11
CHU Rennes
Rennes, France, 35033
Actively Recruiting
12
CHU de Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
Research Team
M
Mathilde BARRAU, MD
CONTACT
S
Sandra COURNIER, project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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