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.

NCT06180382 | Recruiting Phase 4

• 2 other identifiers: 23CH1342023-508154-25-00
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Crohn's Disease

Keywords

Crohn's disease; Adalimumab; Vedolizumab; therapeutic strategy; Efficacy; biomarker

Outcome Measures

Primary Outcomes (1)

• ADA optimized versus Vedolizumab as second line

  The primary objective will be to compare the proportion of clinical and biomarker remission (composite score) in the two groups of CD patients by 24 weeks after inclusion.

  Week 24

Secondary Outcomes (17)

• Proportion of deep remission

  Weeks 0; 24

• Proportion of clinical remission

  Weeks 0; 24

• faecal calprotectin (microG / g)

  Week 24

• serum C-reactive protein (CRP) mg/l

  Week 24

• Proportion of endoscopic remissions according to Crohn's Disease Endoscopic Index score (CDEIS)

  Week 24

Study Arms (2)

Adalimumab with optimisation

EXPERIMENTAL

Patients with Crohn's disease will be included. They will have Adalimumab with optimisation as treatment.

Drug: Adalimumab

Vedolizumab

EXPERIMENTAL

Patients with Crohn's disease will be included. They will have Vedolizumab as treatment.

Drug: Vedolizumab

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.

Adalimumab with optimisation

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.

Vedolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• Pregnant woman
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Takeda France: collaborator

Study Sites (12)

APHP - Hôpital Bicêtre

Le Kremlin-Bicêtre, PARIS, 94270, France

RECRUITING

CHU Amiens

Amiens, 80000, France

RECRUITING

CHRU Lille

Lille, 59037, France

RECRUITING

Chu Limoges

Limoges, 87000, France

RECRUITING

APHM

Marseille, 13000, France

RECRUITING

CHU Montpellier

Montpellier, 34295, France

RECRUITING

Hôpital de l'Archet II

Nice, 06202, France

RECRUITING

Assistance Publique - Hôpitaux de Paris

Paris, 75004, France

RECRUITING

CHU Bordeaux

Pessac, 33604, France

RECRUITING

Ch Lyon Sud

Pierre-Bénite, 69230, France

RECRUITING

CHU Rennes

Rennes, 35033, France

RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab; vedolizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mathilde BARRAU, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathilde BARRAU, MD

CONTACT

(0)477829626; mathilde.barrau@chu-st-etienne.fr

Sandra COURNIER, project manager

CONTACT

(0)477127652; sandra.cournier@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization comparing 2 therapeutic strategies

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: October 31, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)