Phase
Condition
Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Treatment
Adalimumab
Strategy B
Vedolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 orsimilar bio with loss of response to Adalimumab (40 mg every two weeks) withtherapeutically adequate levels of ADA (> 7.5 μg/mL).
Patient affiliated to or entitled under a social security scheme
Exclusion
Exclusion Criteria:
Pregnant woman
Patient unable to perform MRI or VCE or ileocolonoscopy or ultrasound less than onemonth before inclusion
Previous or current use of vedolizumab or ustekinumab for Crohn's disease orparticipation in a biological study
Concomitant use of immunomodulators
Patients on corticosteroid therapy
History of cancer
History of human immunodeficiency virus (HIV), immunodeficiency syndrome, centralnervous system (CNS) demyelinating disease (including myelitis), neurologicalsymptoms suggestive of demyelinating disease, chronic recurrent infection, activetuberculosis (received or untreated), severe infections such as sepsis andopportunistic 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.
Study Design
Study Description
Connect with a study center
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, Paris 94270
FranceActive - Recruiting
CHU Amiens
Amiens, 80000
FranceActive - Recruiting
CHRU Lille
Lille, 59037
FranceActive - Recruiting
Chu Limoges
Limoges, 87000
FranceActive - Recruiting
APHM
Marseille, 13000
FranceActive - Recruiting
CHU Montpellier
Montpellier, 34295
FranceActive - Recruiting
Hôpital de l'Archet II
Nice, 06202
FranceActive - Recruiting
Assistance Publique - Hôpitaux de Paris
Paris, 75004
FranceActive - Recruiting
CHU Bordeaux
Pessac, 33604
FranceActive - Recruiting
Ch Lyon Sud
Pierre-Bénite, 69230
FranceActive - Recruiting
CHU Rennes
Rennes, 35033
FranceActive - Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
FranceActive - Recruiting
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