VEDOLIZUMAB for Crohn's disease

Inclusion criteria

• {"criterion_text":"- Major patient and having given consent to participate in the study\n- Patients with Crohn's disease who responded primarily to the originator or biosimilar adalimumab and have lost response to adalimumab (40 mg every two weeks)\n- Patient affiliated to or entitled under a social security scheme\n- If the subject is receiving oral corticosteroids other than budesonide or beclometasone dipropionate, the dose must be ≤ 20 mg/day of prednisone or its equivalent and have been stable for at least 2 weeks. The use of corticosteroids is prohibited after week 12."}

Exclusion criteria

• {"criterion_text":"- Pregnant woman\n- Patient with short small bowel syndrome as determined by investigator\n- Patients receiving enteral nutrition\n- Patients receiving total parenteral nutrition (TPN).\n- Participation in a therapeutic study\n- Patient under legal protection or unable to give consent\n- Hemorrhagic rectocolitis or indeterminate colitis\n- Patient treated with a concomitant immunosuppressive agent at the time of inclusion. The patient may have been treated with an immunosuppressive agent, but this must have been discontinued at least 4 weeks prior to the screening visit.\n- Patient treated with an optimized dose of adalimumab\n- Primary non-responder to Adalimumab\n- Patient previously treated with ustekinumab before adalimumab\n- Patients with exclusive anoperineal Crohn's disease\n- Severe relapse defined by CDAI > 330\n- Crohn's disease patient with transient or permanent stoma\n- Patients on intravenous corticosteroid therapy\n- Previous or current use of vedolizumab or ustekinumab for Crohn's disease\n- Concomitant use of immunomodulators\n- History of cancer\n- 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.\n- Patient with ileoanal pouchitis or ileorectal anastomosis"}

Primary endpoints

• {"endpoint_text":"- 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 (ADA optimized versus Vedolizumab as second line).","definition_or_measurement_approach":"Proportion of patients achieving clinical and biomarker remission (composite score) at 24 weeks after inclusion comparing ADA optimized versus Vedolizumab strategy."}

Secondary endpoints

• {"endpoint_text":"- Compare deep remission defined as clinical remission (clinical activity score < 150 with fecal calprotectin < 250 mcg/g stools and CRP < 5mg/L and either CDEIS <3 using ileocolonoscopy or Lewis score < 135 in the small bowel using VCE or no disease activity on MRE (defined by segmental Maria score < 7) or no bowel thickness on US according to the previous tools used at inclusion at W24.\n- Compare treatment failure at W24 or W52 in the 2 groups\n- Compare the percentage of adverse events in both arms at W52\n- Symptomatic remission at W24 is a composite criterion measured by PRO2 defined as: Stool frequency (SF) < 3 with abdominal pain score (AP) < 2 at W24; AND absence of therapeutic failure between inclusion and W24.\n- Compare evolution of IBDQ-32 in the two groups of patients between inclusion and W24\n- Compare rates of clinical and biomarker remission at W12\n- Compare rates of clinical and biomarker remission at W52\n- Mucosal remission at week 24 will be defined by: • A CDEIS score < 3 at week 24 using ileocolonoscopy; • OR a Lewis score < 135 at week 24 in the small intestine using VCE (video capsule endoscopy); • OR no ulceration using VCE at week 24; • OR no activity on MRI at week 24 (defined by a segmental Maria score < 7); • OR no intestinal thickening on ultrasound at week 24 (< 3 mm with no other signs of activity).\n- Analyze the CDST (clinical decision support tool) score for prediction of remission under vedolizumab and adalimumab optimization.\n- Pharmacodynamic failure: Therapeutic blood ADA level (> 7.5 µg/mL) Pharmacokinetic failure: Subtherapeutic blood ADA level (< 7.5 µg/mL) Immunogenic failure (undetectable blood ADA level with presence of anti-ADA antibodies >50 ng/mL).","definition_or_measurement_approach":"Definitions provided per endpoint in protocol: deep remission defined by clinical score, fecal calprotectin, CRP and endoscopic/imaging criteria at W24; symptomatic remission via PRO2 (SF <3 and AP <2) and absence of therapeutic failure; mucosal remission defined by CDEIS, Lewis score, VCE ulceration absence, MRI (segmental Maria <7) or ultrasound criteria; ADA level–based classification: pharmacodynamic (>7.5 µg/mL), pharmacokinetic (<7.5 µg/mL), immunogenic (undetectable ADA with anti-ADA >50 ng/mL). Other endpoints measured at specified weeks (W12, W24, W52) and via IBDQ-32 for quality of life."}

France

Earliest CTIS Part Ii Submission Date

11-12-2023

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

856

Number Of Sites

18

Number Of Participants

220

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Saint Etienne

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"TAKEDA FRANCE S.A.S","duties_or_roles":"Monetary support","organisation_type":""}