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 VEDIAN trial.
EU CTIS ID: 2023-508154-25-00
What this study is testing
Evaluate the efficacy, in terms of clinical remission and biomarkers at week 24, of a therapeutic strategy using vedolizumab compared to a therapeutic strategy using optimized doses of adalimumab (ADA) in patients with CD experiencing secondary loss of response and/or presenting high biomarker activity and/or signs of activity on imaging (MRI or intestinal ultrasound or ileocolonoscopy or video capsule) under a standard maintenance dose of adalimumab treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Major patient and having given consent to participate in the study
- 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)
- Patient affiliated to or entitled under a social security scheme
- 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.
You likely can't join if
- Pregnant woman
- Patient with short small bowel syndrome as determined by investigator
- Patients receiving enteral nutrition
- Patients receiving total parenteral nutrition (TPN).
- Participation in a therapeutic study
- Patient under legal protection or unable to give consent
See the full eligibility criteria
- Major patient and having given consent to participate in the study
- 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)
- Patient affiliated to or entitled under a social security scheme
- 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.
- Pregnant woman
- Patient with short small bowel syndrome as determined by investigator
- Patients receiving enteral nutrition
- Patients receiving total parenteral nutrition (TPN).
- Participation in a therapeutic study
- Patient under legal protection or unable to give consent
- Hemorrhagic rectocolitis or indeterminate colitis
- 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.
- Patient treated with an optimized dose of adalimumab
- Primary non-responder to Adalimumab
- Patient previously treated with ustekinumab before adalimumab
- Patients with exclusive anoperineal Crohn's disease
- Severe relapse defined by CDAI > 330
- Crohn's disease patient with transient or permanent stoma
- Patients on intravenous corticosteroid therapy
- Previous or current use of vedolizumab or ustekinumab for Crohn's disease
- Concomitant use of immunomodulators
- 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
The study team makes the final eligibility decision.
Where it's taking place
- France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.