A study comparing vedolizumab, filgotinib, ustekinumab, and infliximab to maintain remission in patients with ulcerative colitis

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What is this study about?

This study focuses on Ulcerative Colitis, a disease that causes inflammation and sores in the lining of the large intestine. The purpose of the study is to compare different types of advanced medicines used to keep the disease in a state of remission, which means a period where symptoms are minimal or absent. The medications being studied include ustekinumab, infliximab, filgotinib, and vedolizumab.

The treatments involve different methods of delivery. Some medicines, such as infliximab, ustekinumab, and vedolizumab, are given through intravenous infusion, which is a process where medicine is delivered directly into a vein. Another medicine, filgotinib, is taken as an oral tablet. These medications belong to different classes, including anti-TNF agents, anti-IL12/23, JAK inhibitors, and anti-integrins, which are specific ways that drugs work to target the parts of the immune system causing inflammation.

During the study, participants will receive one of these treatments to see how well it helps maintain health and manage the disease over time. The process involves regular monitoring to check for the disappearance of symptoms like rectal bleeding and changes in bowel habits. The study will observe how these different medicines perform in helping patients achieve long-term stability without the need for steroids, which are a type of medicine often used to reduce swelling and inflammation.

Who Can Join the Study?

  • Both men and women can participate, but women who may become pregnant must use effective contraception (birth control) and have a negative pregnancy test.
  • You must be between 18 and 65 years old.
  • You must have been diagnosed with ulcerative colitis (a type of long-term inflammation in the large intestine) for at least 3 months.
  • Your disease must be classified as moderate to severe based on the modified Mayo score (a tool doctors use to measure the severity of your symptoms and disease activity).
  • Your endoscopic Mayo score must be 2 or higher (an endoscopic score is a measurement taken by a doctor using a camera to look inside your intestine to see the level of inflammation).
  • You must have not responded well to, failed to improve with, lost the benefits of, or not been able to tolerate 5-ASA (a type of anti-inflammatory medicine), steroids (medicines that reduce swelling and inflammation), or immunosuppressants (medicines that lower the activity of your immune system).
  • You must be able to give consent (formally agree to participate in the study).
  • You must be covered by the French healthcare system.

Who Cannot Join the Study?

  • You have a reason why you cannot take infliximab, filgotinib, vedolizumab, or ustekinumab, which are specific types of advanced medications used for treatment.
  • You have previously used other biologics (medicines made from living organisms) or experimental drugs (medicines that are still being tested).
  • You do not have health insurance.
  • You are pregnant or currently breastfeeding (lactating).
  • You are already participating in another medical research study, unless it is an observational study (a study where doctors simply watch and record what happens without changing your treatment).
  • You have a current infection with Clostridioides difficile, which is a type of bacteria that causes severe diarrhea and gut inflammation.
  • You have an HIV infection, which is a virus that attacks the body’s immune system.
  • You do not speak or understand the French language.
  • You are under guardianship, curatorship, or safeguard of justice, which means a legal representative makes decisions for you.
  • You are a minor (under the age of 18).
  • You have taken more than 20 mg per day of steroids (strong anti-inflammatory medicines) within the last two weeks.
  • You have low proctitis, which means your inflammation is only located in the rectum (the very end of the large intestine) and covers a distance of less than 5 cm.
  • You have a history of thromboembolism, which refers to blood clots that form in blood vessels.
  • You have a history of major cardiovascular problems, such as a heart attack or a stroke (when blood flow to the brain is blocked).
  • You are a long-term smoker with a history of more than 40 pack years (a measurement based on how many cigarettes you smoke per day multiplied by the number of years you have smoked).
  • You have Crohn’s disease, which is a different type of chronic inflammatory bowel disease.
  • You have a stoma (an opening surgically created on the abdomen to allow waste to leave the body) or have had a colectomy (surgical removal of part or all of the colon).
  • You have previously used anti-TNF agents, anti-integrins, anti-interleukines 12 and 23, or JAK inhibitors.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Colmar Colmar France
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire De Nimes Nimes France
Hopital Beaujon Clichy France
Centre Hospitalier D Avignon Avignon France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
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Iiorkstb Mgpftjsssn Mfeohlkntt Paris France
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Azmtoddsbc Pjutzrpz Hasahccx Dn Maliemlwt Marseille France
Bhvkaxcy Uawfbfxkof Hcnbhrhh Chchwo Besançon France
Czqxcm Htbkvaeuuit Rzkgzaos Ueotenynxvuae Df Tyhrz Tours France
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Ijcneqhd dp Cjdvufshntvh Hlcmyksbqnj Uwesqtyebyjnr dw Stcns Eqoorxf (xraawqq Saint Priest En Jarez France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.06.2026

Trial locations

Ustekinumab is a medication given through an intravenous infusion that works by targeting specific proteins in the immune system to help reduce inflammation in patients with ulcerative colitis.

Infliximab is a medication administered by intravenous infusion that helps control inflammation by targeting a specific protein in the body that contributes to the disease.

Filgotinib is a medication taken as a pill that helps manage inflammation by blocking certain pathways in the immune system.

Vedolizumab is a medication given through an intravenous infusion that works by targeting specific cells in the immune system to limit inflammation in the digestive tract.

Investigated diseases:

ulcerative colitis – This is a condition involving long-term inflammation of the inner lining of the large intestine and rectum. The inflammation typically occurs in a continuous pattern rather than in patches. As the disease progresses, it can cause irritation and swelling of the intestinal tissues. This may lead to symptoms such as frequent bowel movements and blood in the stool. The extent of the inflammation can vary from affecting only the rectum to involving the entire colon.

Trial ID:
2024-514964-24-00
Protocol code:
PHRC N 2020 BUISSON
Trial Phase:
Therapeutic confirmatory (Phase III)

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