Study on Vedolizumab for Patients with Active Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying ulcerative colitis, a condition that causes inflammation and sores in the lining of the large intestine. The trial will explore the effectiveness of a treatment using a medication called vedolizumab. Vedolizumab is available in two forms: a 300 mg powder that is mixed into a solution and given through an intravenous infusion, and a 108 mg solution that is injected using a pre-filled syringe.

The purpose of the study is to determine the best treatment target for people with moderately to severely active ulcerative colitis. Participants will be divided into groups to receive different treatment targets. The study will compare whether aiming for a more comprehensive remission, which includes being free from symptoms, endoscopic signs, and histological signs without the use of corticosteroids, is better than just aiming for symptom relief without corticosteroids. The study will follow participants for up to 80 weeks after they achieve their treatment target to see if there are any complications related to ulcerative colitis.

Throughout the study, participants will receive regular assessments to monitor their progress and any changes in their condition. The trial will also look at various health indicators, such as levels of certain proteins in the blood and stool, to understand the effects of the treatment. The goal is to find the most effective way to manage ulcerative colitis and improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, the participant will be required to provide written informed consent. This confirms understanding and agreement to participate in the trial.

Eligibility will be confirmed based on criteria such as age, diagnosis of ulcerative colitis, and other health assessments.

2 initial assessment

An initial assessment will be conducted to evaluate the current state of ulcerative colitis. This includes clinical, endoscopic, and histological evaluations.

Tests for tuberculosis and hepatitis B and C will be performed if recent results are not available.

3 treatment administration

Participants will receive vedolizumab, a medication used to treat ulcerative colitis.

The medication will be administered in two forms: intravenous infusion of Entyvio 300 mg and subcutaneous injection of Entyvio 108 mg.

The frequency and duration of administration will be determined by the study protocol and the participant’s response to treatment.

4 monitoring and follow-up

Participants will be monitored regularly to assess the effectiveness of the treatment and any side effects.

Assessments will include changes in symptoms, endoscopic findings, and histological evaluations at specified intervals up to 96 weeks.

Regular blood tests and other evaluations will be conducted to monitor health and response to treatment.

5 evaluation of treatment targets

The trial aims to achieve specific treatment targets, such as corticosteroid-free symptomatic remission and endoscopic remission.

Participants will be evaluated to determine if these targets are met, and adjustments to treatment may be made based on these evaluations.

6 completion of the trial

The trial is expected to continue until April 2026, with participants followed for up to 80 weeks after achieving treatment targets.

Upon completion, participants will undergo a final assessment to evaluate the overall effectiveness and safety of the treatment.

Who Can Join the Study?

You must be 18 years or older.
You need to be up to date with colorectal cancer checks according to local guidelines. If not, you can have this check during the screening period.
You must have a diagnosis of ulcerative colitis (UC) confirmed by medical tests before the screening.
Your UC should be moderately to severely active, with specific scores on medical tests and a minimum affected area of 15 cm that can be seen using a special camera system.
You should be able to participate fully in all parts of the clinical trial.
You need to provide written informed consent, which means you agree to participate after understanding the trial details.
You must agree not to join another investigation trial during this study. However, some non-interventional trials might be allowed.
You need to have a negative test for tuberculosis (TB) and hepatitis B and C before starting the trial, unless you have negative results from the past 12 months.
If you are a non-sterilized male and sexually active with a female partner who can have children, you must agree to use adequate contraception from the time you sign the consent until 18 weeks after the last dose.
If you are a female who can have children and sexually active with a non-sterilized male partner, you must agree to use adequate contraception from the time you sign the consent until 18 weeks after the last dose.

Who Cannot Join the Study?

Patients who have other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery related to their ulcerative colitis.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have a history of not responding to similar treatments in the past.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study medication.
Patients who have a history of drug or alcohol abuse.
Patients who have an active infection that requires treatment.
Patients who have been diagnosed with cancer in the past five years.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Niepubliczny Zaklad Opieki Zdrowotnej Salmed	Leczna	Poland

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Sonomed Sp. z o.o.	Szczecin	Poland
Szpital Miejski Sw. Jana Pawla II W Elblagu	Elblag	Poland
Endoskopia Sp. z o.o.	Sopot	Poland
Azienda Ospedaliera di Padova	Padua	Italy
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Gastromed Sp. z o.o.	Torun	Poland
Irebgh	Bonheiden	Belgium
Gptfbvv Eizwruwzfs Pyccetlf Pjoxabxoefq	Cracow	Poland
Ajezxlwiy Uzu	Amsterdam	The Netherlands
Bqscxdco Ugrraucnpu Hygzsgko Cqsjdi	Besançon	France
Soz Elvtmmigz Hhvlreif Tbrxrpf	Tilburg	The Netherlands
Adubhsv Uywrn Sxmcsllhe Lmmouj Db Bcoxmjg	Bologna	Italy
Ilfpqreg de Cgoetopwvwvs Hofwjizasao Urheaikvcoyrd dr Szkrc Efzwofj (coscciv	Saint Priest En Jarez	France
Wus Wircds Idi Pdrga Pfrpurah Kyctzyp	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.02.2021
France	Not recruiting	01.02.2021
Italy	Not recruiting	01.02.2021
Poland	Not recruiting	01.02.2021
The Netherlands	Not recruiting	01.02.2021

Trial locations

Investigated drugs:

Vedolizumab

Corticosteroids are medications used to reduce inflammation in the body. In this trial, they are used to help manage symptoms of ulcerative colitis by reducing inflammation in the colon. The goal is to achieve remission without the need for ongoing corticosteroid use.

Symptomatic Treatment involves using medications or therapies to relieve the symptoms of ulcerative colitis, such as abdominal pain and diarrhea, without necessarily addressing the underlying inflammation.

Endoscopic Treatment refers to therapies aimed at improving the appearance of the colon lining as seen through an endoscope. This is used to assess and treat the inflammation and damage caused by ulcerative colitis.

Histological Treatment involves targeting the microscopic inflammation in the colon tissue. This approach aims to achieve remission by ensuring that the tissue appears normal under a microscope, indicating that the inflammation has been effectively treated.

Ulcerative colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission, where symptoms may worsen and then improve. Over time, the inflammation can cause ulcers to form on the colon lining, which may lead to complications if not managed. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response in genetically predisposed individuals. Environmental factors and gut microbiota may also play a role in its development and progression.

Trial ID:

2024-514183-21-00

Protocol code:

RP1706

NCT ID:

NCT04259138

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Vedolizumab for Patients with Active Ulcerative Colitis

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