Study Comparing Vedolizumab and Adalimumab for Crohn’s Disease Patients Who No Longer Respond to Adalimumab

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What is this study about?

This clinical trial is focused on studying the treatment of Crohn’s disease, a chronic inflammatory condition of the digestive tract. The study compares two treatments: Vedolizumab and Adalimumab. Vedolizumab is administered as a solution for infusion, while Adalimumab is given as a solution for injection. The purpose of the study is to evaluate the effectiveness of Vedolizumab compared to an increased dose of Adalimumab in patients who have lost their initial response to Adalimumab or have high levels of certain biomarkers, which are substances in the body that can indicate disease activity.

Participants in the study will be randomly assigned to receive either Vedolizumab or an increased dose of Adalimumab. The study will last for up to 52 weeks, with the main evaluation occurring at 24 weeks. During this time, the study will monitor the participants’ response to the treatment, looking for signs of remission, which means a reduction or disappearance of symptoms. The study will also track any side effects and overall health improvements.

The trial aims to provide insights into which treatment strategy is more effective for patients with Crohn’s disease who have not responded well to standard doses of Adalimumab. By comparing these two approaches, the study hopes to improve treatment options and outcomes for individuals living with this challenging condition.

1 joining the study

Upon joining the study, consent is required to participate. This involves understanding the purpose of the trial and agreeing to the procedures involved.

Eligibility is confirmed based on having Crohn’s disease and a previous response to Adalimumab treatment, with a loss of response or high biomarker activity.

2 initial assessment

An initial assessment is conducted to evaluate current health status and establish baseline measurements. This may include blood tests and other diagnostic procedures.

3 randomization

Participants are randomly assigned to one of two groups: one group will receive Vedolizumab treatment, and the other will have an increased dose of Adalimumab.

4 treatment phase

For those receiving Vedolizumab, the medication is administered as a solution for infusion. The specific dosage and frequency will be determined by the study protocol.

Participants in the Adalimumab group will receive a higher dose than the standard 40 mg every two weeks. The exact dosage will be adjusted according to the study requirements.

5 monitoring and follow-up

Regular monitoring is conducted to assess the effectiveness of the treatment and any side effects. This includes clinical evaluations and biomarker tests.

Follow-up visits are scheduled at specific intervals, such as at 12 weeks, 24 weeks, and 52 weeks, to evaluate progress and make necessary adjustments to the treatment plan.

6 final assessment

At the end of the study period, a final assessment is conducted to determine the overall effectiveness of the treatment. This includes evaluating clinical remission and biomarker levels.

Who Can Join the Study?

The patient must be an adult and must have given consent to participate in the study.
The patient must have Crohn’s disease and have previously responded to a medication called Adalimumab or a similar drug. However, the patient must now have a reduced response to Adalimumab (40 mg every two weeks) and/or show high activity of disease markers in the blood, even though the drug levels are adequate (more than 7.5 micrograms per milliliter).
The patient must be affiliated with or entitled to a social security scheme.
Both male and female patients can participate.
The study is open to patients who are not considered part of a vulnerable population.

Who Cannot Join the Study?

Patients who do not have Crohn’s disease cannot participate.
Patients who are not experiencing a loss of secondary response to their current treatment cannot participate. This means their current treatment is still working well for them.
Patients who do not have high biomarker activity cannot participate. Biomarkers are substances in the body that can indicate how active the disease is.
Patients who are not on a standard-dose Adalimumab maintenance therapy cannot participate. Adalimumab is a medication used to treat Crohn’s disease.
Patients who do not have therapeutic drug levels cannot participate. This means the amount of medication in their body is not at the right level to be effective.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Clinique Pasteur	Toulouse	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Chorale Du Centre Hospitalier De Lens	Lens	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Sante Atlantique	Saint-Herblain	France
Cqlaea Hgqyvhkmtid Vvpwcsg	Valence	France
Cmtcxi Hdkqmtefpuv Ea Uxyhkntzfwlts Dv Lgzgykj	Limoges	France
Adiuyxgfhf Padtrgrr Hpymbgqp Dr Mttyctqxx	Marseille	France
Izbaviga Overdqojjjbyake Dc llkkkbbzaqbat Jwtfz Vhddk	Nantes	France
Iccdkisl di Cbbnuqeonzdi Hfkozalvmra Usqyxpiecplet du Szuwe Efzaigv (ggioheg	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Vedolizumab is a medication used to treat Crohn’s disease, which is a condition that causes inflammation in the digestive tract. This medication works by blocking a specific protein in the body that causes inflammation. By doing this, Vedolizumab helps to reduce the symptoms of Crohn’s disease, such as stomach pain and diarrhea, and can help patients achieve remission, meaning their symptoms are reduced or disappear.

Adalimumab is another medication used to treat Crohn’s disease. It is a type of drug known as a biologic, which means it is made from living cells. Adalimumab works by blocking a protein in the body that causes inflammation, helping to reduce the symptoms of Crohn’s disease. In this trial, the focus is on adjusting the dose of Adalimumab to see if it can help patients who have stopped responding to the standard dose or have high levels of inflammation markers in their blood.

Crohn’s disease – Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active disease, known as flare-ups, and periods of remission. During flare-ups, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications like strictures or fistulas. Over time, the disease can cause damage to the digestive tract, potentially leading to further complications. The progression of Crohn’s disease varies among individuals, with some experiencing frequent flare-ups and others having long periods of remission.

Trial ID:

2023-508154-25-00

Protocol code:

23CH214

NCT ID:

NCT06180382

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Vedolizumab and Adalimumab for Crohn’s Disease Patients Who No Longer Respond to Adalimumab

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?