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Study on Vedolizumab and Ustekinumab for Patients with Crohn's Disease and Ulcerative Colitis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two types of Inflammatory Bowel Disease (IBD), which are Crohn's disease and Ulcerative colitis. These are conditions that cause inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The study will use two medications, Vedolizumab and Ustekinumab, to see how well they work in keeping these diseases under control. Vedolizumab, also known by its code names MLN0002 and PB016, is given through an intravenous infusion, which means it is administered directly into a vein. Ustekinumab, with code names like Bmab 1200 and CNTO 1275, is given as a subcutaneous injection, meaning it is injected under the skin.

The purpose of the study is to find out if adjusting the doses of these medications based on regular monitoring of drug levels in the blood is as effective as the usual practice where the doctor decides the best dose. This approach is called Therapeutic Drug Monitoring (TDM). Participants in the study will receive either Vedolizumab or Ustekinumab, and their health will be monitored over a period of 48 weeks to see if the disease stays in remission, which means the symptoms are reduced or disappear.

Throughout the study, the researchers will also look at other factors, such as the cost of the treatments, the quality of life of the participants, and any changes in their health condition. The study aims to provide valuable information on the best way to use these medications to help people with Crohn's disease and Ulcerative colitis manage their symptoms effectively.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of either ulcerative colitis or Crohn's disease and ensuring stable treatment with either vedolizumab or ustekinumab for at least three months prior to inclusion.
Step 2
Treatment allocation
Participants will be randomly assigned to one of two groups. One group will receive treatment based on therapeutic drug monitoring (TDM), while the other group will receive treatment as determined by the treating physician.
Step 3
Medication administration
Participants will continue their current medication regimen. Vedolizumab is administered through an intravenous infusion, and ustekinumab is administered via a subcutaneous injection. The frequency and dosage will be determined based on the assigned treatment group.
Step 4
Regular monitoring
Throughout the 48-week observation period, regular monitoring will occur. This includes assessments of disease activity, quality of life, and any side effects. Blood tests and other evaluations may be conducted to measure inflammation and drug levels.
Step 5
End of study assessment
At the end of the 48-week period, a final assessment will be conducted. This will evaluate the effectiveness of the treatment in maintaining remission without the use of steroids, as well as any changes in quality of life and disease activity.

Who can join the trial?

7 criteria

The patient must have been diagnosed with either Ulcerative Colitis or Crohn's Disease at least 3 months before joining the study.
The patient must be at least 18 years old.
The patient must have been on a stable treatment with either Vedolizumab (VDZ) or Ustekinumab (UST) for at least 3 months before joining the study.
The patient's disease activity must be stable, with no changes in medical treatment within the last 3 months. Mild disease activity is allowed, which means certain test results should be within specific limits.
No changes in medical treatment within the last 3 months are allowed, but the patient can be on other immune-suppressing medications like Azathioprine, 6-mercaptopurine, Methotrexate, or 5-aminosaliclyic acid.
The patient must be able to understand the information provided about the study.
The patient must be able to give informed written consent to participate in the study.

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to the study medications cannot participate.
Patients who are currently pregnant or breastfeeding are not eligible.
Individuals with a history of certain types of cancer may be excluded.
Patients with active infections that require treatment with antibiotics, antivirals, or antifungals are not allowed to join the study.
People who have received another investigational drug within the last 30 days cannot participate.
Patients with a history of drug or alcohol abuse within the past year are not eligible.
Individuals with certain heart conditions may be excluded from the study.
Patients who have had a major surgery within the last 3 months are not allowed to participate.
People with a history of certain autoimmune diseases may be excluded.
Patients who are unable to comply with the study procedures and visits are not eligible.

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Verified sites

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Verified
Aalborg University Hospital
Aalborg, Denmark
Verified
Hvidovre Hospital
Hvidovre, Denmark
Verified
Odense University Hospital
Odense, Denmark

Trial locations

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Investigated drugs

Ustekinumab
is a medication used to help manage inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis. It works by targeting specific proteins in the immune system that cause inflammation. By reducing this inflammation, Ustekinumab can help keep the symptoms of these diseases under control and maintain remission, which means the disease is not active.
Vedolizumab
is another medication used to treat inflammatory bowel diseases. It works by blocking certain cells in the immune system from reaching the gut, where they can cause inflammation. This helps to reduce the symptoms of the disease and keep it in remission, allowing patients to have a better quality of life without the active symptoms of the disease.

What is already known about the treatment

Ustekinumab
Ustekinumab is administered through an injection, typically under the skin, and is used to treat inflammatory bowel diseases like Crohn's disease and ulcerative colitis. It is well-documented in medical literature as an effective treatment for these conditions. Ustekinumab works by targeting specific proteins in the immune system that cause inflammation, helping to reduce symptoms and maintain remission. It is classified as a monoclonal antibody, which is a type of medication designed to target specific molecules in the body.
Vedolizumab
Vedolizumab is given as an infusion into a vein and is used to manage inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. It is recognized in medical literature for its role in maintaining remission in these conditions. Vedolizumab works by blocking a protein that allows certain immune cells to enter the gut, thereby reducing inflammation and symptoms. It belongs to a class of drugs known as integrin receptor antagonists, which help control the immune response in the gut.

Investigated diseases

Crohn's Disease
Crohn's Disease is a chronic inflammatory condition that affects the gastrointestinal tract, most commonly the end of the small intestine and the beginning of the colon. It causes inflammation that can penetrate deep into the layers of the bowel tissue. The disease often leads to symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. Over time, the inflammation can cause complications like strictures, fistulas, and malnutrition. The progression of Crohn's Disease is unpredictable, with periods of flare-ups and remission. The inflammation can also affect other parts of the body, leading to joint pain and skin problems.
Ulcerative Colitis
Ulcerative Colitis is a chronic inflammatory condition that specifically affects the colon and rectum. It causes continuous inflammation and ulceration of the innermost lining of the colon. Symptoms typically include abdominal pain, diarrhea with blood or pus, and an urgent need to defecate. The disease progresses with alternating periods of active symptoms and remission. Over time, the inflammation can lead to complications such as severe bleeding, perforated colon, and increased risk of colon cancer. The inflammation is usually limited to the colon, but it can also cause symptoms in other parts of the body, such as joint pain and skin rashes.