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Study Comparing Standard Care and Targeted Treatment with Telemonitoring for Ulcerative Colitis Patients Using Adalimumab

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 ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The trial will use a medication called adalimumab, which is also known by the brand name Humira. This medication is given as a solution for injection under the skin. The purpose of the study is to compare the usual care for ulcerative colitis with a new approach that includes setting specific treatment goals, using telemonitoring (remote health monitoring through technology), and providing patient education.

Participants in the study will be randomly assigned to one of two groups. One group will receive the standard treatment for ulcerative colitis, while the other group will follow the new approach. This new approach involves regular monitoring of a substance called fecal calprotectin at home, which helps track inflammation levels, along with educational support to help manage the condition. The study will last for 48 weeks, during which the effectiveness of the treatments will be assessed.

The trial aims to see if the new approach can lead to better outcomes, such as achieving remission, which means the symptoms of ulcerative colitis are reduced or disappear. The study will also look at other factors like quality of life, patient satisfaction, and the number of hospital visits related to ulcerative colitis. Participants will be monitored for safety and how well they tolerate the treatment. The results will help determine if the new approach is more effective than the standard treatment for managing ulcerative colitis.

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
Initiation of treatment
The trial begins with the initiation of treatment using adalimumab, known by the brand name Humira. This medication is administered as a subcutaneous injection, which means it is injected under the skin.
The dosage is 40 mg, provided in a pre-filled syringe. The frequency and duration of administration will be determined by the study protocol and communicated to you by the healthcare team.
Step 2
Monitoring and follow-up
Throughout the trial, regular monitoring will occur. This includes e-Monitoring and at-home testing for fecal calprotectin, a marker used to assess inflammation in the intestines.
You will receive education on how to manage your condition and use the monitoring tools effectively.
Step 3
Evaluation of treatment response
The primary goal is to achieve endoscopic remission by week 48, which means no visible signs of inflammation during an endoscopy.
Secondary goals include achieving clinical remission, which is defined by a total Mayo score of 2 points or less, and other health improvements such as remission without steroids and endoscopic healing.
Step 4
Quality of life assessment
Your quality of life will be evaluated at various points during the trial, specifically at the start and at weeks 14, 26, 38, and 48.
This assessment will help determine the impact of the treatment on your daily life and overall well-being.
Step 5
Completion of trial
The trial is expected to conclude by September 30, 2028. At the end of the trial, the results will be analyzed to determine the effectiveness and safety of the treatment.
Your participation will contribute to understanding the best approaches for managing ulcerative colitis with adalimumab.

Who can join the trial?

11 criteria

Adults with **moderately-to-severely active Ulcerative Colitis** who did not respond well to or could not tolerate certain medications like steroids, thiopurines (azathioprine or 6-mercaptopurine), methotrexate, or vedolizumab.
Women who can have children must use a **contraceptive method** during the entire trial.
Patient must be comfortable using a **smartphone and the internet**.
Age must be **18 years or older and less than 75 years**.
Patients must be scheduled to start treatment with **adalimumab**.
Patients must not have used **anti-TNF therapy** or other similar treatments for Ulcerative Colitis, except for vedolizumab.
Patients must not have used **JAK inhibitors**.
Adults must have had **moderately-to-severely active Ulcerative Colitis** for at least 3 months, with a **Mayo score** between 6 and 12 points. The Mayo score is a way to measure the severity of Ulcerative Colitis.
Patients must have been diagnosed with Ulcerative Colitis for at least 3 months. Different types of Ulcerative Colitis like **pancolitis, left-sided colitis, proctosigmoiditis, and proctitis** are allowed.
Patients must be treated with **oral 5-ASA** at the time of joining the study, unless there is a reason not to use it.
Medications like **azathioprine, 6-mercaptopurine, or methotrexate** must be stopped two weeks before joining the study.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with ulcerative colitis cannot participate. Ulcerative colitis is a condition that causes inflammation and sores in the colon and rectum.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not eligible for treatment with adalimumab (Humira®) cannot participate. Adalimumab is a medication used to reduce inflammation.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Besancon University Hospital Center
Besançon, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Adalimumab: This medication is used in the trial to treat patients with ulcerative colitis. It is a type of drug known as a biologic, which works by blocking a specific protein in the body that causes inflammation. By reducing inflammation, adalimumab helps to control symptoms of ulcerative colitis, such as abdominal pain and diarrhea, and can help achieve and maintain remission of the disease.

Adalimumab

What is already known about the treatment

Adalimumab – This medication is administered via subcutaneous injection and is currently well-established in medical practice and literature. It is primarily used to treat ulcerative colitis, a chronic inflammatory bowel disease. Adalimumab works by blocking a specific protein in the body called tumor necrosis factor (TNF), which plays a role in inflammation. It is classified as a TNF inhibitor, helping to reduce inflammation and alleviate symptoms associated with the condition.

Investigated diseases

Ulcerative colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of flare-ups and remissions. During flare-ups, symptoms can become more severe, while remissions may bring relief. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response. The condition can significantly impact a person's quality of life, requiring ongoing management and monitoring.