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Study on Ulcerative Colitis: Evaluating Early Treatment with Adalimumab for Patients with Severe Symptoms

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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, specifically affecting the innermost lining of the large intestine and rectum. The treatment being tested in this study is called AMGEVITA, which contains the active substance Adalimumab. This medication is administered as a solution for injection using a pre-filled pen.

The purpose of the study is to evaluate a new treatment approach for patients with Ulcerative Colitis who are identified as having a potentially severe outcome within one year. This approach, known as a "top-down" strategy, involves starting treatment with biologic therapy early on, rather than following the usual step-by-step method. The study aims to determine if this early intervention can lead to a higher chance of achieving deep remission, which means the disease is not active, one year after the initial diagnosis.

Participants in the study will receive the treatment and be monitored over time to assess their response. The study will look at various outcomes, including the percentage of patients who achieve deep remission after one year and those who start with biological medication or require surgery within the first year. Additionally, the study will evaluate patient-reported outcomes related to quality of life and medical expenses. The trial is expected to continue until the end of 2031, with recruitment starting in 2025.

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
Joining the study
Upon joining the study, you will be required to sign an informed consent form. This form confirms your understanding of the study and your agreement to participate. It also outlines the requirements and restrictions you must comply with during the trial.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your diagnosis of ulcerative colitis. This involves a colonoscopy and biopsy, which are procedures to examine the inside of your colon and take a small tissue sample for testing.
Step 3
Medication administration
You will receive a medication called AMGEVITA, which contains the active substance adalimumab. This medication is administered as a subcutaneous injection, meaning it is injected under the skin.
The dosage is 40 mg, and the frequency and duration of administration will be determined by the study protocol. It is important to follow the instructions provided by the study team regarding the timing and method of these injections.
Step 4
Ongoing monitoring
Throughout the study, your health and response to the medication will be closely monitored. This may involve regular check-ups, blood tests, and questionnaires to assess your quality of life and symptoms.
You will be asked to report any side effects or changes in your condition to the study team promptly.
Step 5
Completion of study
The study aims to evaluate the effectiveness of the treatment strategy over a period of one year. At the end of this period, your condition will be assessed to determine if you have achieved deep remission, which is a significant reduction or disappearance of symptoms.
You may also be asked to participate in follow-up assessments to evaluate long-term outcomes and any changes in your condition over time.

Who can join the trial?

4 criteria

Participant must be between 18 and 65 years old at the time of signing the consent form.
Participants must be newly diagnosed with ulcerative colitis, confirmed by a colonoscopy and biopsy. A colonoscopy is a test that allows doctors to look inside the colon, and a biopsy is when a small piece of tissue is taken to be examined.
Participants must be able to give signed informed consent. This means they understand the study and agree to follow the rules and restrictions outlined in the consent form.
Women who can have children must use highly effective birth control during the study and for 5 months after the last dose of adalimumab. Adalimumab is a medication used to treat certain conditions, including ulcerative colitis.

Who cannot join the trial?

4 criteria

Patients who do not have a confirmed diagnosis of ulcerative colitis cannot participate. Ulcerative colitis is a condition that causes inflammation and sores in the lining of the large intestine.
Patients who do not have a positive bio-signature are excluded. A bio-signature is a specific pattern of biological markers in the body. For this study, it means having a certain level of a substance called mucosal TNF transcript and a score called RHI.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population are not eligible. This means people who might need special protection or care.

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Universitetssykehuset Nord-Norge HF
Tromsø, Norway

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Investigated drugs

Biologic Therapy is a type of treatment that uses substances made from living organisms to treat diseases. In the context of this trial, biologic therapy is used to treat ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The goal of using biologic therapy early in the treatment process is to help patients achieve deep remission, meaning that the symptoms of the disease are significantly reduced or disappear altogether. This approach is being tested to see if it is more effective for severe cases of ulcerative colitis compared to the traditional method of gradually increasing treatment intensity.

Adalimumab

What is already known about the treatment

Biologic Therapy – This medication is administered through an injection or infusion, directly into the bloodstream, to treat ulcerative colitis. It is currently being studied in clinical trials to determine its effectiveness in achieving deep remission in severe cases of ulcerative colitis. The main therapeutic use is for patients with a severe form of this condition, identified by specific biological markers. At the molecular level, biologic therapy works by targeting and blocking specific proteins, such as TNF (tumor necrosis factor), that cause inflammation in the gut. It is classified as a biologic drug, which is a type of medication made from living organisms.

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 typically begins in the rectum and may extend continuously to involve the entire colon. The inflammation causes the colon to empty frequently, resulting in diarrhea. Over time, the disease can lead to complications such as strictures or a dilated colon. The progression of ulcerative colitis varies, with periods of exacerbation and remission.