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Study on the Safety and Effectiveness of Adalimumab as Initial Treatment for Newly Diagnosed Crohn's Disease Patients

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 Crohn's disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The treatment being tested in this study is called adalimumab, which is a medication given as a solution for injection. It is known by the brand name Hyrimoz and is administered through a subcutaneous injection, meaning it is injected under the skin.

The purpose of the study is to compare the long-term effectiveness and safety of using periodic adalimumab as the first treatment for patients newly diagnosed with Crohn's disease, against the standard approach of starting with medications like corticosteroids or budesonide. Participants in the study will receive either the new treatment or the standard treatment, and their progress will be monitored over time to see which approach works better in managing the disease.

The study will follow participants for a period of time to observe how well they respond to the treatment and to check for any side effects. The main goal is to see if patients can achieve remission, which means their symptoms are reduced or disappear, without needing corticosteroids. Other aspects being looked at include the overall health care costs, the total amount of corticosteroids used, and the impact on patients' quality of life. The study aims to provide valuable information that could help improve treatment strategies for people with Crohn's disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The study involves the use of adalimumab, a medication administered through a subcutaneous injection. The specific product used is called Hyrimoz 40 mg solution for injection in pre-filled syringe.
The treatment is designed for individuals newly diagnosed with Crohn's disease or those experiencing a flare-up. The goal is to assess the effectiveness and safety of periodic adalimumab as an initial treatment compared to standard care with corticosteroids or budesonide.
Step 2
Treatment administration
Participants will receive adalimumab injections periodically. The frequency and duration of these injections will be determined by the study protocol and the healthcare team overseeing the trial.
The primary focus is to achieve and maintain remission of Crohn's disease symptoms without the use of corticosteroids over a period of 96 weeks.
Step 3
Monitoring and assessments
Throughout the trial, participants will undergo regular monitoring to evaluate the effectiveness of the treatment. This includes clinical assessments and biochemical tests to check for remission of symptoms.
Safety assessments will also be conducted to monitor for any adverse effects related to the medication or disease progression.
Step 4
End of study evaluations
At the end of the 96-week period, a comprehensive evaluation will be conducted to determine the overall success of the treatment in maintaining remission without corticosteroids.
Secondary outcomes such as healthcare costs, cumulative corticosteroid dose, and quality of life measures will also be assessed.

Who can join the trial?

10 criteria

You must have been newly diagnosed with **Crohn's disease** or have a flare-up of the disease.
You should be visiting the outpatient clinic or endoscopy ward of the participating centers.
Your **Crohn's disease** diagnosis must follow ECCO guidelines, which are expert recommendations for managing the disease.
You need to have had a complete **ileocolonoscopy** (a test to look inside the large intestine) within the last 12 months before the screening.
You must have had complete small bowel imaging at diagnosis, using either **MRI** (a type of scan that uses magnets and radio waves) or **CT-enterography** (a special type of CT scan that looks at the small intestine).
You should not have used **biologicals** before. Biologicals are a type of medication made from living organisms.
You must be between 18 and 70 years old.
You need to have sufficient knowledge of the Dutch language.
You must have a smartphone with internet access.
You should already be using **myIBDcoach** or be willing to start using it. **myIBDcoach** is a tool to help manage inflammatory bowel disease.

Who cannot join the trial?

3 criteria

Patients who have a different condition than Crohn's disease cannot participate.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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University Hospital Maastricht
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Maastricht, The Netherlands

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Investigated drugs

Adalimumab
is a medication used in this study as an initial treatment for patients newly diagnosed with Crohn's disease. It is administered periodically to help reduce inflammation and manage symptoms of the disease. The study aims to evaluate its long-term effectiveness and safety when used as a first-line treatment.
Corticosteroids
are used in the study as part of the standard step-up care for Crohn's disease. These medications help reduce inflammation and suppress the immune system to control symptoms. They are typically used when other treatments are not effective.
Budesonide
is another medication included in the standard step-up care for Crohn's disease in this study. It is a type of corticosteroid that targets the digestive tract to reduce inflammation and manage symptoms. It is often used as an initial treatment option.

Adalimumab

What is already known about the treatment

Adalimumab – This medication is administered via subcutaneous injection and is currently being studied for its effectiveness and safety as a first-line treatment for Crohn's disease. It is well-documented in medical literature as a treatment for various inflammatory conditions. Adalimumab works by blocking a protein called tumor necrosis factor (TNF), which plays a role in inflammation. It is classified as a TNF inhibitor and is used to reduce inflammation and manage symptoms in patients with autoimmune diseases.

Investigated diseases

Crohn's disease – Crohn's disease is a chronic inflammatory condition that primarily affects the gastrointestinal tract. It can involve any part of the digestive system, from the mouth to the anus, but most commonly affects the end of the small intestine and the beginning of the colon. The inflammation can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The disease often progresses with periods of flare-ups and remissions, where symptoms may improve or disappear for a time. Over time, Crohn's disease can lead to complications such as strictures, fistulas, and malnutrition. The exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.