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

3 1 1 1

What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.09.2019

Trial locations

Investigated drugs:

Adalimumab

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.

Investigated diseases:

Crohn's disease

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.

Trial ID:

2024-516002-33-01

NCT ID:

NCT03917303

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?