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Study Comparing Azathioprine and Methotrexate with Adalimumab for Patients with Crohn's Disease

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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 study aims to compare the effectiveness of two medications, azathioprine and methotrexate, when used in combination with another medication called adalimumab. Azathioprine is taken as a film-coated tablet, while methotrexate is administered as a solution for injection. Adalimumab is also given as a solution for injection.

The purpose of the study is to evaluate how well these combinations work in reducing the inflammation caused by Crohn's Disease. Participants in the study will receive either azathioprine or methotrexate along with adalimumab. The study will observe the participants over a period of time to see how their condition responds to the treatment. This includes regular check-ups and monitoring of symptoms to assess the effectiveness of the medication combinations.

Throughout the study, participants will be monitored for any changes in their condition, including improvements or any side effects. The study will also track the need for any adjustments in the adalimumab dosage and any potential withdrawal from the medications. The goal is to find out which combination of treatments provides the best results for managing Crohn's Disease.

The research process

The trial runs in 7 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 is conducted to confirm eligibility. This includes verifying a diagnosis of Crohn's Disease for at least 6 weeks, with active inflammation confirmed by endoscopy.
Eligibility criteria also require a Crohn's Disease Activity Index (CDAI) score greater than 150 and a history of non-response or intolerance to conventional therapies.
Step 2
Treatment allocation
Participants are randomly assigned to receive either azathioprine or methotrexate in combination with adalimumab.
Azathioprine is administered orally in the form of a film-coated tablet, while methotrexate is given as a subcutaneous injection.
Step 3
Medication administration
Adalimumab is administered as a subcutaneous injection. The dosage and frequency are determined by the study protocol and adjusted as necessary during follow-up visits.
Participants continue their assigned treatment regimen throughout the study duration, with regular monitoring and adjustments as needed.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor clinical response and remission. These visits occur at specified intervals, including weeks 12, 26, 52, 78, and 104.
During these visits, assessments include clinical evaluations, blood tests for C-reactive protein (CRP) and calprotectin levels, and endoscopic examinations.
Step 5
Endoscopic evaluation
An endoscopic evaluation is conducted at week 26 to assess the primary endpoint, which is a decrease of at least 50% in the Simple Endoscopic Score for Crohn's Disease (SES-CD) compared to baseline.
Secondary endpoints include endoscopic remission and ulcer-free endoscopy.
Step 6
Monitoring and adjustments
Throughout the study, the necessity for adalimumab optimization is evaluated, and adjustments are made as required.
Participants are monitored for any adverse events, and medication withdrawal is considered if necessary.
Step 7
Study completion
The study is estimated to conclude by September 2027, with final assessments conducted to evaluate long-term outcomes and any necessary follow-up care.

Who can join the trial?

7 criteria

Male or female patients who are older than 18 years.
Have had Crohn's Disease for at least 6 weeks.
Have a Clinically Active Disease Index (CDAI) score greater than 150. This score helps measure the activity of Crohn's Disease.
Show active inflammation in the intestines as seen through an endoscopy. An endoscopy is a procedure where a doctor uses a camera to look inside the digestive tract. The score should be 6 or more, or 4 or more if the disease is only in the ileum, which is the last part of the small intestine.
Have not responded to usual treatments like steroids or immunosuppressants, or cannot take these treatments due to side effects or other medical reasons, and are starting treatment with adalimumab. Adalimumab is a medication used to reduce inflammation.
Are being treated at a center that is part of the GETAID network, which is a group of centers specializing in digestive diseases.
Fertile men and women who can have children must use effective birth control methods as recommended by the study guidelines.

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Verified sites

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

Verified
Besancon University Hospital Center
Besançon, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
Centre Hospitalier De La Cote Basque
Bayonne, France

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Investigated drugs

Azathioprine
is a medication used to suppress the immune system. In this trial, it is being tested to see how well it works when combined with another medication, adalimumab, for treating Crohn's Disease. The goal is to see if it helps reduce inflammation in the intestines.
Methotrexate
is another medication that suppresses the immune system. It is being compared to azathioprine in this trial to determine which one is more effective when used with adalimumab for treating Crohn's Disease. The focus is on its ability to help heal the lining of the intestines.
Adalimumab
is a medication that helps reduce inflammation by blocking a specific protein in the body. It is commonly used to treat Crohn's Disease and is being used in this trial in combination with either azathioprine or methotrexate to see which combination works better in improving the condition of the intestines.

What is already known about the treatment

Azathioprine
Azathioprine is taken orally in tablet form and is used to treat Crohn's Disease. It is well-established in medical literature as an immunosuppressant. The medication works by interfering with the synthesis of DNA, which reduces the activity of the immune system. It is classified as an antimetabolite.
Methotrexate
Methotrexate is administered either orally or by injection and is used for managing Crohn's Disease. It is recognized in medical literature as a disease-modifying antirheumatic drug (DMARD). Methotrexate acts by inhibiting the enzyme dihydrofolate reductase, which is crucial for DNA synthesis, thereby suppressing the immune response. It belongs to the class of antimetabolites.
Adalimumab
Adalimumab is given by subcutaneous injection and is used to treat Crohn's Disease. It is widely documented in medical literature as a biologic therapy. The drug works by blocking tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. It is classified as a TNF inhibitor.

Investigated diseases

Crohn's Disease – Crohn's Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in severity. Common symptoms include abdominal pain, diarrhea, weight loss, and fatigue. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn's Disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The disease can affect any part of the gastrointestinal tract from the mouth to the anus, but it most commonly affects the end of the small intestine and the beginning of the colon.