Comparison of azathioprine to methotrexate in combination therapy with adalimumab in Crohn’s Disease: an open-label randomized controlled trial
This research study is for adults with Crohn’s disease. It’s comparing two commonly used medications, azathioprine (sometimes called IMUREL) and methotrexate (sometimes called METOJECT), when they are taken alongside adalimumab (also known as Humira). The main goal is to find out which combination is better at helping to heal the inflammation in the gut, as seen during an endoscopy. Researchers will be looking for a significant improvement in the gut lining after about six months. They will also track other things like how participants feel, if their symptoms improve, and if they need other treatments or hospital visits. This study is in its final phase (Phase III), meaning these treatments have already been tested for safety and are now being thoroughly compared for effectiveness.
At a glance
What is this study about?
This study is designed to help doctors understand the best way to treat Crohn's disease, a long-lasting condition that causes inflammation in your digestive system. Many people with Crohn's take a medicine called adalimumab (brand name Humira), which is a type of 'biologic' medication that works by targeting specific parts of your immune system. Sometimes, other medicines are given alongside adalimumab to make it work better or last longer.
This research is comparing two of these 'add-on' medicines: azathioprine (brand name IMUREL) and methotrexate (brand name METOJECT). Both are commonly used, but doctors want to know which one is more effective when combined with adalimumab. The main thing they'll be looking for is how much the inflammation in your gut heals over time, especially after about six months. This healing will be checked using an endoscopy, where a small camera is used to look inside your digestive tract.
Ultimately, the goal of this study is to find out which combination of medicines gives people with Crohn's disease the best chance of feeling better and having their gut inflammation heal. This could lead to improved treatment plans for many patients in the future. By taking part, you could contribute valuable information to help others living with Crohn's disease.
Key takeaways
- Compares two common medicines (azathioprine and methotrexate) when used with adalimumab for Crohn's disease.
- Aims to find which combination best helps heal inflammation in the gut.
- Involves regular check-ups, blood tests, and endoscopies over about two years.
- For adults aged 18 and over with Crohn's disease.
- Could help improve future treatment plans for people with Crohn's.
Who may be eligible?
This study is looking for adults aged 18 years and older. There's no upper age limit, and both men and women can take part.
To be eligible, you would need to have a confirmed diagnosis of Crohn's disease. The researchers will look at your medical history and current health to make sure the study is a safe and suitable option for you.
There will also be specific health criteria that you'd need to meet. For example, they might check your current medications, how active your Crohn's disease is, and if you have any other serious health conditions that could affect the study results or your safety.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of Crohn's disease?
- Are you comfortable with regular hospital visits and medical tests?
- Are you able to take the study medications as prescribed?
What does participation involve?
If you decide to join this study, you would receive either azathioprine or methotrexate, along with your adalimumab. Both azathioprine and methotrexate are usually taken as tablets or injections, and adalimumab is given as an injection.
You would have several visits to the clinic over a period of about two years. During these visits, the study team would monitor your health, check your symptoms, and take blood tests. You would also have endoscopies to look at the healing in your gut, particularly around six months into the study.
The total duration of your participation would be just over two years, with regular check-ups to make sure the treatment is working and that you are safe and well.
Potential risks and benefits
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Common questions
What is Crohn's disease?
Crohn's disease is a condition that causes inflammation in your digestive system, leading to symptoms like tummy pain, diarrhoea, and weight loss.
What are azathioprine and methotrexate?
These are medicines commonly used alongside other treatments for Crohn's disease to help reduce inflammation and control symptoms.
What is adalimumab (Humira)?
Adalimumab is a 'biologic' medicine that targets specific parts of your immune system to help reduce inflammation in Crohn's disease.
What is an endoscopy?
An endoscopy is a procedure where a thin, flexible tube with a camera is used to look inside your digestive tract to check for inflammation or healing.
How long will the study last?
If you join, your participation in the study would last for just over two years.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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