A Prospective Multicenter Randomized Controlled, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn’s Disease ( Direct-CD)
This study is for people with moderate to severe Crohn's disease and is testing a treatment called Remsima, which is given as an injection under the skin. Researchers want to find out the best way to use Remsima: either by itself or alongside other medications that help calm the immune system. They will be checking if the treatment helps patients feel better, reduces their symptoms without needing steroids, and heals inflammation in the gut. This is a later-stage study, meaning the treatment has already been used and found safe. The aim is to understand how well these different treatment approaches work over time for people living with Crohn's disease.
At a glance
What is this study about?
Crohn's disease is a condition where parts of your digestive system become inflamed, leading to symptoms like tummy pain, diarrhoea, and tiredness. For many, managing these symptoms and dealing with flare-ups can be challenging.
This study is called 'Direct-CD' and focuses on a medicine called Remsima. Remsima is a type of treatment that helps reduce the inflammation in your gut. It's given as an injection under your skin, which is a convenient way to get the medicine. The main purpose of this study is to compare two ways of using Remsima: one group of patients will receive Remsima on its own, and another group will receive Remsima along with other medicines that help suppress the immune system. These extra medicines are sometimes used to help treatments like Remsima work better and for longer.
Researchers want to see which of these approaches is more effective in helping people with Crohn's disease feel better and get their disease under control. Specifically, they are looking to see if the treatment can help people go into 'remission' – meaning their symptoms are much improved or gone, and there are signs of healing in their gut, all without needing to take steroid medications. Steroids can be helpful for flare-ups but often have side effects with long-term use. This study is an important step in understanding how to best use Remsima to improve the lives of people with Crohn's disease.
Key takeaways
- This study is for adults with moderate to severe Crohn's disease.
- It tests Remsima injections, either alone or with other medicines.
- The goal is to find the best way to reduce symptoms and heal the gut without steroids.
- Participation involves regular clinic visits for about six months.
- You'll be closely monitored, and your doctor will discuss potential benefits and risks.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or older. The study is open to both men and women.
Beyond these basic requirements, the study is looking for individuals who have been diagnosed with moderate to severe Crohn's disease that, despite current treatments, is still causing significant symptoms or gut inflammation.
There will be other, more detailed health checks to make sure the study treatment is suitable and safe for you. These might include reviewing your medical history, recent test results, and any other medications you are currently taking. The study team will discuss all these criteria with you during a screening visit.
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?
- Have you been diagnosed with moderate to severe Crohn's disease?
- Are you able to attend regular clinic appointments for about six months?
- Are you willing to potentially receive either Remsima alone or Remsima with another immune-suppressing medicine?
What does participation involve?
If you decide to take part, you would receive the study medication, Remsima, injected under your skin. Depending on which group you are in, you might also take another immune-suppressing medicine. You would have regular visits to the study clinic over about six months (26 weeks) to monitor your health and how you're responding to treatment. These visits would include check-ups, blood tests, and possibly endoscopies (a procedure to look inside your gut).
The total duration of dedicated study visits and active treatment would be around 26 weeks. After this, there might be follow-up observations. All study-related medication and assessments would be provided by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is Remsima?
Remsima is a medicine that helps reduce inflammation in the gut for people with Crohn's disease.
How is Remsima given?
It's given as an injection under the skin, similar to how some people might give themselves insulin.
What does 'corticosteroid-free remission' mean?
It means your Crohn's disease symptoms are well controlled, and your gut is healing, without you needing to take steroid medicines.
How long will the study last?
The main treatment and assessment period for the study is about 26 weeks, or roughly six months.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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