Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients with Active Crohn’s Disease or Ulcerative Colitis
This research is investigating a new way to deliver Remsima, a treatment used for inflammatory bowel diseases like Crohn's disease and ulcerative colitis. Currently, Remsima is given through a drip (infusion), but this study is testing it as a simple injection under the skin. The main goal is to understand how much of the medicine stays in your body after this injection and how effective it is in reducing symptoms. Researchers will also be checking its safety, looking for any side effects. This could potentially offer a more convenient way for people to receive their treatment in the future.
At a glance
What is this study about?
This study is about a treatment called Remsima, which is used for inflammatory bowel diseases (IBD) like Crohn's disease and ulcerative colitis. These are conditions where your gut becomes inflamed, causing symptoms like tummy pain, diarrhoea, and tiredness. Currently, Remsima is given as an infusion, meaning it’s delivered into your vein through a drip, which usually takes place in a hospital or clinic.
This research is exploring a new version of Remsima that can be given as an injection just under the skin, similar to a regular jab. This could potentially make it much easier for people to take their medication, possibly even at home, without needing to go to a clinic for a long infusion. The main thing the researchers want to find out is how much of the medicine (CT-P13) stays in your body after this new type of injection.
They also want to see how well the new injection works in reducing the symptoms of Crohn's disease and ulcerative colitis, checking for improvements in people's health and how they feel. Importantly, they will also be closely monitoring the safety of this new injection, looking for any side effects. The aim is to see if this new, more convenient way of taking Remsima is as good and safe as the current method.
Key takeaways
- This study is testing a new way to give Remsima medicine as an injection.
- It's for people with active Crohn's disease or ulcerative colitis.
- Researchers want to see if the injection works well and is safe.
- The study lasts about 24 weeks and involves regular clinic visits.
- Participation might offer a more convenient treatment method in the future.
- You can stop participating at any time without affecting your care.
Who may be eligible?
To be part of this study, you need to be at least 18 years old. The study is open to both men and women.
You must have been diagnosed with either Crohn's disease or ulcerative colitis, and these conditions must be active, meaning you are currently experiencing symptoms.
The health care team will check specific details about your medical history and current health to make sure this study is right and safe for you. They will explain all the requirements in detail.
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 or ulcerative colitis?
- Are your Crohn's disease or ulcerative colitis symptoms currently active?
- Are you able to attend regular clinic appointments for about 6 months?
What does participation involve?
If you join this study, you will receive doses of the study medication, Remsima, as an injection under your skin. The study will involve regular visits to the clinic over a period of 24 weeks (about 6 months).
During these visits, the research team will take blood samples to measure how much of the medicine is in your body and to check for any changes. They will also ask you to complete questionnaires about your symptoms and how you are feeling generally. You will have physical examinations, and they will collect stool samples to check for signs of inflammation.
They will also keep a close eye on any side effects you might experience, including reactions at the injection site. You have the right to withdraw from the study at any time.
Potential risks and benefits
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Common questions
What is Remsima?
Remsima is a medicine used to treat inflammatory bowel diseases like Crohn's disease and ulcerative colitis. It helps to reduce inflammation in the gut.
What is the difference between an infusion and an injection?
An infusion means the medicine is given slowly into a vein, usually with a drip. An injection in this study means the medicine is given just under your skin, like a flu jab.
Is this a new medicine?
Remsima itself is not new, but this study is looking at a new way to give it – as an injection under the skin instead of through a drip.
What is a 'clinical trial phase III'?
This means the treatment has already been tested in smaller groups and now it's being tested in a larger group of people to confirm its effectiveness and safety before it can be widely used.
What happens if I decide I don't want to be in the study anymore?
You are free to leave the study at any time, for any reason, and it will not 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.
Discussion
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