CO-THEIA (COMBINATION THERAPY WITH METHOTREXATE AND ADALIMUMAB FOR UVEITIS): EFFICACY, SAFETY AND COST-EFFECTIVENESS OF METHOTREXATE, ADALIMUMAB, OR THEIR COMBINATION IN NON INFECTIOUS NON ANTERIOR UVEITIS: A MULTICENTER, RANDOMIZED, PARALLEL 3 ARMS, ACTIVE-CONTROLLED, PHASE 3 OPEN LABEL WITH BLINDED OUTCOME ASSESSMENT STUDY.
This study is called CO-THEIA and aims to find the best way to treat a serious eye condition called non-infectious uveitis, where the body's immune system attacks the eye. Doctors are comparing three different treatments: methotrexate, adalimumab, and a combination of both. They want to see which one works best to reduce inflammation, improve vision, and is safest for patients. The study also checks the cost-effectiveness of these treatments. Information from this study will help doctors decide the most effective and appropriate treatment plans for people living with this type of uveitis.
At a glance
What is this study about?
Imagine your eye getting inflamed, not because of an infection, but because your body's own defense system mistakenly attacks it. This is what happens in a condition called non-infectious uveitis. It can cause pain, blurry vision, and if not treated, can lead to serious eye damage or even blindness.
Currently, doctors use different medicines to calm this inflammation. This study, called CO-THEIA, is a big research project looking at two main medicines: methotrexate and adalimumab. Methotrexate has been used for a while to reduce inflammation, and adalimumab is a newer type of medicine that specifically targets parts of the immune system. Previous studies have shown that these medicines can help.
In this study, researchers want to see if using both methotrexate and adalimumab together works better than using either medicine on its own. They will look at whether people achieve a 'Good Clinical Response', meaning their eye inflammation is under control and their vision is stable or improving. The study also explores how these treatments affect a person's quality of life, their vision, and how much they cost, to help make sure effective treatments are also good value for the healthcare system.
Key takeaways
- Compares two existing medicines, methotrexate and adalimumab, for uveitis.
- Aims to find out if combining the medicines works better.
- Focuses on non-infectious uveitis, where the body's immune system causes inflammation.
- Assesses how well treatments control inflammation, improve vision, and their safety.
- Also considers the cost and impact on quality of life.
- You will be randomly assigned to one of three treatment groups.
Who may be eligible?
To join this study, you must be at least 18 years old. The study is open to both men and women.
The main requirement is that you have a type of eye inflammation called 'non-infectious non-anterior uveitis'. This means your eye inflammation isn't caused by an infection, and it affects the middle or back parts of your eye, rather than just the front.
There will be other detailed checks by the study doctors to make sure the treatment is safe and suitable for your specific situation. This helps ensure that the study is as safe as possible for everyone taking part and that the results are reliable.
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 over?
- Do you have a type of non-infectious uveitis?
- Does your uveitis affect the middle or back of your eye?
- Are you able to attend regular hospital appointments for tests and check-ups?
What does participation involve?
If you decide to take part, you would be randomly assigned to one of three treatment groups: receiving methotrexate, receiving adalimumab, or receiving both together. This is a bit like drawing straws, ensuring fairness. You would take your assigned medication regularly as directed by the study team.
Throughout the study, you'll have regular hospital visits for eye exams, blood tests, and to fill out questionnaires about your vision, general health, and how you're feeling. These visits help the doctors track your progress, check for any side effects, and make sure the medication is working. The study team will provide more specific details about the number of visits and the full duration of follow-up required, but these types of studies typically involve regular check-ups over several months to a year or more.
Potential risks and benefits
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Common questions
What is 'non-infectious uveitis'?
It's a condition where your eye becomes inflamed because your body's immune system attacks it, not due to an infection.
What are methotrexate and adalimumab?
They are medicines used to calm down the overactive immune system that causes inflammation in conditions like uveitis.
Why is this study important?
It helps doctors understand if combining these two medicines works better than using them separately, to provide more effective treatment for uveitis.
How long does a study like this usually last?
Clinical trials can vary, but typically involve several months to over a year of follow-up to see how treatments work over time.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, meaning you and your doctors will know which treatment you are receiving.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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