A Phase 2a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Burfiralimab (hzVSF-v13) added to disease-modifying antirheumatic drugs in patient with moderate to severe Rheumatoid Arthritis
This research study is looking at a new medicine called Burfiralimab for people living with moderate to severe rheumatoid arthritis. The main goal is to find out if Burfiralimab, when taken alongside their current arthritis medicines, can help improve their symptoms and make them feel better overall. Participants will be randomly given either Burfiralimab or a liquid that looks the same but contains no active medicine (doctors call this a placebo). Neither the participant nor their doctor will know which treatment they are receiving. This helps us fairly compare the effects of the new medicine. We will be carefully monitoring participants for any changes in their condition and any side effects over 12 weeks.
At a glance
What is this study about?
This study is an important step in exploring new treatments for rheumatoid arthritis. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. It can affect anyone, but often starts between the ages of 40 and 50 and is more common in women.
Researchers are testing a medicine called Burfiralimab. They want to see if adding Burfiralimab to the usual arthritis medications (known as disease-modifying antirheumatic drugs, or DMARDs) can help people with moderate to severe rheumatoid arthritis feel better. This means looking at whether it can reduce their joint pain, swelling, and stiffness more effectively.
This is a 'Phase 2a' study, which means it's an early stage of testing. We're looking at how well the medicine works and if it's safe to use. Half the participants will receive Burfiralimab, and the other half will receive a dummy treatment called 'normal saline' (which is just salty water, used as a placebo). This helps researchers understand whether any improvements are due to the new medicine or other factors. Everyone involved, including the study staff and participants, won't know who is getting which treatment, which makes the results more reliable.
Key takeaways
- This study is testing a new medicine for moderate to severe rheumatoid arthritis.
- It aims to see if the new medicine, Burfiralimab, helps alongside current treatments.
- Participants will receive either Burfiralimab or a dummy treatment (placebo).
- It's a 12-week study, involving clinic visits for assessments.
- All health information will be kept confidential.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. The study is open to both men and women.
Crucially, you must have been diagnosed with rheumatoid arthritis, and your condition needs to be classed as 'moderate to severe'. This means your arthritis is significantly affecting your joints even with your current treatment.
There will be other health checks and requirements to make sure the study is safe for you and that the results will be clear. Your study doctor will go through all of these 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 rheumatoid arthritis?
- Is your rheumatoid arthritis considered moderate to severe?
- Are you currently taking disease-modifying antirheumatic drugs (DMARDs) for your arthritis?
What does participation involve?
If you decide to take part, you'll be assigned either Burfiralimab or a placebo (dummy treatment), like drawing lots, but done by computer. You will receive this treatment alongside your usual arthritis medicines. You won't know which one you're getting, and neither will your doctor.
The study will last for 12 weeks. During this time, you will have several visits to the clinic for check-ups. These visits will involve various assessments, such as physical examinations to check your joints, blood tests, and questionnaires about your pain, daily activities, and how you feel generally. This helps the researchers understand if the new medicine is making a difference and how it's affecting your quality of life.
Potential risks and benefits
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Common questions
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness.
What does 'Burfiralimab' mean?
Burfiralimab is the name of the new investigational medicine being tested in this study. It's a new type of treatment.
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine fairly.
What does 'double-blind' mean?
Double-blind means that neither you nor your study doctor will know whether you are receiving the new medicine or the placebo throughout the study.
How long will I be in the study?
Your active participation in the study will last for about 12 weeks.
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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