J1A-MC-KDAF: A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis
This research study is looking into a new treatment called peresolimab for adults who have rheumatoid arthritis that's moderate to severe. Rheumatoid arthritis is a condition where your body's immune system attacks your joints, causing pain, swelling, and stiffness. This trial is comparing peresolimab to a 'dummy' treatment (placebo) to see how well it works. The main goal is to find out if participants taking peresolimab see a 20% improvement in their arthritis symptoms, such as joint pain and swelling, compared to those taking the dummy treatment. This is an early-stage study to learn more about the medicine's effects.
At a glance
What is this study about?
This study is about exploring a new medicine called peresolimab for people living with rheumatoid arthritis. Rheumatoid arthritis is a long-term condition where your body's immune system mistakenly attacks its own tissues, particularly the lining of your joints. This can lead to pain, swelling, stiffness, and sometimes damage to the joints. Doctors call it an 'autoimmune disease' because your immune system – which normally fights off infections – turns against your own body.
The main aim of this study is to see if peresolimab can help reduce these symptoms in adults who have a moderate to severe form of the disease. To do this fairly, some people in the study will receive peresolimab, while others will receive a 'dummy' treatment, called a placebo. This means neither you nor your doctor will know which treatment you are getting, to make sure the results are as clear and unbiased as possible. The dummy treatment looks just like the real medicine but contains no active drug. The study is particularly interested in whether participants experience a 20% improvement in their arthritis symptoms, a measure commonly used in arthritis research.
This is an early-stage study, meaning it's one of the first times this medicine is being tested in a larger group of people with rheumatoid arthritis. The information gathered will help researchers understand if peresolimab is effective and safe enough to continue testing in bigger studies, potentially leading to a new treatment option for people with this condition.
Key takeaways
- Tests a new medicine (peresolimab) for rheumatoid arthritis.
- Compares peresolimab to a 'dummy' treatment (placebo).
- Aims to see if symptoms improve by at least 20%.
- Open to adults aged 18 and over with moderate to severe rheumatoid arthritis.
- Participation involves regular clinic visits for monitoring.
- You won't know if you're getting the active medicine or the placebo.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. There is no upper age limit, so people of all adult ages can be considered. The study is open to everyone, regardless of whether you are male or female.
The study is specifically looking for people who have been diagnosed with rheumatoid arthritis. Your arthritis must be considered 'moderately to severely active', meaning it's causing noticeable symptoms like pain, swelling, and stiffness, even possibly with your current treatments.
There might be other health requirements or conditions that would prevent someone from joining, even if they meet these basic criteria. These more detailed rules are put in place to ensure the safety of participants and the accuracy of the study results. Your study doctor can tell you more about all the specific criteria.
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 rheumatoid arthritis?
- Is your rheumatoid arthritis currently moderate to severe?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part in this study, you would receive either the new medicine, peresolimab, or a dummy treatment. You wouldn't know which one you are getting. You would have regular visits to a study clinic where a team of healthcare professionals would monitor your health and your arthritis. These visits would involve check-ups, answering questions about your symptoms, and possibly some blood tests to see how the medicine is affecting your body. The study might also involve physical examinations to look at your joints.
The medication would likely be given as an injection, but the exact details of how often and for how long the treatment lasts would be fully explained by the study team. Over the course of the study, your progress would be carefully tracked to see if your symptoms improve. After the main treatment period, there will be follow-up appointments to ensure your well-being and gather any final information. The total duration of your participation, including follow-up, would be fully explained to you before you agree to join.
Potential risks and benefits
Locations (5)
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Common questions
What is rheumatoid arthritis?
It's a long-term condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness.
What is peresolimab?
It's a new medicine being tested to see if it can help improve symptoms for people with rheumatoid arthritis.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you are receiving the new medicine or a dummy treatment, to keep the study fair.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug.
What does 'ACR20' mean?
It's a way doctors measure if your arthritis symptoms, like pain and swelling, have improved by at least 20%.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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