A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis
This research study is looking into a new medicine called Rosnilimab for adults aged 18 and up who have moderate to severe rheumatoid arthritis. The main goal is to find out if this new medicine can help improve symptoms like joint pain and swelling, and to check if it's safe to use. Some participants will receive the new medicine, while others will get a placebo – a treatment that looks the same but contains no active medicine. This helps researchers fairly compare how well Rosnilimab works. The study is particularly interested in how participants' symptoms change over 12 weeks, as measured by a specific health score (DAS28-CRP). It’s a ‘Phase 2’ study, meaning it’s an earlier step in testing new medicines.
At a glance
What is this study about?
This study is a research project focusing on a new potential medicine named Rosnilimab. It's designed for people who have been diagnosed with rheumatoid arthritis that is considered moderate to severe. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. The aim of this study is to see if Rosnilimab can help reduce these symptoms and improve a person's overall quality of life, and importantly, to check its safety profile.
To make sure the results are as clear and unbiased as possible, the study involves comparing Rosnilimab with a 'placebo'. A placebo is a treatment that looks exactly like the real medicine but doesn't contain any active drug. Neither the participants nor the doctors will know who is receiving Rosnilimab and who is receiving the placebo – this is called 'double-blind'. This method helps researchers accurately determine if any improvements are due to Rosnilimab itself, rather than other factors.
The researchers will be monitoring various aspects of participants' health, especially changes in their rheumatoid arthritis symptoms over 12 weeks. They will be looking at specific scores that measure joint tenderness, swelling, and overall disease activity. They will also be tracking how many people show significant improvement or reach low levels of disease activity. This information will help decide if Rosnilimab could be a promising new treatment option in the future.
Key takeaways
- This study is for adults (18+) with moderate to severe rheumatoid arthritis.
- It's testing a new medicine called Rosnilimab against a dummy treatment (placebo).
- The main goal is to see if Rosnilimab is safe and helps reduce rheumatoid arthritis symptoms.
- You won't know if you're getting the medicine or placebo during the study.
- Participation involves regular visits to monitor your health over at least 12 weeks.
Who may be eligible?
To join this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.
Critically, you must have been diagnosed with rheumatoid arthritis that your doctor considers to be moderate to severe. This study is specifically for individuals with this level of rheumatoid arthritis, as the researchers want to see how the new medicine affects these particular symptoms. Your medical history will be reviewed to make sure the study is a good fit for you.
- Are you 18 years old or older?
- Have you been diagnosed with rheumatoid arthritis?
- Is your rheumatoid arthritis considered moderate to severe by your doctor?
- Are you able to attend regular study appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive either the new medicine, Rosnilimab, or a placebo (a dummy treatment). Both would be given as a clear solution. You would have regular visits over a 12-week period where the study team would check your health, assess your rheumatoid arthritis symptoms, and monitor for any side effects. These assessments might include physical exams, blood tests, and filling out questionnaires about how you're feeling. The exact number and frequency of visits, as well as the total duration of your participation, would be explained in full detail before you make any commitment.
Potential risks and benefits
Locations (9)
- —Hungary
- —Slovakia
- —Spain
- —Belgium
- —France
- —Italy
- —Germany
- —Poland
- —Estonia
Common questions
What is Rosnilimab?
Rosnilimab is a new medicine being tested for rheumatoid arthritis. It is not yet available as a standard treatment.
What is 'moderate to severe' rheumatoid arthritis?
This means your rheumatoid arthritis symptoms like pain, swelling, and stiffness are significantly affecting your daily life and haven't fully responded to typical treatments.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is over. This helps ensure fair results.
How long does the study last?
The main part of the study focuses on changes over 12 weeks, but your full involvement might be longer. The exact duration will be explained by the study team.
Can I stop participating if I want to?
Yes, you are free to leave the study at any time, for any reason, without it affecting your standard 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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