A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety study of SAR441566 plus Methotrexate in Adults with Moderate to Severe Rheumatoid Arthritis
This research study is looking at a new drug called SAR441566 for adults who have rheumatoid arthritis that is moderate to severe and are already taking methotrexate. The main goal is to find out if this new medicine, when taken with methotrexate, can help improve symptoms like pain and swelling, and to check how safe it is. Participants will be randomly given either SAR441566 or a placebo (a dummy medicine) alongside their usual methotrexate. The study will look at how many people see a significant improvement in their arthritis symptoms after 12 weeks. Researchers will also be checking for any side effects and how the new medicine behaves in the body.
At a glance
What is this study about?
This study is about finding better ways to treat rheumatoid arthritis (RA). RA is a long-term condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness. We are testing a new medicine called SAR441566. This medicine is given in addition to methotrexate, which is a common RA treatment. The study is particularly for adults whose RA is considered moderate to severe, meaning their symptoms are quite noticeable and affect their daily life.
The main aim of this research is to see if SAR441566 can significantly improve how people with RA feel. We want to know if it helps reduce the signs and symptoms of RA. We'll be looking at specific measures, like how much your arthritis symptoms improve, and if you have fewer swollen or tender joints. An important part of the study is also to understand the potential side effects of SAR441566 and how well people tolerate it, which means how their bodies react to the treatment.
This is a 'Phase 2' study, which means we are still in the earlier stages of understanding this new medicine. We are looking closely at how effective it is and what the right dose might be, as well as gathering more information on its safety. By comparing SAR441566 to a placebo (a treatment that looks exactly like the study medicine but contains no active drug), we can get a clear picture of whether SAR441566 itself is making a difference.
Key takeaways
- This study is testing a new medicine (SAR441566) for moderate to severe rheumatoid arthritis.
- It's for adults already taking methotrexate.
- The main goal is to see if the new medicine improves symptoms and is safe.
- You might receive the new medicine or a dummy medicine (placebo).
- Participation involves regular clinic visits for 12 weeks.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 years or older, regardless of whether you are male or female. A key requirement is that you must have rheumatoid arthritis that is currently moderate to severe.
Another important point is that you should already be taking methotrexate, which is a standard medication for rheumatoid arthritis. The study aims to see if adding the new medicine, SAR441566, to your current methotrexate treatment can offer additional benefits. You will also need to meet other specific health criteria, which the study team will discuss with you.
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 moderate to severe rheumatoid arthritis?
- Are you currently taking methotrexate for your rheumatoid arthritis?
- Are you able to attend regular clinic visits for about 12 weeks?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to check if the study is right for you. If you qualify, you would be randomly assigned to receive either the new medicine (SAR441566) or a placebo (a dummy medicine), alongside your current methotrexate treatment. You wouldn't know which one you are getting, and neither would the study doctors.
You would need to attend several clinic visits over a period of 12 weeks. These visits would involve regular check-ups, blood tests, and assessments of your rheumatoid arthritis symptoms. We would monitor how your symptoms are changing, check for any side effects, and measure how the study medicine is affecting your body. The study team will explain exactly what each visit involves and answer any questions you have.
Potential risks and benefits
Locations (6)
- —UnverifiedSlovakia
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedGreece
- —UnverifiedSpain
Common questions
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. It's an 'autoimmune' disease, meaning your body's immune system attacks healthy tissues by mistake.
What is methotrexate?
Methotrexate is a common medicine used to treat rheumatoid arthritis. It helps to reduce inflammation and slow down joint damage.
What does 'moderate to severe' rheumatoid arthritis mean?
This means your rheumatoid arthritis symptoms are quite noticeable, impacting your daily life, and may not be fully controlled by your current medication.
What does 'placebo' mean?
A placebo is a 'dummy' medicine that looks like the real study drug but doesn't contain any active ingredients. It's used to fairly compare the new medicine's effects.
Will I still take my regular methotrexate if I join the study?
Yes, if you join this study, you will continue to take your regular methotrexate alongside the new study medicine or placebo.
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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