A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants with Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)
This research study, called LaunchPAD-RA, is looking into a new medicine called AZD1163 for adults suffering from rheumatoid arthritis that is moderate to severe. Rheumatoid arthritis is a condition where your immune system mistakenly attacks your joints, causing pain, swelling, and stiffness. We want to find out how well this new medicine works to improve these symptoms, and whether it has any side effects. Participants in the study will be randomly assigned to receive either AZD1163 or a placebo (a dummy medicine) for 12 weeks. Neither the patient nor their doctor will know which treatment they are receiving. We will then compare how much participants’ symptoms have improved and check for any safety concerns. This information will help us understand if AZD1163 could be a helpful new treatment option in the future.
At a glance
What is this study about?
This study, called LaunchPAD-RA, is testing a new medicine named AZD1163 for people who have rheumatoid arthritis. Rheumatoid arthritis is a condition where your body's immune system, which normally fights off infections, starts attacking healthy parts of your body, usually your joints. This can lead to pain, swelling, stiffness, and damage in your joints. The medicine we are testing, AZD1163, aims to calm down this overactive immune response and hopefully reduce these symptoms.
The main goal of this study is to see how much improvement people experience in their rheumatoid arthritis symptoms over 12 weeks. We'll be looking closely at a score called DAS28-CRP, which helps doctors measure how active the disease is based on your symptoms and blood tests. We also want to find out if AZD1163 is safe to use and what side effects it might have.
Understanding if AZD1163 can effectively reduce the symptoms of rheumatoid arthritis and is well-tolerated by patients is really important. If successful, this research could lead to a new treatment option for people living with this condition, helping them to manage their pain and improve their daily lives.
Key takeaways
- This study tests a new medicine for moderate to severe rheumatoid arthritis.
- It aims to see if the medicine works and is safe over 12 weeks.
- Participants will receive either the new medicine or a dummy medicine.
- You'll have regular medical checks and blood tests.
- Participation is voluntary, and you can leave at any time.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women. You must have been diagnosed with rheumatoid arthritis that is considered moderately to severely active.
This means that your current rheumatoid arthritis symptoms are causing significant problems, even if you're already taking other medicines. The study doctors will carefully check your medical history and do some tests to make sure that taking part is safe for you and that the study is the right fit.
There might be other specific reasons why you can't join, such as other serious medical conditions or certain medicines you are taking. The study team will discuss all these details with you during your initial visit.
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 currently moderate to severe?
- Are you able to attend regular clinic appointments for 12 weeks?
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance (like flipping a coin) to receive either the new medicine AZD1163 or a dummy medicine called a placebo. Neither you nor your study doctor will know which one you are receiving – this is to make sure the results are as fair as possible.
You will take the study medicine for 12 weeks. During this time, you'll need to attend regular clinic visits. These visits will involve blood tests to check your disease activity, see how the medicine is affecting you, and measure the level of AZD1163 in your blood if you are receiving it. You’ll also have physical exams where the doctor will check your joints and ask about your symptoms. We will also check for any side effects you might experience and look at how your body responds to the medicine over time. The total duration for your active participation in the study is 12 weeks, with some follow-up checks afterwards.
Potential risks and benefits
Locations (5)
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedBulgaria
- —UnverifiedGermany
- —UnverifiedPoland
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, usually in your hands and feet.
What is AZD1163?
AZD1163 is a new medicine being tested to see if it can reduce the symptoms of rheumatoid arthritis by calming down the overactive immune system.
What's a 'dummy medicine' (placebo)?
A dummy medicine, or placebo, looks exactly like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine to not having any active treatment.
Will I know if I'm getting the real medicine?
No, neither you nor your study doctor will know if you're getting AZD1163 or the dummy medicine. This is a common practice in research to make study results as accurate as possible.
How long will I be in the study?
You'll be taking the study medicine for 12 weeks, with regular visits during that time, plus some follow-up checks afterwards.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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