I4V-MC-JAJA (RA-BRIDGE): A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis
This study, called RA-BRIDGE, is for people with rheumatoid arthritis. Doctors are looking closely at a medicine called baricitinib. They want to compare it with other usual treatments for rheumatoid arthritis, such as adalimumab and etanercept. The main thing they're interested in is how long it takes for someone taking these medicines to experience a specific type of blood clot, known as a venous thromboembolism (VTE). This will help them understand the safety of baricitinib over a long period. This is a phase 3b/4 study, meaning it's testing a medicine that's already approved but gathering more information about its long-term effects and safety in a larger group of patients. Participants will be involved for about five and a half years.
At a glance
What is this study about?
This study, known as RA-BRIDGE, is focused on helping people living with rheumatoid arthritis. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. Doctors are constantly working to find treatments that are both effective at managing the condition and safe for patients over many years.
In this study, researchers are specifically looking at a medicine called baricitinib. It's already approved for treating rheumatoid arthritis, but scientists want to learn more about its long-term safety, especially when compared to other well-known medicines like adalimumab and etanercept that are also used for rheumatoid arthritis. The main thing they're tracking is how often a certain type of blood clot, called a venous thromboembolism (VTE), occurs in people taking these different treatments, and how long it takes for such an event to happen.
This kind of study helps doctors and patients make informed decisions about treatments. By carefully comparing baricitinib with other treatments over a long period, we can get a clearer picture of its risks and benefits. This information is important because it helps ensure that medicines prescribed for rheumatoid arthritis are as safe and effective as possible for everyone.
Key takeaways
- This study aims to understand the long-term safety of baricitinib for rheumatoid arthritis.
- It compares baricitinib with other common rheumatoid arthritis medicines.
- The main focus is on how often a type of blood clot (VTE) occurs with these treatments.
- The study will last for about five and a half years.
- It helps doctors make better treatment decisions for patients with rheumatoid arthritis.
Who may be eligible?
To join this study, you must be an adult aged 18 years or older, as the study is designed for adult patients with rheumatoid arthritis. There are no restrictions based on whether you are male or female; anyone can participate.
Beyond these basic requirements, doctors will need to check your medical history and current health carefully to make sure the study treatments are suitable and safe for you. They will also look at your current rheumatoid arthritis condition to see if it matches the study's specific needs.
It's important to remember that even if you meet the age and sex criteria, there might be other reasons why the study isn't right for you, such as other health conditions you might have or medicines you are currently taking. The study team will discuss all these details 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?
- Do you have a diagnosis of rheumatoid arthritis?
- Are you willing to commit to a study lasting over five years?
- Are you able to attend regular clinic visits and assessments?
What does participation involve?
If you decide to take part in this study, you would be involved for approximately five and a half years. During this time, you would receive one of the study medications: baricitinib, adalimumab, or etanercept. These medications would be given according to the study plan. You would have regular visits to the clinic where study doctors and nurses would perform various checks. These check-ups would include physical examinations, blood tests, and perhaps other assessments to monitor your health, how well the medicine is working, and to look for any side effects. These frequent visits allow the study team to keep a close eye on your health throughout the long study period.
Potential risks and benefits
Locations (15)
- —UnverifiedHungary
- —UnverifiedSlovakia
- —UnverifiedLithuania
- —UnverifiedAustria
- —UnverifiedFrance
- —UnverifiedGreece
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedDenmark
- —UnverifiedNetherlands
- —UnverifiedGermany
Common questions
What is rheumatoid arthritis?
Rheumatoid arthritis is a condition where your body's immune system attacks your own tissues, specifically the lining of your joints, causing pain, swelling, and stiffness.
What is baricitinib?
Baricitinib is a medicine used to treat rheumatoid arthritis. It works by calming down parts of your immune system that cause inflammation.
What is a venous thromboembolism (VTE)?
A VTE means a blood clot that forms in a vein, often in the leg (deep vein thrombosis) or that travels to the lungs (pulmonary embolism). This study is monitoring how often these occur.
How long will the study last?
The study will last for approximately five and a half years from the time you start taking the study medication.
Will I know which medicine I'm getting?
The study compares different medicines. Sometimes in these studies, participants don't know which specific medicine they are receiving until after the study is over, to ensure unbiased results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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