A randomised, double-blind, multicentre study comparing the efficacy, safety and immunogenicity of proposed Abatacept biosimilar (DRL_AB) with Orencia® administered by the intravenous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis
This research study is looking at a new medicine for rheumatoid arthritis, called DRL_AB. It's being compared to an existing medicine called Orencia (abatacept), which is already approved and used. Both medicines are given through a drip (intravenously) alongside another common arthritis medicine, methotrexate. The main goal is to check if DRL_AB is as effective as Orencia in improving symptoms in people with moderate to severe rheumatoid arthritis over 13 weeks. Researchers will also be carefully watching for any side effects and how the body's immune system reacts to the new medicine. This is a large study (Phase III) involving many centres to get a clear picture of how DRL_AB works in a wider group of patients.
At a glance
What is this study about?
This study is about a type of medicine used for rheumatoid arthritis. Rheumatoid arthritis is a condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness. One of the treatments for this is a medicine called Orencia, which helps calm down the overactive immune system. Scientists are always working to make medicines more accessible, and sometimes they create 'biosimilar' versions of existing medicines.
A biosimilar medicine is very much like an approved medicine, but it's not identical. Think of it like different brands of a similar product – they work in the same way. In this study, they are testing a proposed biosimilar called DRL_AB against Orencia. Both these medicines are given through a drip into a vein and are used in combination with another common rheumatoid arthritis medicine called methotrexate.
The main purpose of this study is to see if DRL_AB is just as good as Orencia at improving rheumatoid arthritis symptoms. They will be looking closely at how much people's symptoms improve over 13 weeks. Researchers will also be checking very carefully for any side effects and how people's bodies react to the new medicine. This kind of study, called a Phase III trial, is a crucial step to prove that new medicines are safe and effective before they can be more widely used.
Key takeaways
- This study compares a new version, DRL_AB, with an existing rheumatoid arthritis medicine, Orencia.
- Both medicines are given by drip and used with methotrexate for moderate to severe rheumatoid arthritis.
- The main goal is to see if DRL_AB is as effective and safe as Orencia.
- You won't know which medicine you receive to keep the study fair.
- Researchers will closely monitor your symptoms, side effects, and overall health.
- Results will help decide if DRL_AB can become another treatment option.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or over. This study is open to both men and women.
You would also need to have been diagnosed with moderate to severe rheumatoid arthritis. The study medications will be given alongside methotrexate, so it's likely you would need to be suitable for or already taking methotrexate.
There will be other detailed health checks to make sure the study medication is safe for you. These might include reviewing other health conditions you have, or any other medicines you are taking. You will need to discuss all your medical history with the study team to see if you can take part.
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 able to take methotrexate?
- Are you willing to attend regular clinic visits?
- Are you comfortable with receiving medicine through a drip?
What does participation involve?
If you join this study, you will receive either the new medicine (DRL_AB) or Orencia, both given through a drip into your arm. You won't know which one you are getting, and neither will your study doctor, as this helps keep the results fair. You will also continue to take your methotrexate as prescribed.
Throughout the study, you'll have regular visits to the clinic. These visits will involve various checks, such as physical exams, blood tests, and questionnaires, to see how your rheumatoid arthritis is responding to the treatment and to monitor your general health. Researchers will also keep a close eye on any side effects you might experience. The study will last for a specific period to properly assess the effects of the medicines, with changes primarily measured over 13 weeks, but assessments will continue for longer.
Potential risks and benefits
Locations (8)
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedLatvia
- —UnverifiedLithuania
- —UnverifiedEstonia
- —UnverifiedRomania
Common questions
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term condition where your body's immune system attacks its own tissues, primarily affecting the joints, leading to pain, swelling, and stiffness.
What is a biosimilar medicine?
A biosimilar medicine is a very similar version of an existing, approved biological medicine. It works in the same way to treat the same conditions.
What does 'intravenous' mean?
Intravenous means the medicine is given directly into a vein, usually through a drip in your arm.
What is 'double-blind' in a study?
Double-blind means that neither you nor your study doctor will know whether you are receiving the new medicine or the existing one. This helps ensure fair and unbiased results.
Can I stop participating in the study?
Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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