Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Prospective, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of MB04 and EU-sourced Enbrel® in Patients with Moderate to Severe Rheumatoid Arthritis.

This important study is designed to compare a new medicine, MB04, with an established treatment called Enbrel. Both medications are used for adults who have moderate to severe rheumatoid arthritis. The main goal is to find out if MB04 is just as effective as Enbrel in relieving symptoms over 24 weeks, and to make sure it's safe to use. Researchers are also looking at how the body handles the new medicine and if the body's immune system reacts to it. By comparing these two treatments, we can learn if MB04 could be another helpful option for managing rheumatoid arthritis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Mabxience Research S.L.

Enrolment target

548

Start

30 Aug 2024

Rheumatoid Arthritis

What is this study about?

This study is looking at a new medication, let's call it MB04, and comparing it to a treatment that many people with rheumatoid arthritis already use, called Enbrel. Rheumatoid arthritis is a condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness. Both MB04 and Enbrel are given as injections.

The main aim of this study is to see if MB04 works just as well as Enbrel in helping to reduce your arthritis symptoms. This includes looking at things like how many swollen and tender joints you have, and your overall well-being. We also need to make sure that MB04 is safe to use and doesn't cause too many side effects. This kind of research is very important because it helps us find new or better ways to manage long-term conditions like rheumatoid arthritis.

Participants in the study will be given either MB04 or Enbrel, but neither you nor your doctor will know which one you are receiving. This is a common way to conduct studies and helps ensure the results are as fair and accurate as possible. By gathering detailed information over several months, we can determine if MB04 is a good option for future treatment.

Key takeaways

This study compares a new drug (MB04) with an existing one (Enbrel) for rheumatoid arthritis.
It aims to see if MB04 is as effective and safe as Enbrel.
Participants will receive injections of one of the medications.
The study involves regular clinic visits and health checks over several months.
You will not know which specific treatment you are receiving.
It's for adults aged 18 and over with moderate to severe rheumatoid arthritis.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

You should have rheumatoid arthritis that is considered moderate to severe. This means your arthritis is causing you significant symptoms and discomfort.

There might be other specific health requirements or conditions that would mean you can't join the study, but these would be discussed in detail with your doctor if you are interested.

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 moderate to severe rheumatoid arthritis?
Are you able to attend regular clinic appointments for about 8-9 months?
Are you comfortable with receiving medication as an injection?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive regular injections of either the study medication (MB04) or the comparison medication (Enbrel) in a pre-filled syringe. You would have several visits to the clinic over a period of about 36 weeks (around 8-9 months). During these visits, the study team would:

* Check your general health. * Perform examinations to assess your rheumatoid arthritis symptoms, like counting swollen and tender joints. * Take blood samples to check how the medication is affecting your body and to look for specific markers related to your arthritis. * Ask you questions about how you're feeling and any changes in your symptoms.

There will also be follow-up assessments to see how you are doing after the main treatment period.

Potential risks and benefits

Taking part in a clinical trial may offer the chance to receive a new medication that could potentially improve your symptoms, or it could give you access to a standard treatment under close medical supervision. However, like all medications, both MB04 and Enbrel can have side effects, which the study team will discuss with you in detail. There's also no guarantee that the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland
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Unverified
Hungary
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Unverified
Bulgaria
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Unverified
Romania

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 multiple joints.

What is the new medicine, MB04?

MB04 is a new medicine being tested to see if it can help treat moderate to severe rheumatoid arthritis, similar to how Enbrel works.

What is Enbrel?

Enbrel is a well-established medication that is commonly used to treat rheumatoid arthritis and other conditions.

Will I know which medicine I am getting?

No, you and your study doctor will not know if you are receiving MB04 or Enbrel. This is to ensure the study results are fair and unbiased.

How long will the study last?

The main treatment and assessment period of the study will last for about 36 weeks, which is roughly 8 to 9 months.