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A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

This study is gathering information on the real-world experiences of people in the UK who are prescribed a new treatment called BRIUMVI® (ublituximab-xiiy) for a type of multiple sclerosis (MS) known as relapsing MS. Instead of being a traditional trial where people are given a new medicine for the first time, this is an 'observational' study. This means participants will already be receiving BRIUMVI® as part of their regular medical care. The main goal is to understand how safe and effective the medicine is in everyday situations, and to learn about people's experiences with it outside of a strict clinical trial environment. This helps doctors and researchers get a better picture of the treatment's impact on patients' lives.

At a glance

Status
Recruiting
Sponsor
TG Therapeutics, Inc.
Enrolment target
2,000
Start
22 Jul 2024
Estimated completion
01 Apr 2032

What is this study about?

Imagine a new medicine that has been tested in very controlled studies. Now, doctors and researchers want to see how it works for people in their daily lives, outside of those strict conditions. That's exactly what this study is about. It focuses on a medicine called BRIUMVI® (ublituximab-xiiy), which is used to treat a type of multiple sclerosis called Relapsing Multiple Sclerosis (RMS). RMS is a condition that affects your brain and spinal cord, causing different symptoms at different times.

This isn't a study where you would be given a new medicine to try for the first time. Instead, it's for people who have already been prescribed BRIUMVI® by their doctor for their MS. The study wants to collect information from these patients about their experiences. This helps doctors and scientists understand how the medicine is working in the real world, how safe it is, and what it's like for people to take it.

By gathering this 'real-world' information, the study aims to build a more complete picture of BRIUMVI®. This helps to make sure that treatments are as safe and effective as possible for everyone. It's an important step in understanding how new medicines perform once they are in regular use.

Key takeaways

  • This study gathers real-world information on BRIUMVI® for relapsing MS.
  • It's for people already prescribed BRIUMVI® by their doctor.
  • You won't receive extra medication or change your MS treatment plan.
  • No extra hospital visits are needed, information comes from your regular care.
  • Your participation helps doctors understand the medicine's effects in daily life.
  • You can stop participating at any time without affecting your care.

Who may be eligible?

To be part of this study, you need to meet a few simple criteria. First, you must have been officially diagnosed with Multiple Sclerosis (MS), specifically the 'relapsing' type. Second, you must have been prescribed BRIUMVI® by your doctor. You can join the study even if you haven't had your first dose yet, as long as you are about to start it.

However, there are some reasons why you might not be able to join. For example, if you've recently had certain types of vaccines (like live vaccines within the last 4 weeks or non-live vaccines within the last 2 weeks), you wouldn't be able to take part. Also, if you have an active infection, such as Hepatitis B, you wouldn't be eligible.

Finally, if you're already involved in another study looking at MS treatments, or if you're planning to take other MS modifying treatments at the same time as BRIUMVI®, then this study wouldn't be right for 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.

  1. I have been diagnosed with Relapsing Multiple Sclerosis (RMS).
  2. My doctor has prescribed me BRIUMVI® (ublituximab-xiiy).
  3. I haven't had certain types of vaccines recently (live vaccines within 4 weeks, non-live within 2 weeks).
  4. I don't have an active infection like Hepatitis B.
  5. I'm not currently in another MS treatment study or planning to take other MS modifying treatments at the same time.
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll simply be receiving your BRIUMVI® medicine as your doctor has already prescribed it. This study does not involve giving you a new or different medicine. It also doesn't change how you would normally take your medicine or how often you see your doctor for your MS. Because this is an 'observational' study, it means researchers will gather information about your health and your experience with BRIUMVI® from your medical records and possibly through some questionnaires.

There are no specific extra visits to a clinic just for this study. The study team will collect information during your regular doctor appointments or by checking your medical notes. The total length of your participation would depend on how long your doctor plans for you to take BRIUMVI® and for how long the study decides to collect information. You won't be asked to do anything unusual or extra apart from what your doctor would normally recommend for your MS treatment.

Potential risks and benefits

A potential benefit of joining this study is contributing valuable information that helps doctors and researchers understand the real-world effects of BRIUMVI® for people with relapsing MS. This could lead to better care for future patients. Since you're already taking the medicine as prescribed by your doctor, there are no extra medical risks directly caused by participating in the study itself. However, as with any medicine, BRIUMVI® has its own known risks and side effects, which your doctor would have discussed with you. Remember, taking part in any study is completely voluntary, and you are free to withdraw at any time without affecting your medical care.

Locations (111)

  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Birmingham, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Cullman, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Huntsville, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Mobile, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Gilbert, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Phoenix, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Scottsdale, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Fresno, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Newport Beach, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Orange, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    West Hollywood, United States· Recruiting
  • TG Therapeutics Investigational Trial Site
    Verified postcode
    Aurora, United States· Recruiting

Common questions

What is the main goal of this study?

The main goal is to understand how a medicine called BRIUMVI® works in real life for people with a type of MS, looking at safety and how effective it is.

Will I be given new medicine if I join?

No, you will only receive BRIUMVI® as prescribed by your own doctor. This study doesn't involve giving you a new or different treatment.

Do I need to visit the hospital more often for this study?

No, this study doesn't require extra hospital visits. Information will be collected during your regular appointments or from your medical records.

Can I leave the study at any time?

Yes, taking part is completely your choice, and you can decide to leave the study at any point without it affecting your medical care.

What type of MS is this study for?

This study is for people diagnosed with Relapsing Multiple Sclerosis (RMS).

How to find out more

TG Therapeutics Clinical Support Team

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study Evaluating the Real World Experience of Participants…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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