Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

This research study is focused on a medicine called Jyseleca for people living with rheumatoid arthritis. It's an ongoing study designed to understand how safe and effective Jyseleca is when taken for a long time. People taking part will receive either 100mg or 200mg tablets of Jyseleca. The main goal is to carefully check for any side effects and to see how well the medicine helps with arthritis symptoms. This involves regular health checks, blood tests, and monitoring vital signs like blood pressure. It's a 'Phase III' study, which means it's one of the final stages of testing before a medicine can be widely used.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Alfasigma S.p.A.

Enrolment target

254

Start

11 Jul 2024

Rheumatoid arthritis

What is this study about?

This research study is about a medicine called Jyseleca, which is being investigated for treating rheumatoid arthritis. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. This particular study is designed to gather more information about Jyseleca's long-term effects, focusing on how safe it is and how well it helps people manage their condition over an extended period. It’s an 'open-label' study, meaning both you and your study doctor will know which dose of Jyseleca you are receiving.

Participants in the study will be given either 100mg or 200mg tablets of Jyseleca. The main aim is to carefully monitor your health and well-being. This includes looking for any unexpected effects, often called 'adverse events,' and regularly checking your blood and other body functions through tests. Doctors will also keep an eye on your vital signs, like your heart rate and blood pressure, to ensure your health is stable.

By collecting this information, researchers hope to build a complete picture of Jyseleca's safety profile and its ability to reduce the activity of rheumatoid arthritis. This type of study, known as 'Phase III,' is crucial for understanding how new treatments work in real-world settings over time, helping to make sure medicines are both helpful and safe for people who need them.

Key takeaways

This study is testing the long-term safety and effectiveness of Jyseleca for rheumatoid arthritis.
Participants will receive Jyseleca tablets (100mg or 200mg).
Your health will be closely monitored with regular checks, blood tests, and vital signs.
This is a 'Phase III' study, a late stage of research before potential wider use.
You must be at least 18 years old to participate.
Taking part means you'll have frequent medical follow-ups.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to people of all genders.

Beyond these basic requirements, you would typically have been involved in a previous study using Filgotinib (the active ingredient in Jyseleca) due to the 'long-term extension' nature of this research. This means the study is designed for people who have already started treatment with this medication.

Your study doctor will be able to check your full medical history and current health to make sure this particular study is the right fit for you and that taking part would be safe.

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 rheumatoid arthritis?
Have you previously taken part in a study involving Filgotinib/Jyseleca?
Are you able to attend regular clinic visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either 100mg or 200mg tablets of the study medicine, Jyseleca, to take regularly as instructed. You will have a number of visits to the study clinic or hospital. These visits are important for the study team to monitor your health closely.

During these visits, you can expect to have blood tests, have your blood pressure and heart rate checked, and discuss any changes in your health or any side effects you might be experiencing. The medical team will also ask questions about your arthritis symptoms to see how the treatment is working.

The total amount of time you will be involved in this study will depend on the study design and your individual circumstances, as it is a long-term extension study. Your doctor will explain the full schedule of visits and assessments to you before you agree to participate.

Potential risks and benefits

Taking part in this study might offer you access to a potential treatment for your rheumatoid arthritis that is still being investigated. You will also receive very close medical attention and monitoring from a dedicated healthcare team. However, as with any medicine, Jyseleca could have side effects, which the study team will monitor carefully. There might also be inconvenient aspects to participating, such as travel to clinic visits or the time required for assessments. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Bulgaria
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Unverified
Hungary
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Unverified
Germany

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. It's an autoimmune disease, meaning your body's immune system mistakenly attacks your own tissues.

What is Jyseleca?

Jyseleca is the brand name of a medicine (filgotinib) being studied for treating rheumatoid arthritis. It's a type of drug that works on the immune system to reduce inflammation.

What does 'Phase III' mean?

Phase III means this is one of the final stages of testing for a new medicine. It involves a larger number of people to confirm its safety and effectiveness before it can be approved for wider use.

Will I know if I'm getting the active medicine?

Yes, this is an 'open-label' study, which means both you and your study doctor will know that you are receiving Jyseleca and what dose you are on.

What happens if I experience side effects?

The study team will monitor you very closely for any side effects. You should report any new or worsening symptoms immediately to the study staff, who will provide appropriate care and advice.