Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis
This study is an observational look at how a medicine called filgotinib works for adults in the UK who have moderate to severe rheumatoid arthritis. The researchers will be observing people who are already taking filgotinib as part of their usual care, rather than asking anyone to try new treatments. They want to understand how effective the medicine is for real patients, what side effects they experience, and how it impacts their daily lives and overall well-being. This information will be collected as people go about their normal treatment journey, helping doctors learn more about this medication in a real-world setting.
At a glance
What is this study about?
This study is about a medicine called filgotinib, which is used to treat a condition called rheumatoid arthritis (RA). RA is when your immune system, which normally fights off germs, mistakenly attacks the lining of your joints, causing pain, swelling, and stiffness. Filgotinib helps to calm down this immune system activity.
Instead of asking people to try a new medicine, this study is different. It’s an “observational” study, which means researchers will be simply watching and learning from people who are already taking filgotinib as part of their regular treatment for RA. They want to see how well the medicine works in real-world situations, outside of strict clinical trial settings. This includes how much it helps with symptoms, any side effects people might experience, and how it affects their daily lives and overall health.
The information gathered from this study will help doctors and researchers understand more about filgotinib. It will show how it performs for a wider range of patients and provide valuable insights into its benefits and any challenges when used in everyday healthcare. This knowledge can improve how RA is treated in the future.
Key takeaways
- This is an observational study for people taking filgotinib for rheumatoid arthritis.
- The study aims to understand the medicine's effectiveness and side effects in daily life.
- You will use an electronic device to share how you're feeling.
- Your routine medical care or prescribed medication will not change.
- Your participation helps improve future treatments for rheumatoid arthritis.
Who may be eligible?
To be able to take part in this study, you would need to be 18 years old or older. You must have been diagnosed with moderate to severe rheumatoid arthritis and be starting filgotinib for the first time as part of your usual treatment, and according to what your doctor has prescribed.
Also, you need to be willing and able to use an electronic device, like a tablet or smartphone, to answer some health questions throughout the study. This helps the researchers understand how you're feeling and how the medicine is affecting you.
Generally, you can't be in another clinical study at the same time, unless it's a national health registry and your current study doctor says it's okay. This helps ensure that the information collected is clear and only related to your experience with filgotinib.
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?
- Is your doctor prescribing filgotinib for you for the first time?
- Are you able to use a smartphone or tablet to answer questions?
- Are you not currently in another clinical study (unless approved)?
What does participation involve?
If you take part, the study will simply observe your progress while you take filgotinib as prescribed by your doctor. You won't be asked to change your medication or have extra medical procedures. You will be asked to regularly answer questions on an electronic device about how you are feeling, your symptoms, and any side effects. This is known as a patient-reported outcome (PRO). Your doctor will continue to monitor your health as usual. The total duration of your participation will depend on your treatment plan with filgotinib, but is typically a number of months while you are on the medication.
Potential risks and benefits
Locations (89)
- Algemeen Stedelijk ZiekenhuisVerified postcodeAalst, Belgium
- Imelda VZWVerified postcodeBonheiden, Belgium
- AZ Sint-Jan Brugge-OostendeVerified postcodeBruges, Belgium
- Hôpital ErasmeVerified postcodeBrussels, Belgium
- Cliniques Universitaires Saint-LucVerified postcodeBrussels, Belgium
- Grand Hôpital de Charleroi asblVerified postcodeCharleroi, Belgium
- UZ AntwerpenVerified postcodeEdegem, Belgium
- Reumacentrum GenkVerified postcodeGenk, Belgium
- Reumaclinic GenkVerified postcodeGenk, Belgium
- AZ Maria MiddelaresVerified postcodeGhent, Belgium
- Reuma InstituutVerified postcodeHasselt, Belgium
- UZ LeuvenVerified postcodeLeuven, Belgium
Common questions
What is an 'observational study'?
It means researchers are simply watching and learning from people already taking a medicine. You're not asked to try new treatments or do anything different from your usual care.
Will I have to take a new medicine for this study?
No, you will only take filgotinib if your doctor has already prescribed it for your rheumatoid arthritis as part of your normal treatment.
What kind of electronic device do I need?
You'll need a smartphone or tablet to answer questions about your health and how you're feeling during the study.
Will my information be kept private?
Yes, all your personal and health information collected during the study will be kept confidential and handled securely.
Can I stop participating in the study at any time?
Yes, you are free to withdraw from the study at any point without it affecting your medical care or relationship with your doctor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.