AuthorisedTherapeutic use (Phase IV)Interventional

Filgotinib bridging in newly diagnosed rheumatoid arthritis patients (FAST RA trial); A pragmatic randomized controlled non-inferiority low intervention clinical trial

The FAST RA trial is looking at how well and how quickly two different treatments help people who have just been diagnosed with rheumatoid arthritis. Researchers want to find out if Kenacort-A, a steroid injection, or Jyseleca, a tablet, is better at putting the condition into remission (meaning symptoms are much less noticeable) after three months. The study will also keep track of things like how well people feel over a year, any side effects, and how easy the treatments are to stick to. Ultimately, the goal is to improve how new rheumatoid arthritis is treated to help patients feel better sooner and for longer.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Medisch Spectrum Twente

Enrolment target

168

Start

16 Jan 2025

Rheumatoid arthritis

What is this study about?

This research, called the FAST RA trial, is for people who have recently been diagnosed with rheumatoid arthritis. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. The main aim of this study is to compare two different ways of treating new rheumatoid arthritis to see which one helps people feel much better, or 'in remission', quicker.

One of the treatments being looked at is Kenacort-A, which is a steroid injection. Steroids are medicines that can help reduce swelling and pain. The other treatment is Jyseleca, which is a newer tablet that works by calming down the overactive immune system that causes rheumatoid arthritis. The study wants to find out what percentage of people on each treatment are in remission after just three months. This is important because getting the condition under control early can lead to better long-term outcomes.

The research will also look at other important things over a whole year. This includes checking how people's symptoms change over time, any side effects they might experience, how satisfied they are with their treatment, and how much the condition impacts their daily life. By gathering all this information, doctors can learn more about the best ways to treat new rheumatoid arthritis, helping future patients get the most effective and comfortable care possible.

Key takeaways

This study is for adults newly diagnosed with rheumatoid arthritis.
It compares two treatments: a steroid injection (Kenacort-A) and a tablet (Jyseleca).
The main aim is to find out which treatment helps people achieve remission faster.
Participation involves regular check-ups and lasts for about one year.
You will be closely monitored for any side effects or changes in your condition.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 years and older who have recently been diagnosed with rheumatoid arthritis. It doesn't matter if you are male or female; anyone meeting the age and diagnosis criteria can be considered.

The researchers are specifically interested in people who are new to their rheumatoid arthritis diagnosis, meaning they haven't been on these types of treatments for the condition for a long time already. This helps them understand how effective the treatments are right from the start.

Further specific requirements will be discussed with your doctor to make sure the study is a safe and suitable option 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.

Are you 18 years old or older?
Have you recently been diagnosed with rheumatoid arthritis?
Are you able to attend regular clinic appointments for about a year?
Are you willing to try one of the two study treatments?
Do you understand that you might not know which treatment you are receiving?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the Kenacort-A injection or Jyseleca tablets. You would have regular check-ups with the study team, likely including clinic visits where they would ask about your symptoms, do examinations, and take blood tests to see how your condition is responding to the treatment and to check for any side effects. You might also fill out questionnaires about how you are feeling and your quality of life.

These visits would happen at different times over a year – for example, at three, six, nine, and twelve months after starting the treatment. The total duration of your active participation in receiving treatment and being monitored for the study would be for about one year. After this, there might be some longer-term follow-up to see how you are doing.

Potential risks and benefits

Taking part in this study might offer the potential benefit of closer monitoring of your rheumatoid arthritis and access to different treatments, which could help you achieve remission faster. However, like all medications, the treatments being studied can have side effects, which the research team will closely monitor. There's also no guarantee that either treatment will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a condition where your body's immune system mistakenly attacks your own joints, causing pain, swelling, and stiffness.

What does 'remission' mean in this study?

In this study, 'remission' means that your rheumatoid arthritis symptoms are very low and your doctor sees little to no sign of active disease in your joints.

What are the treatments being tested?

The study is comparing a steroid injection called Kenacort-A with a tablet called Jyseleca, both used to treat rheumatoid arthritis.

How long will I be in the study?

You would be actively involved in the study, receiving treatment and having check-ups, for about one year.

Will I know which treatment I'm getting?

This is a 'randomised' trial, meaning you will be randomly assigned to one of the treatments. Sometimes, in these types of studies, neither you nor your doctor will know which treatment you are receiving until the study is over, to make the results as fair as possible.