Ongoing, recruitingTherapeutic use (Phase IV)Interventional

ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TARGETED TREATMENT INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPENLABELED, SUPERIORITY TRIAL. -SUNSTAR-

This research study, called SUNSTAR, is for adults living with rheumatoid arthritis who haven't found enough relief from one or two other targeted treatments. We are comparing two medicines, Orencia (abatacept) and RoActemra (tocilizumab), which are both given as injections. The main goal is to see which medicine is better at reducing the signs and symptoms of rheumatoid arthritis after six months. We'll be looking at things like how many joints are tender or swollen, and how patients feel overall. We also want to understand more about how these medicines work and any side effects they might cause over 12 months.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Groupement Des Hopitaux De L'Institut Catholique De Lille

Enrolment target

224

Start

31 Jul 2024

Adults patients suffering from rheumatoid arthritis and in adequate response to one or two targeted treatments.

What is this study about?

You might have heard of this research study called SUNSTAR. It's looking into two medicines, Orencia and RoActemra, that are used to treat rheumatoid arthritis. These medicines are given by injection, and they typically help to calm down the overactive immune system that causes the condition. The study is specifically designed for people who have already tried one or two other modern treatments for their rheumatoid arthritis, often called 'targeted treatments', but haven't found them effective enough to control their symptoms.

The main aim of this study is to compare how well Orencia and RoActemra work. Doctors will be checking to see which medicine helps to reduce the symptoms of rheumatoid arthritis, such as joint pain and swelling, more effectively over a period of six months. They'll use a special score, called the Clinical Disease Activity Index (CDAI), which looks at how many joints are tender or swollen, and how you and your doctor feel your disease is doing overall. This helps them get a clear picture of how much your rheumatoid arthritis is improving.

Beyond the first six months, the study will continue to follow people for a full year. This allows researchers to see how well the treatments continue to work over time, explore other ways the treatments might help (like improving quality of life), and carefully record any side effects. By doing this, the study hopes to provide valuable information to doctors and patients about the best ways to manage rheumatoid arthritis when initial treatments haven't been fully successful.

Key takeaways

The study compares two licensed medicines for rheumatoid arthritis: Orencia and RoActemra.
It's for adults whose current treatments for rheumatoid arthritis aren't working well enough.
The main goal is to see which medicine best reduces rheumatoid arthritis symptoms over 6 months.
Participation involves regular clinic visits, injections, and health checks over a year.
It helps doctors understand more about these treatments and their effects.
You can stop participating at any time.

Who may be eligible?

This study is looking for adult volunteers, aged 18 or over. This means anyone from 18 years old upwards can be considered.

To be eligible, you must have been diagnosed with rheumatoid arthritis. Importantly, your rheumatoid arthritis should not be well-controlled by the one or two targeted treatments you might have tried already. This study is specifically for people where their current or previous treatments haven't been effective enough.

Both men and women can take part in this research. There will be other specific medical checks to make sure the study is a good fit for your health situation, so it's important to discuss this with your doctor.

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 rheumatoid arthritis?
Has your rheumatoid arthritis not improved enough with other modern treatments?
Are you happy to have regular injections and clinic visits for 12 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either Orencia or RoActemra, both given as an injection using a pre-filled syringe. You'll have regular appointments over 12 months where doctors will assess your rheumatoid arthritis. During these visits, the medical team will check your joints for tenderness and swelling, ask you questions about how you feel, and likely complete questionnaires about your quality of life. They will also take blood samples to monitor your overall health and how the treatment is affecting you. There will also be some imaging tests, like ultrasounds of your joints and X-rays of your hands, wrists, and feet, at certain points. The total duration of active participation in the study will be 12 months.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving close medical attention and access to a supervised treatment that could improve your rheumatoid arthritis symptoms. However, like all medicines, Orencia and RoActemra can have side effects, which the study will carefully monitor. You might experience common side effects, or in some cases, more serious ones. 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
France

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term condition where your immune system mistakenly attacks healthy cells in your joints, leading to pain, swelling, and stiffness.

What does 'targeted treatment' mean?

Targeted treatments are medicines designed to home in on specific parts of the immune system that cause inflammation in rheumatoid arthritis, often working differently from older medications.

What is a 'pre-filled syringe'?

A pre-filled syringe is a ready-to-use injection device that contains a single dose of medicine, making it easier and safer to administer.

Will I know which medicine I'm getting?

This is an 'open-label' study, which means both you and your doctor will know whether you are receiving Orencia or RoActemra.

What happens if the medicine doesn't work for me?

The study will closely monitor your condition, and if the treatment isn't controlling your rheumatoid arthritis well enough, your doctor will discuss other options with you.