AuthorisedTherapeutic exploratory (Phase II)Interventional

An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Rheumatoid Arthritis who Participated in Previous Afimkibart Clinical Trials

If you have moderate to severe rheumatoid arthritis and have previously participated in a clinical trial for the new medicine afimkibart (also known as RO7790121), this study might be for you. It's an extension of those earlier studies, designed to gather more information about the long-term effects of this treatment. Researchers want to understand its safety over a longer time, including any side effects that might occur. They also want to see how well afimkibart continues to help improve symptoms of rheumatoid arthritis, such as joint pain and swelling. The aim is to build a clearer picture of this medicine's benefits and potential drawbacks when used over a longer period.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

27 May 2026

moderate to severe rheumatoid arthritis (RA)

What is this study about?

This research study is an extension of previous trials looking into a new medication called afimkibart (you might also see it referred to as RO7790121). It's specifically for people who have been diagnosed with moderate to severe rheumatoid arthritis and have already taken part in an earlier study involving this drug. The main purpose of this extension study is to understand the long-term safety and how well afimkibart works over a longer period.

Researchers will be carefully watching for any side effects, both common and serious, to get a full picture of what to expect from this medication. They will also be tracking how well it helps manage rheumatoid arthritis symptoms, such as reducing joint pain, swelling, and stiffness. This ongoing monitoring will help them understand if the drug continues to be effective and if there are any new or ongoing safety concerns.

By taking part, you would be helping medical science learn more about afimkibart. This kind of research is really important for developing new and better treatments for conditions like rheumatoid arthritis, giving people more options in the future.

Key takeaways

This study is for people with moderate to severe rheumatoid arthritis.
You must have already participated in an earlier afimkibart drug trial.
It aims to understand the long-term safety and effectiveness of afimkibart.
Researchers will monitor side effects and how well the drug controls your arthritis.
Participation involves regular clinic visits and health checks.

Who may be eligible?

To be considered for this study, you must have already taken part in a previous clinical trial for the drug afimkibart. This means you would have already received this specific treatment as part of that earlier research.

Participants must be 18 years old or older. The study is open to both men and women. Generally, other health conditions or medications might be discussed with the study doctor to make sure it's safe for you to take part.

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 moderate to severe rheumatoid arthritis?
Have you already taken part in a previous clinical study for afimkibart (RO7790121)?
Are you able to attend regular clinic visits for check-ups and tests?
Are you open to continuing treatment with afimkibart?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would continue to receive the study medication, afimkibart, as prescribed by the research team. This study is an extension, so many of the procedures might be familiar from your previous trial. Researchers will regularly check your health to monitor for any side effects and see how your rheumatoid arthritis is responding to the treatment. This will involve regular clinic visits where you might have physical exams, blood tests, and answer questions about how you are feeling and how your arthritis symptoms are. The total duration of your participation would depend on the study plan, which the research team would explain to you in detail.

Potential risks and benefits

Potential benefits of participating could include continued access to a new treatment for your rheumatoid arthritis and close medical monitoring of your condition. However, there's no guarantee that afimkibart will improve your symptoms, or that it won't cause side effects. Possible risks are those associated with the study drug, which would have been discussed in your original trial, and the minor discomforts of occasional blood tests and clinic visits. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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

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Unverified
Italy
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Unverified
Spain
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Unverified
Germany
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Unverified
France
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Unverified
Denmark
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Unverified
Poland
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Unverified
Belgium

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness, mainly in the hands, feet, and wrists.

What is afimkibart?

Afimkibart (also known as RO7790121) is a new medicine being studied to see if it can help treat rheumatoid arthritis.

Why is this an 'extension study'?

An extension study means it's a continuation of earlier research. It allows doctors to gather more information about a treatment's safety and effectiveness over a longer period.

Will I get the actual drug or a dummy pill?

Since this is an extension study for people who have already been in an afimkibart trial, you would generally continue to receive the active study medicine, afimkibart.

What if I experience side effects?

The study team will monitor you closely for any side effects. It's important to report anything unusual to them immediately so they can provide appropriate care and advice.