AuthorisedTherapeutic use (Phase IV)Interventional

Non-inferiority study of TOCILIZUMAB in dose-banding versus dose-weight in rheumatoid arthritis with low activity or clinical remission

This research is investigating a common medicine called RoActemra (tocilizumab), used to treat rheumatoid arthritis. The study aims to see if a new way of giving this medicine, called 'dose-banding', is just as good as the current method, which is based on a person's weight. Dose-banding means taking a standard dose of the medicine, which could make it simpler to prepare and administer. We are focusing on patients whose rheumatoid arthritis is already well-controlled, meaning they have low disease activity or are in remission. The main goal is to compare how well both methods keep the arthritis under control over a three-month period. We also want to understand if this new dosing method could be more cost-effective for the NHS.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire De Nice

Enrolment target

122

Start

24 Mar 2026

rheumatoid arthritis

What is this study about?

This clinical trial is designed to investigate a new way of giving a medicine called RoActemra (tocilizumab), which is commonly used to treat rheumatoid arthritis. Rheumatoid arthritis is a condition where the body's immune system mistakenly attacks its own joints, causing pain, swelling, and stiffness. RoActemra works by calming down this overactive immune system.

Currently, the dose of RoActemra a person receives is often calculated based on their body weight. This study is exploring a different approach called 'dose-banding'. With dose-banding, doctors give a standard dose within certain weight ranges, rather than a precise dose for every individual weight. The main reason for looking into this is that it might make preparing and giving the medicine simpler and potentially more efficient.

The most important question this study wants to answer is whether dose-banding works just as well as the current weight-based dosing. We want to make sure that patients still get the same good results in managing their rheumatoid arthritis, especially those who already have their condition mostly under control (meaning low disease activity or in remission). The study will look closely at how well the arthritis is controlled over a three-month period using both methods. It also aims to see if dose-banding could help save money in the long run for the NHS due to simpler preparation.

Key takeaways

This study compares two ways of giving RoActemra for rheumatoid arthritis.
It aims to see if 'dose-banding' works as well as weight-based dosing.
Only people with well-controlled rheumatoid arthritis can join.
The study lasts for three months and involves regular hospital visits.
Results could make RoActemra treatment simpler and more efficient.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To take part in this study, you generally need to be an adult, aged 18 or older. Both men and women can participate. The study is specifically looking for people who have rheumatoid arthritis.

Crucially, your rheumatoid arthritis needs to be well-managed. This means your condition should either have 'low disease activity' or be in 'clinical remission'. Low disease activity means your symptoms are pretty mild and controlled, while remission means your symptoms are largely gone or very minimal.

More specific details about your current health and other medicines you might be taking would be discussed by the study team to make sure it's safe and appropriate for you to join.

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?
Is your rheumatoid arthritis currently well-controlled (low activity or in remission)?
Are you receiving or suitable to receive RoActemra (tocilizumab)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive RoActemra infusions. The study will compare two different ways of dosing the medicine: one based on your weight (the current method) and one using a standard dose within a certain range (dose-banding). You would be randomly assigned to one of these groups.

The main part of the study will last for three months. During this time, you'll have regular hospital visits for your infusions and assessments. These assessments will involve checks by the medical team and may include blood tests and questionnaires to track how your rheumatoid arthritis is responding to the treatment. They will specifically look at your disease activity score (called DAS28) at the start and after three months.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as contributing to new knowledge that might improve how treatments are given for rheumatoid arthritis in the future, potentially making them more efficient. You would also receive close medical attention during the study period. However, as with any medical treatment, there are potential risks associated with RoActemra, and the study involves receiving the medication in a potentially different way. These risks would be fully explained to you by the study team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without 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 body's immune system attacks your joints, causing pain, swelling, and stiffness.

What is RoActemra (tocilizumab)?

RoActemra is a medicine used to treat rheumatoid arthritis by calming down the overactive immune system that attacks the joints.

What does 'dose-banding' mean?

Dose-banding means doctors give a standard dose of medicine within certain weight groups, rather than calculating a unique dose for every single person's weight.

Why is this study important?

This study aims to find out if a simpler way of giving RoActemra, called dose-banding, works just as well as the current method, and if it could be more efficient and cost-effective.

How long will I be in the study?

The main part of the study involves receiving treatment and being monitored over a period of three months.