Not yet recruitingPHASE4INTERVENTIONAL

Tdose Binding and Tocilizumab

This research is testing two ways of giving a medicine called tocilizumab to people with rheumatoid arthritis. Tocilizumab is used when other treatments haven't worked well enough. Currently, the dose of tocilizumab is usually based on a person's weight. This study is comparing that to a standard, fixed dose for everyone. The aim is to find out if giving a standard dose is just as effective for patients whose arthritis is already in remission (no symptoms) or has low activity. This could make it simpler to prepare and give the medicine. Participants will receive tocilizumab, either with a standard dose or a weight-based dose, and doctors will monitor their arthritis over three months.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

122

Start

01 Jun 2026

Estimated completion

31 Dec 2026

Rheumatoid Arthritis

What is this study about?

This study is looking into whether there's a simpler and equally effective way to give a medicine called tocilizumab to people with rheumatoid arthritis. Rheumatoid arthritis is a condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness. Tocilizumab is a common treatment for many people when other medicines haven't helped enough.

Currently, the amount of tocilizumab given to a patient usually depends on their body weight. This study is comparing this ‘weight-based’ dosing to a ‘fixed’ dose, which means everyone gets the same amount of the medicine. The main goal is to see if this fixed dose works just as well as the weight-based dose for people whose rheumatoid arthritis is already stable – meaning their symptoms are minimal or they are in remission.

Finding out if a fixed dose is just as good could make things easier. For example, it might simplify how the medicine is prepared in the pharmacy and potentially reduce costs. The study will also look at how quickly the medicine can be prepared and given out to patients, and whether less medicine goes to waste. Patients will be monitored closely for three months to see how their arthritis responds to the different dosing methods.

Key takeaways

Compares two ways of giving tocilizumab for rheumatoid arthritis.
Aims to see if a standard dose is as good as a weight-based dose.
For people whose arthritis is already well-controlled or in remission.
Could make tocilizumab treatment simpler and potentially more efficient.
You won't know which dose you're receiving to ensure fair results.

Who may be eligible?

To join this study, you need to have been diagnosed with rheumatoid arthritis using specific medical guidelines. Your rheumatoid arthritis also needs to be well-controlled, meaning you have very few symptoms or none at all (this is called remission or low activity). You must also be currently receiving tocilizumab at a specific dose (8mg per kg of body weight) because other arthritis treatments didn't work for you. You can still be taking other common arthritis medicines like certain tablets, pain relievers, or low-dose steroids, as long as you've been on a steady dose for at least three months.

You cannot join if you have active cancer, or if you are taking tocilizumab for a different condition or at a different dose than specified. You also can't take part if you have diverticulitis (an inflammatory bowel condition) or if you've had a digestive perforation (a hole in your digestive tract) in the past.

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.

Do you have a confirmed diagnosis of rheumatoid arthritis?
Is your rheumatoid arthritis currently in remission or have low activity?
Are you currently receiving tocilizumab infusions at 8mg/kg because other treatments didn't work?
Are you able to continue with your current stable arthritis medications?
Do you have a history of diverticulitis or digestive perforation?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will continue to receive your tocilizumab infusions as usual. The main difference will be that you will be randomly assigned to receive either the standard dose of tocilizumab or a dose based on your weight. Neither you nor the doctor checking your progress will know which dose you are receiving, to keep the results fair. The study will last for at least three months, during which your doctors will monitor your rheumatoid arthritis closely to see how you are responding to the treatment.

Potential risks and benefits

Potential benefits of taking part could include helping to find a simpler way to give tocilizumab, which might improve how this treatment is managed for future patients. As with any medical study, there are potential risks, though receiving an established medication like tocilizumab means many side effects are already known. You will be closely monitored by your medical team throughout the study. Remember, you can always change your mind and withdraw from the study at any time without it affecting your usual medical care.

Locations (1)

CHU de Nice
Verified postcode
Nice, France

Common questions

What is tocilizumab?

Tocilizumab is a medicine used to treat rheumatoid arthritis when other treatments haven't worked well. It helps to reduce inflammation in your joints.

What is 'remission' or 'low activity' in rheumatoid arthritis?

This means your rheumatoid arthritis symptoms are either completely gone or are very mild and well-controlled, thanks to your current treatment.

Will I know if I'm getting the standard or weight-based dose?

No, neither you nor your doctor will know which type of dose you are receiving. This is to ensure the study results are fair and unbiased.

Why are they doing this study?

The study aims to see if a simpler, standard dose of tocilizumab works just as well as the current weight-based dose, which could make the treatment easier to manage and less costly to prepare.

How long will I be in the study?

You will be followed for at least three months after starting the new dosing method.

How to find out more

Christian ROUX, Professor

roux.c2@chu-nice.fr 0492035477 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.