Active not recruitingPHASE3INTERVENTIONAL

LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB

This study follows people with multiple sclerosis (MS) who have previously taken ocrelizumab, a treatment that can help manage the condition. The main goal is to understand the long-term effectiveness and safety of ocrelizumab, particularly in slowing down the progression of disability. Researchers want to see if the medicine can help people avoid needing walking aids or wheelchairs, and whether it protects arm and hand function, which is really important for everyday life. People who finished a previous 4-year study called CONSONANCE and whose doctors think they would benefit from continuing ocrelizumab may be invited to join this 4-year follow-up study.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

Start

08 Mar 2022

Estimated completion

24 Feb 2029

Multiple Sclerosis

What is this study about?

This study is designed to learn more about a medicine called ocrelizumab for people living with multiple sclerosis (MS). We already know a bit about how this medicine works from earlier studies, but what we don't fully understand is its long-term impact. MS can unfortunately lead to increasing disability over time, affecting movement and other important daily activities. This study aims to track participants over several years to see if ocrelizumab can help slow down or even prevent some of these changes, like needing walking aids or a wheelchair.

One key area this research focuses on is how long ocrelizumab might delay significant disability milestones. For example, some people with MS eventually need to use a walking stick, a frame, or a wheelchair. Reaching these points can greatly affect a person's quality of life. The study will look closely at this to see if the medicine helps people stay independent for longer. It will also examine how ocrelizumab affects the use of arms and hands, which is vital for tasks like eating, dressing, and writing.

By following people for an extended period, this study hopes to provide valuable information about how ocrelizumab can help manage MS over many years. This understanding is very important because it can give patients and their doctors a clearer picture of the long-term benefits and safety of this treatment, helping them make informed decisions about managing their MS.

Key takeaways

It's a follow-up study for people who previously used ocrelizumab for MS.
The main goal is to see how ocrelizumab works long-term on disability and daily activities.
It specifically looks at delaying the need for walking aids/wheelchairs and protecting arm/hand function.
The study lasts about 4 years, with regular medicine infusions and check-ups.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you must have previously participated in and completed a specific 4-year study called CONSONANCE, where you received ocrelizumab treatment. Your neurologist must also believe that continuing treatment with ocrelizumab would be good for your health.

You should be able to understand and sign a consent form, show that you can follow the study's instructions, and be part of the social security system in the UK.

If you are a woman who could become pregnant, you'll need to have negative pregnancy tests at key points and agree to use reliable birth control methods throughout the study and for at least 6 months after your last dose of ocrelizumab. If you happened to get pregnant between the CONSONANCE study and this one, you can still join, but your ocrelizumab treatment would be paused until after you've given birth or stopped breastfeeding.

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.

Did you complete the previous CONSONANCE study with ocrelizumab?
Does your neurologist think continuing ocrelizumab would be good for you?
Are you able to follow study instructions and attend regular appointments?
If you could become pregnant, are you willing to use reliable birth control during the study and for 6 months after?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for about 4 years. During this time, you will continue to receive ocrelizumab infusions every 24 weeks (roughly every 6 months). There will be regular visits to the clinic for these infusions and check-ups.

Before you start, there's a 'screening' visit, usually up to two weeks after your last visit in the CONSONANCE study. This is to ensure you meet all the requirements. Your first ocrelizumab infusion in this study will happen about 24 weeks after your last infusion in the CONSONANCE study.

Throughout the 4 years, you will have infusions and check-ups approximately every 24 weeks. The very last visit will be 24 weeks after your final dose of ocrelizumab. At these visits, doctors will monitor your MS and check how you are doing.

Potential risks and benefits

Taking part in this study could offer the benefit of continuing a treatment that your doctor believes is helping manage your MS, potentially delaying the progression of disability and maintaining your ability to carry out daily tasks. As with any medication, there can be potential risks or side effects from ocrelizumab, which your doctor will discuss with you. You will be closely monitored for any issues throughout the study. Remember, joining any clinical study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Amiens University Hospital
Verified postcode
Amiens, France
Bayonne Hospital
Verified postcode
Bayonne, France
Bordeaux University Hospital
Verified postcode
Bordeaux, France
Caen University Hospital
Verified postcode
Caen, France
Clermont ferrand University Hospital
Verified postcode
Clermont-Ferrand, France
Lille University Hospital
Verified postcode
Lille, France
Lyon University Hospital
Verified postcode
Lyon, France
Marseille Univesity Hospital
Verified postcode
Marseille, France
Montpellier University Hospital
Verified postcode
Montpellier, France
Nancy University Hospital
Verified postcode
Nancy, France
Nantes University hospital
Verified postcode
Nantes, France
Nice University Hospital
Verified postcode
Nice, France

Common questions

What is ocrelizumab?

Ocrelizumab is a medicine used to treat multiple sclerosis (MS) that targets specific immune cells.

How long will this study last?

This study is planned to last for about 4 years.

Why is this study looking at arm and hand function?

Maintaining good arm and hand function is very important for everyday tasks and overall independence for people with MS.

What happens if I get pregnant during the study?

If you are a woman who becomes pregnant, your ocrelizumab treatment will be paused until after you've given birth or stopped breastfeeding.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and your decision will not affect your medical care.