Active not recruitingPHASE3INTERVENTIONAL

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

This study is a long-term look at a medicine called ocrelizumab for people with Multiple Sclerosis (MS). It's for patients who have already been receiving ocrelizumab in a previous Roche study. The main goal is to find out how safe and effective ocrelizumab is when used for a longer period. People taking part will continue to receive the same dose of ocrelizumab they were on in their earlier study, or be monitored if they had stopped treatment. This type of study helps doctors understand the long-term effects of treatments, which is very important for conditions like MS that require ongoing care. It’s about ensuring the medicine continues to work well and remains safe over time.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

1,300

Start

03 May 2022

Estimated completion

31 Dec 2027

Multiple Sclerosis

What is this study about?

This research study is designed to follow people with Multiple Sclerosis (MS) who have already been taking a medicine called ocrelizumab in a previous study. Think of it like a 'continuation' chapter to an existing story. The main aim is to understand how well ocrelizumab works and how safe it is over a longer period of time.

Doctors and researchers want to see if the benefits of ocrelizumab continue, and if any long-term side effects appear. This is really important because MS is a long-lasting condition, and treatments often need to be taken for many years. By extending the follow-up, this study helps gather valuable information that can improve care for people with MS in the future.

If you're already receiving ocrelizumab in certain previous studies, or were being monitored after stopping it, you might be invited to join this extension study. You would continue to receive the same dose of ocrelizumab you were getting before, or continue to be monitored for your safety. This means you wouldn't be starting a new treatment, but rather continuing or extending your involvement in the research.

Key takeaways

This study is for people already in specific MS treatment studies with ocrelizumab.
It aims to understand the long-term safety and effectiveness of ocrelizumab.
Participants will continue receiving their current ocrelizumab treatment or safety monitoring.
It helps gather vital information for future MS care.
Your participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, you must have previously taken part in one of three specific Roche studies involving ocrelizumab (WA21092, WA21093, or WA25046). In that previous study, you must have either been receiving ocrelizumab or have completed treatment and were in the safety monitoring phase.

For women who could become pregnant, you need to agree to either avoid sex or use effective contraception (birth control) throughout the study and for at least 6 months after your last dose of ocrelizumab. This is to ensure your safety and the safety of any potential pregnancy.

You cannot join this study if you are currently taking part in any other clinical trial, apart from the specific parent study this trial is extending. You also need to be willing and able to follow all the study's rules and procedures.

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.

Have I previously taken part in Roche study WA21092, WA21093, or WA25046?
Was I receiving ocrelizumab or in safety follow-up in one of those studies?
Am I willing to use acceptable birth control (if I am a woman who could become pregnant)?
Am I currently not taking part in any other clinical study (except my previous ocrelizumab study)?
Am I able and willing to follow all the study instructions?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive ocrelizumab if you were already on it, at the same dose you were taking before. If you had stopped treatment and were being monitored, you would continue to be monitored. The study team will explain the specific schedule of visits, which will likely involve regular check-ups, examinations, and possibly blood tests to monitor your health and how the medicine is working. These visits might be similar to what you experienced in your previous study. The total duration of your participation will depend on how long the study runs, and you will be kept informed about this.

Potential risks and benefits

The potential benefit of taking part is that you would continue to receive ocrelizumab, which may help manage your MS, or you would continue to be safely monitored if you had stopped treatment. This further participation also contributes to valuable long-term understanding of ocrelizumab for MS patients. Potential risks are generally those associated with ocrelizumab itself, which you should already be familiar with from your previous study, and the usual minor discomforts of study visits like blood draws. You will be closely monitored for any health changes. Remember, joining this study is entirely your choice, and you are free to leave at any time without giving a reason, and it won't affect your medical care.

Locations (235)

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

Barrow Neurological Institute
Verified postcode
Phoenix, United States
Arizona Neuroscience Research LLC
Verified postcode
Phoenix, United States
MS Center of California
Verified postcode
Laguna Hills, United States
Stanford Hospital and Clinics
Verified postcode
Palo Alto, United States
University of California San Francisco
Verified postcode
San Francisco, United States
University of California San Francisco
Verified postcode
San Francisco, United States
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Verified postcode
Aurora, United States
Advanced Neurosciences Research LLC
Verified postcode
Fort Collins, United States
Neurology Associates PA
Verified postcode
Maitland, United States
University of Miami
Verified postcode
Miami, United States
Neurological Services of Orlando
Verified postcode
Orlando, United States
University of South Florida
Verified postcode
Tampa, United States

Common questions

What is ocrelizumab?

Ocrelizumab is a medicine used to treat Multiple Sclerosis (MS).

Who can join this study?

You can join if you've already been part of a specific ocrelizumab study (WA21092, WA21093, or WA25046) and were either taking the medicine or being monitored for safety.

What will I have to do in this study?

You'll continue your ocrelizumab treatment or safety monitoring, and attend regular check-ups and tests as part of the study.

Will I get paid to join?

The study information provided doesn't mention payment for participation, but you can ask the study team.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your future medical care.