Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

This research is investigating a potential new medicine, Ocrelizumab (also known as Ocrevus®), for adults living with primary progressive multiple sclerosis (PPMS). The study aims to find out if Ocrelizumab is safe and if it can help improve symptoms or slow down the disease compared to a dummy medicine (placebo). This includes people who have been living with PPMS for a longer time. Participants will be carefully monitored over several years, with some receiving the study drug and others a placebo, to understand its effects. There are different stages in the study, including an initial screening, a main treatment period, and long-term follow-up to see how people do over time. The goal is to gather important information that could help people with PPMS in the future.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

1,013

Start

12 Aug 2019

Estimated completion

19 Jan 2028

Multiple Sclerosis, Primary Progressive

Results

Results from this study

Posted February 2026

Results have been published for this study.

Primary outcome

Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS

Time to onset of cCDP12=time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-hole Peg Test (9-HPT) confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in Expanded Disability Status Scale (EDSS) score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems \& ambulation, that ranges in 0.5-point steps from 0 \[normal\] to 10.0 \[death\]. 9-HPT is a quantitative measure of arm \& hand function, where participants placed \& removed pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.

Full results on the registry

What is this study about?

This study is happening because researchers want to find new and better ways to help people with primary progressive multiple sclerosis (PPMS). PPMS is a type of MS where symptoms gradually get worse over time from the beginning, without periods of recovery. Currently, there aren't many treatments for PPMS, so finding new options is very important.

The medicine being tested is called Ocrelizumab (you might hear it called Ocrevus®). It's a type of drug that works on the immune system, which is what sometimes mistakenly attacks the body in MS. The study wants to see if Ocrelizumab can help slow down the progression of PPMS and if it's safe for people to use.

To do this, some people in the study will get Ocrelizumab, and others will get a 'placebo', which looks exactly like the real medicine but contains no active drug. This helps the researchers understand if any changes are due to Ocrelizumab itself, or if they happen for other reasons. The study includes adults aged 18 to 65 and is designed to run for several years to get a clear picture of how the treatment works over time.

Key takeaways

This study is testing a new drug for primary progressive MS.
It aims to see if Ocrelizumab is safe and effective in slowing the disease.
Some participants will receive the active drug, others a dummy drug (placebo).
Participation involves regular clinic visits and medication infusions over several years.
Your health will be closely monitored throughout the study.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 65 years old and have primary progressive multiple sclerosis (PPMS). Your MS symptoms should have been stable for at least a month before starting the study. We'll also check your overall health to make sure it's safe for you to take part.

There are also specific requirements based on how much your MS affects your balance, walking, and hand movements. For example, your MS symptoms, particularly how they affect your movement, will need to be within a certain range as measured by specific tests. Also, tests on your spinal fluid might be checked for certain markers related to MS.

You cannot join the study if you have another type of MS, like relapsing-remitting or secondary progressive MS. You also can't take part if you have a serious ongoing infection, like tuberculosis. If you've recently used other immune-system affecting medicines, you might need to wait a while before joining, and women who could become pregnant must agree to use effective contraception during and after the study.

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 between 18 and 65 years old?
Do you have primary progressive multiple sclerosis (PPMS)?
Have your MS symptoms been stable for at least the last month?
Do you not have any serious ongoing infections like tuberculosis?
If you are a woman who could become pregnant, are you willing to use effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your journey will be divided into several stages. First, there's a screening period of up to about 5 and a half months to make sure the study is right for you. If you qualify, you'll enter the main treatment phase, which will last at least 144 weeks (about 2 years and 9 months). During this time, you'll receive either Ocrelizumab or a placebo (a dummy drug) as an infusion every 24 weeks (roughly every 6 months).

Throughout the study, you'll have regular visits to the clinic for check-ups, assessments, and to receive your study medication. These visits will involve various tests, including neurological exams, to see how your MS is changing. Following the main treatment, there will be follow-up periods, potentially including an optional 'open-label' phase where everyone might get Ocrelizumab if their doctor thinks it would be beneficial, even if they were on placebo initially. The full duration of your involvement, including follow-up, could be several years.

Potential risks and benefits

Taking part in a study like this might have potential benefits, like access to a new treatment that isn't widely available yet, and contributing to medical knowledge that could help others with PPMS. However, there are also potential risks; Ocrelizumab, like any medication, can have side effects. You might experience infusion-related reactions or have a higher risk of certain infections. You will be closely monitored for any problems. It's very important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (155)

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

Georgetown University Medical Center
Verified postcode
Washington D.C., United States
MS and Neuromuscular Center of Excellence
Verified postcode
Clearwater, United States
Neurological Services of Orlando
Verified postcode
Orlando, United States
Vero Neurology
Verified postcode
Vero Beach, United States
University of Kansas Medical Center
Verified postcode
Kansas City, United States
The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company
Verified postcode
Columbus, United States
Columbus Neuroscience
Verified postcode
Westerville, United States
Albert Einstein Medical Center
Verified postcode
Philadelphia, United States
Brain and Mind Research Institute
Verified postcode
Camperdown, Australia
Austin Hospital
Verified postcode
Heidelberg, Australia
Royal Melbourne Hospital
Verified postcode
Parkville, Australia
UZ Antwerpen
Verified postcode
Edegem, Belgium

Common questions

What is Primary Progressive Multiple Sclerosis (PPMS)?

PPMS is a type of Multiple Sclerosis where symptoms gradually worsen over time from the beginning, rather than coming and going.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active drug. It helps researchers understand if the real medicine is actually working.

How often will I need to visit the clinic?

During the main treatment phase, you'll likely visit the clinic every 24 weeks (about every 6 months) for your study medication and check-ups.

Can I stop participating in the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, without affecting your regular medical care.

What is Ocrelizumab?

Ocrelizumab, also known as Ocrevus®, is a medicine that targets certain immune cells involved in MS, with the aim of reducing disease activity.