Phase 3 Multiple Sclerosis Trial, Terminated NCT03085810 Sponsor: Hoffmann-La Roche Condition: Multiple Sclerosis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03085810) involved a single treatment group receiving ocrelizumab, a medicine used in multiple sclerosis. A total of 1,225 people began the main part of the study, of whom 1,010 completed it. A separate sub-study ran alongside the main study, looking at two different ways of giving the infusion (a conventional infusion and a shorter infusion), with 373 people in each of those two groups. The trial was mainly tracking changes in participants' disability levels over time, using a standard scale called the EDSS (which runs from 0, meaning no disability, to 10). Specifically, it measured how many people experienced worsening disability that lasted at least 24 or 48 weeks, and how many showed confirmed improvement in their disability score. The reported data shows that, during Year 1, between approximately 97% and 99.6% of participants did not experience confirmed disability worsening lasting 24 or 48 weeks, depending on the specific time point measured. For disability improvement (defined as a meaningful reduction on the EDSS score sustained over time), the reported figures ranged from around 83.5% to 95.1% at Year 1, and from approximately 90% to 100% at Years 2 and 4, again varying by the specific time point and threshold used. For the primary outcome measuring the overall time until disability worsening first occurred, the reported data shows the value was listed as "not available," meaning that particular result was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Multiple Sclerosis Trial, Terminated

NCT03085810
Terminated Phase 3 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You have been officially diagnosed with relapsing-remitting multiple sclerosis (RRMS) using a specific standard diagnostic method called the McDonald 2010 criteria
  • Your MS was first diagnosed or first showed clear symptoms no more than 3 years ago
  • In the past 12 months, you have had at least one MS relapse (flare-up) or at least one sign of MS activity shown on an MRI scan
  • Your level of physical disability, measured by a standard MS scale, falls within a mild range at the time of screening (confirm with trial site)
  • If you are a woman who could become pregnant, you agree to use an acceptable form of birth control during the study and for at least 6 months after your last dose of the study drug

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You have a form of MS that is progressively worsening, such as secondary progressive, primary progressive, or progressive relapsing MS
  • You are unable to have an MRI scan for any reason
  • You have another known neurological condition affecting your brain or nervous system
  • You are currently pregnant or breastfeeding
  • You are planning to become pregnant during the study or within 6 months of your last dose of the study drug
  • You have another illness that requires long-term use of steroid medications or immune-suppressing drugs
  • You have a current or past condition where your immune system does not work properly (immunodeficiency)
  • Veins in your arm cannot be accessed easily enough for an IV drip
  • You have had a serious allergic reaction, including anaphylaxis, to certain types of antibody-based medicines in the past
  • You have another significant or uncontrolled illness that may make it unsafe for you to participate
  • You have moderate to severe heart failure (confirm with trial site)
  • You currently have an active infection (bacterial, viral, fungal, or other), or you were hospitalised for an infection or treated with intravenous antibiotics within the past 4 weeks, or took oral antibiotics within the past 2 weeks
  • You have a history of cancer, serious opportunistic infections, alcohol or drug misuse, recurring or long-term infections, or blood clotting disorders
  • You have previously taken any approved MS disease-modifying medication, including drugs such as interferons, glatiramer acetate, natalizumab, alemtuzumab, fingolimod, or dimethyl fumarate, among others
  • You received a live or weakened live vaccine within 6 weeks before the start of the study
  • You have previously been treated with certain B-cell targeting therapies, such as rituximab, ocrelizumab, or similar drugs
  • You have previously received certain immune-suppressing, immune-modifying, or cancer-treating drugs, including but not limited to cyclophosphamide, methotrexate, mitoxantrone, or bone marrow transplantation
  • You are currently taking part in another MS drug trial
  • You are taking a medication called fampridine/dalfampridine and your dose has not been stable for at least 30 days before screening
  • You have previously had a serious infusion reaction during treatment with ocrelizumab (this applies to a specific part of the study — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 29 July 2026

Trial contact details on record

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Australian sites

Brain and Mind Centre, Camperdown, New South Wales
Liverpool Hospital, Liverpool, New South Wales
John Hunter Hospital, New Lambton, New South Wales
Royal North Shore Hospital; Department of Neurology, St Leonards, New South Wales
Princess Alexandra Hospital, Woolloongabba, Queensland
Box Hill Hospital; Department of Neurology, Box Hill, Victoria
Austin Hospital; Department of Neurology, Heidelberg, Victoria
Royal Melbourne Hospital; Department of Neurology, Parkville, Victoria
Perron Institute for Neurological and Translational Science, Nedlands, Western Australia

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
24 March 2017
Est. completion
27 April 2023

Where this trial was run

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇭🇷 Croatia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy Kuwait 🇱🇧 Lebanon 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇰 Slovakia 🇸🇮 Slovenia 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 9 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks and 48 Weeks as Measured Using Expanded Disability Status Scale (EDSS); Percentage of Participants With 24-Week and 48-Week Confirmed Disability Improvement (CDI) During the Year 1 Treatment Period, as Measured Using EDSS; Percentage of Participants Event-Free for CDP Sustained for at Least 24 and 48 Weeks at Year 1, as Measured Using EDSS; Percentage of Participants With 24-Week and 48-Week CDI During the Year 2 Treatment Period, as Measured Using EDSS; Percentage of Participants Event-free for CDP Sustain...

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov