Phase 3 Multiple Sclerosis Trial, Completed NCT01194570 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 looked at a drug called ocrelizumab (600 mg) compared to a placebo (an inactive treatment) in people with primary progressive multiple sclerosis. A total of 732 people took part — 244 in the placebo group and 488 in the ocrelizumab group. The trial was mainly measuring how long it took for participants to experience a confirmed worsening of their disability, as measured by a standard MS disability scale (where 0 means no disability and 10 means death from MS), with that worsening needing to last at least 12 weeks. The reported data shows that for the two main time-to-disability-worsening measures — one confirmed at 12 weeks and one at 24 weeks — the results were listed as "NA" (not available), meaning specific time figures were not reported in the submitted data. For the secondary outcomes where numbers were provided: the reported data shows that walking speed (measured by a timed 25-foot walk test) worsened on average by about 55% from the start in the placebo group, compared to about 39% in the ocrelizumab group. The volume of lesions visible on brain scans (areas of damage) increased by about 7.4% in the placebo group, while it decreased by about 3.4% in the ocrelizumab group. Overall brain volume change (measured from week 24 to week 120) was reported as a decrease of about 1.09% in the placebo group and about 0.90% in the ocrelizumab group. The reported data also shows that a self-reported quality-of-life score focused on physical health (on a 0–100 scale where higher means less disability) changed by about −1.1 points in the placebo group and about −0.7 points in the ocrelizumab group from the start of the trial to week 120. It is worth noting that a large proportion of participants in both groups did not complete the study — 155 out of 244 in the placebo group and 270 out of 488 in the ocrelizumab group — though the reasons were not detailed 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, Completed

NCT01194570
Completed 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 diagnosed with primary progressive multiple sclerosis (PPMS), confirmed using specific medical guidelines called the revised McDonald criteria
  • Your level of physical disability, measured on a standard MS scale (EDSS), scores between 3 and 6.5 at the time of screening
  • If your disability score is above 5.0, your MS symptoms must have started less than 15 years ago; if your score is 5.0 or higher, your symptoms must have started less than 10 years ago (confirm with trial site)
  • If you are sexually active and could potentially father or become pregnant, you must be willing to use two forms of contraception during the study and for 48 weeks after your last dose

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 different type of MS, such as relapsing-remitting, secondary progressive, or progressive relapsing MS
  • You are unable to have an MRI scan for any reason
  • You have another known condition affecting the nervous system or brain
  • You have a current infection, or a history of frequent or long-lasting infections
  • You have a history of cancer of any kind, except certain minor skin cancers or cervical in-situ cancer that have been fully removed and resolved
  • You have previously been treated with certain medicines that target B-cells, such as rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab
  • You have previously received certain other immune-affecting treatments, including alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, bone marrow transplant, or several others (confirm full list with trial site)
  • You have another condition that would require long-term use of steroid or immune-suppressing medicines during the study

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 21 July 2026

Trial contact details on record

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Australian sites

Royal Hobart Hospital, Hobart, Tasmania
St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research, Fitzroy, Victoria

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

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
2 March 2011
Est. completion
23 July 2015

Where this trial was run

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇱🇹 Lithuania 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇿 New Zealand 🇳🇴 Norway 🇵🇪 Peru 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇪🇸 Spain 🇨🇭 Switzerland 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 2 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 Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period

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: 21 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