Phase 3 Multiple Sclerosis Trial, Completed NCT01247324 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 enrolled 821 adults with relapsing multiple sclerosis — 411 received interferon beta-1a (given by injection under the skin, 44 micrograms) and 410 received ocrelizumab. The trial ran for 96 weeks and was primarily measuring how often participants experienced MS relapses over that time. It also looked at several other things, including changes in disability levels and the number of new lesions (areas of damage) visible on brain scans. The reported data shows that, for the main outcome, the interferon beta-1a group had an average of 0.292 relapses per person per year of treatment, while the ocrelizumab group had an average of 0.156 relapses per person per year. For the brain scan results, the total number of a type of active lesion called "T1 gadolinium-enhancing lesions" (spots on the brain that light up on a special scan, suggesting recent activity) was 337 in the interferon group and 21 in the ocrelizumab group across the whole treatment period. The total count of new or growing T2 lesions (another type of scan marker) was 1,916 in the interferon group and 430 in the ocrelizumab group. Regarding disability improvement, 12.42% of eligible participants in the interferon group and 20.00% in the ocrelizumab group showed a confirmed improvement in their disability score over at least 12 weeks. The reported data for the two disability progression time-based outcomes shows "NA" (not available) for both groups, meaning those specific figures were not reported in this dataset. 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

NCT01247324
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 multiple sclerosis (MS), confirmed using the 2010 McDonald criteria
  • You have had at least 2 MS attacks (relapses) in the last 2 years before screening, OR at least 1 attack before that period — but not within the last 30 days before screening
  • Your MS symptoms have been stable for at least 30 days before both the screening and baseline appointments
  • Your level of disability falls within a specific range on a standard MS disability scale (called the EDSS, scored 0 to 5.5) (confirm with trial site)

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 primary progressive MS (the type that worsens steadily from the start without clear relapses)
  • You have had MS for more than 10 years and have very little disability (EDSS score of 2.0 or below) at screening
  • You are unable to have an MRI scan for any reason
  • You have another neurological condition that could look similar to MS
  • You are pregnant or breastfeeding
  • You need long-term steroid or immune-suppressing medication during the study period
  • You have a history of, or currently have, a condition that weakens your immune system
  • You have had a severe allergic or life-threatening allergic reaction to certain types of antibody-based medicines in the past
  • You have an active infection, or a history of serious or long-lasting infections such as hepatitis B or C, HIV, syphilis, or tuberculosis
  • You have a history of a serious brain infection called progressive multifocal leukoencephalopathy (PML)
  • You are unable to take steroid medicines (by mouth or through a drip) for any reason
  • You are unable to use or are not suitable for a medication called Rebif (interferon beta-1a)

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 10 July 2026

Trial contact details on record

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Australian sites

Royal North Shore Hospital; Department of Neurology, St Leonards, New South Wales

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
31 August 2011
Est. completion
2 April 2015

Where this trial was run

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇱 Chile 🇨🇿 Czechia 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇪 Peru 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇷🇸 Serbia 🇸🇰 Slovakia 🇿🇦 South Africa 🇪🇸 Spain 🇨🇭 Switzerland Tunisia 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 1 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks

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: 10 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