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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01247324

NCT01247324
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • 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:

  • 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.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Hoffmann-La Roche
Registry
clinicaltrials_gov
Start date
31 August 2011
Est. completion
2 April 2015

Where this trial is recruiting

🇦🇷 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

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov