Posted Friday, January 20, 2012
News from the National Multiple Sclerosis Society
Summary:Investigators worldwide are recruiting a total of 1,600 people with relapsing MS for two phase III studies comparing the effectiveness of intravenous ocrelizumab (Genentech) versus Rebif® (interferon beta-1a, EMD Serono & Pfizer). Ocrelizumab, an experimental therapy, is also being tested in primary-progressive MS.
Rationale: Ocrelizumab is a monoclonal antibody that binds to a molecule (CD20) on the surface of select B cells and depletes them from the body. B cells are immune cells that make antibodies and conduct other functions, and play a role in the immune attack on the brain and spinal cord in MS. The drug is a humanized antibody, similar to rituximab, a human/mouse antibody to CD20 that has previously shown benefit in people with relapsing-remitting MS, and had mixed results in primary-progressive MS. In an ongoing proof-of-concept study in relapsing-remitting MS, 2 doses of ocrelizumab were tested (600 mg and 2000 mg). Both were found to significantly reduce disease activity as measured by brain MRI (magnetic resonance imaging) scans and clinical attacks (relapses) versus placebo. One person on the higher dose (2000 mg) died due to consequences of liver and kidney failure; the relation of this death to the study medication is unclear. (The Lancet, published online November 1, 2011).
Eligibility and Details: Participants in either study should be ages 18 to 55, with a diagnosis of relapsing MS. More details on the enrollment criteria for both studies are available from the contact below.
In each study, participants are being randomly assigned to receive ocrelizumab (2 intravenous infusions of 300 mg separated by 14 days or single infusions of 600 mg in each 24-week treatment cycle) or Rebif (8 to 44 micrograms three times weekly subcutaneously) for 96 weeks. Participants in the ocrelizumab group will receive an inactive placebo version of Rebif, and those in the Rebif group will get an inactive placebo version of ocrelizumab.
In each study, the primary outcome being measured is the effect on relapse rates. Secondary outcomes include time to onset of sustained disability progression (an increase in the EDSS disability scale that is sustained for at least 12 weeks), change in disease activity on MRI scans, change in brain tissue volume, and safety and tolerability.
Read full article on the National MS Society's website
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