Natalizumab in SPMS

In response to one of yesterday's comments:

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS (ASCEND in SPMS)



Eligibility

Criteria
Major Inclusion Criteria
:

Major Exclusion Criteria:
Treatment History
  • Any prior treatment with cell-depleting therapies, including total lymphoid irradiation, cladribine, rituximab, alemtuzumab, or bone marrow ablation.
  • Any prior treatment with natalizumab.
  • Treatment with mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, T cell or T cell receptor vaccination, fingolimod, daclizumab, or cytapheresis within 6 months prior to randomization.
  • Treatment with IV or oral corticosteroids, intravenous immunoglobulin (IVIg), or plasmapheresis for treatment of MS within the 3 months prior to randomization.
  • Treatment with glatiramer acetate or any interferon beta preparations within 4 weeks prior to randomization.
  • Treatment with 4-aminopyridine within 30 days prior to randomization, unless a stable dose has been maintained for at least 30 days prior to randomization and will be continued for the course of this study.

This short YouTube video from Biogen-Idec and Elan explains how the drug works. Some of you may find it helpful. 

"A Big Pharma Trial in SPMS; I would rate the chances of this study being positive as being >80%. Why? Because the drug is very effective at switching of relapses and MRI activity, i.e. it is a powerful anti-inflammatory drug and inflammation still plays a part in SPMS."

CoI: Multiple