Last updated on April 2013

A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple Sclerosis


Brief description of study

A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple Sclerosis

Detailed Study Description

Patient Inclusion Criteria:

  • Ages 18-60
  • SPMS diagnosis
  • Must be able to walk
  • Diagnosed with MS as defined by the modified McDonald criteria
  • SPMS defined as relapsing-remitting disease with recent progression in MS-related neurological deficits
  • EDSS score 3.0 - 6.0, inclusively
  • Presence of myelin reactive T-cells

Patient Exclusion Criteria:

  • Diagnosed with primary progressive MS
  • Treatment with beta-interferon or glatiramer acetate 30 days prior to starting study treatment
  • Treatment with ACTH, any over-the-counter or prescription corticosteroids 60 days prior to screening
  • Treatment with IVIG, plasmapheresis or cytopheresis 90 days prior to screening
  • Treatment with mitoxantrone, teriflunomide, fingolimod, natalizumab, azathioprine, cyclosporine, methotrexate or mycophenolate mofetil 1 year prior to screening
  • Any prior treatment with cladribine, cyclophosphamide, total lymphoid irradiation, T cell or T cell receptor products, or any therapeutic monoclonal antibody, except natalizumab
  • Previous treatment with any other investigational drug 1 year prior to screening
  • HIV or hepatitis infection
  • History of cancer
  • Any other significant medical condition that, in the opinion of the investigator, could cause CNS tissue damage or limit its repair.

Clinical Study Identifier: TX136802

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Recruitment Status: Open


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