Department of Neurology

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Department of Neurology

Nabs Study

A randomized, controlled, open-label parallel Group study to evaluate the effect of regularly scheduled neutralizing antibody testing on treatment patterns versus usual care in high-dose interferon treated subjects to determine the impact of regularly scheduled neutralizing antibody (NAb) testing on treatment patterns compared to the usual care of MS subjects receiving high-dose IFN therapy.

Study duration
Regularly Scheduled Nab Testing Arm: Subjects will be followed-up for 12 months. Up to four BAb +/- NAb tests will be performed in subjects in this arm during the study.  
Usual Care Arm: Subjects will be followed-up for 12 months under usual care conditions

Key Inclusion Criteria

  1. Willing to provide informed consent
  2. Male or female, 18 years of age or older, with a diagnosis of MS.
  3. On high-dose interferon therapy for < 12 months, with no more than a 60 day cumulative interruption of treatment, to < 4 years. (Must be on the same high-dose IFN for at least on year). High dose interferon is defined as Rebif or Betaseron at approved doses.
  4. Willing to have blood draw for binding antibody (Bab) and neutralizing antibody tests (Nab) (preferably, from a blood sample drawn 24 hours or more after last administration of IFN). 
  5. Willing and able to complete all procedures and evaluations related to the study including a blood draw for Bab +/- Nab testing at baseline and 2 or more Bab +/-Nab tests during the study. 

Key Exclusion Criteria

  1. Has been on oral or parenteral corticosteroid therapy within the two weeks prior to the baseline visit
  2. Has been treated with immunoglobulins (IgG) or plasmapheresis within the last six months
  3. Is currently being treated with any IFN other than Rebif or Betaseron at approved doses. 
  4. Is using an immune disease modulator (such as Copaxone) or any immunosuppressant such as mitoxantrone, methotrexate, cyclophosphamide, azathioprine, penicillamine, hydroxychloroquine, cyclosporine, natalizumab, adalimumab, etc. 
  5. Has ever had Nab testing performed in the past
  6. Has any condition which the investigator or nurse feels may interfere with participation in the study or with assessments for the full duration of the study
  7. Previously participated in this study
  8. Has received an experimental drug in the last thirty (30) days

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