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Rituximab Versus Placebo in People With Secondary Progressive Multiple Sclerosis (RIVITaLISe)



Eligibility Criteria:

Inclusion:

  1. MS as defined by the modified McDonald Diagnostic Criteria (Polman, Reingold et al. 2005)
  2. SP-MS as documented by notes of the referring neurologist: lack of MS relapse for the past 1 year and non-remitting/sustained (> 3 months) progression of disability
  3. Age 18-65, inclusive
  4. EDSS 3.0 to 7.0, inclusive
  5. Willing to participate in all aspects of trial design and follow-up
  6. Lack of CEL on all MRIs performed within the last 12 months or if patient has CEL, then documentation that they tried and failed or could not tolerate FDA approved disease modifying therapies (DMTh)
  7. Not receiving any DMTh (such as IFN-b preparation, glatiramer acetate, corticosteroid, natalizumab, immunosuppressive agents or experimental therapeutics) for a period of at least 3 months before enrollment in the study

Exclusion:

  1. RR-MS or PP-MS
  2. Evidence of clearly documented MS relapse within the last 1 year
  3. Alternative diagnoses that can explain neurological disability and MRI findings
  4. Clinically significant medical disorders that, in the judgment of the investigators, could cause CNS tissue damage, limit its repair, expose the patient to undue risk of harm or prevent the patient from completing the study (such as, but not limited to cerebrovascular disease, ischemic cardiomyopathy, clotting disorder, brittle diabetes, neurodegenerative disorder)
  5. Pregnant or breastfeeding female
  6. History or sign of congenital or acquired immunodeficiency or chronic infections, such as HIV/AIDS, Hepatitis A, B or C, HTLV-1 carrier and others that would expose patient to risks of pathogen reactivation associated with rituximab treatment
  7. Abnormal screening/baseline blood tests exceeding any of the limits defined below:
    • Serum alanine transaminase or aspartate transaminase levels which are greater than three times the upper limit of normal values.
    • Total white blood cell count < 3 000/mm(3)
    • Platelet count < 85 000/mm(3)
    • Serum creatinine level > 2.0 mg/dl and eGFR (glomerular filtration rate) < 60
    • Serological evidence of HIV, HTLV-1 or active hepatitis A, B or C
    • Positive CSF or serum quantitative PCR for JC virus on CSF collected from the baseline spinal tap (test will be performed by CLIA certified laboratory of Gene Major, NINDS)
    • Total serum IgG < 600mg/dl (nl 642-1730mg/dl) or total serum IgM < 30mg/dl (nl 34-342mg/dl) as these Ig deficiencies would suggest underlying abnormalities with B cell function/maturation

Last updated July 17, 2012