Clinical Trial Details
Braintumor Website

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NCT02253264 : A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Diagnosis of PPMS by revised McDonald criteria or SPMS by Lublin and Reingold

- Age ? 18 years

- MRI Brain demonstrating evidence of leptomeningeal enhancement on contrast enhanced
FLAIR images within the past 12 months, which is now part of the routine clinical MS
MRI protocol at the Johns Hopkins Hospital.

- Patients may be on no MS treatment or should have been on the same treatment for at
least 6 months and are not expected to switch therapy in the next 6 months

Exclusion Criteria:

- Severe intolerance of lumbar puncture in the past

- Treatment with a chemotherapeutic agent in the past year or chronic infectious

- Peripheral CD19 counts below lower limit of normal in patients previously treated
with rituximab

- Calculated creatinine clearance ? 70 ml/min calculated using Cockroft-Gault equation

- Female patients of childbearing potential not willing to use contraception
(intrauterine device (IUD), oral contraceptive pill (OCP) or double barrier method)

- Corticosteroid treatment within the past 30 days

- Known history of other neuroinflammatory or systemic autoimmune disease

- Known bleeding diathesis or ongoing anticoagulation (oral/ injectable)

- Receipt of live vaccination within 1 month prior to scheduled study drug dosing

- Hemoglobin < 10 mg/dL, or Platelet count < 100,000 /mm3 or white blood count (WBC) <
2,000 or > 15,000 /mm3

- Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5× the site
laboratory upper limit of normal (ULN) or Total bilirubin > 2.5 ULN

- Positive for Hepatitis B surface antigen (HBsAg) or Positive for Hepatitis C antibody
(HCV Ab)

- Moderate or severe acute illness with or without fever

- Current use (or use within the past 3 months) of natalizumab as MS therapy
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