Status:
COMPLETED
A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients
Lead Sponsor:
Johns Hopkins University
Conditions:
Primary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Multiple sclerosis (MS) is a chronic inflammatory disorder affecting the central nervous system that is characterized pathologically by focal demyelinating lesions in the brain parenchyma. Meningeal i...
Detailed Description
Multiple sclerosis (MS) is a chronic inflammatory disorder affecting the central nervous system that is characterized pathologically by focal demyelinating lesions in the brain parenchyma. Meningeal i...
Eligibility Criteria
Inclusion
- Diagnosis of PPMS by revised McDonald criteria or SPMS by Lublin and Reingold criteria
- 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
- Severe intolerance of lumbar puncture in the past
- Treatment with a chemotherapeutic agent in the past year or chronic infectious disease
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02253264
Start Date
November 1 2014
End Date
August 1 2017
Last Update
August 30 2017
Active Locations (1)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287