Status:
COMPLETED
Short-term B-cell Depletion in Relapsing Multiple Sclerosis
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Multiple Sclerosis Society
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
Several disease-modifying therapies (DMTs) have been shown to be effective in reducing the disease activity in patients with relapsing forms of multiple sclerosis (MS) but these treatments, often need...
Eligibility Criteria
Inclusion
- Age 18 years and older.
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS) based on revised McDonald criteria
- At least two Gd-enhancing lesions on the brain or spinal cord MRI done in the prior three months
- Naïve to disease modifying therapies or using an injectable therapy (interferons or glatiramer acetate); or, if history of receiving natalizumab, fingolimod, dimethyl fumarate and teriflunomide, no exposure for past three months
- Expanded Disability Status Scale (EDSS) score at the time of screening =\<3
Exclusion
- Contraindication to treatment with B-cell depleting antibodies, including being seropositive for HBsAg or HIV antibody or T-spot (or Quantiferon-Gold) positive
- Ever received B-cell depleting antibodies (rituximab, ocrelizumab, ofatumumab), alemtuzumab, daclizumab, mitoxantrone or hematopoietic stem-cell transplant
- Female who are pregnant, nursing or unwilling to use contraception up to six months after the second course of the infusion (or 12 months after the first infusion)
- Treatment with steroids in the past 30 days
- Clinically unstable medical or psychiatric disorders at the time of screening that require acute treatment as determined by the PI
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03853746
Start Date
April 1 2019
End Date
July 1 2024
Last Update
February 5 2025
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287