Status:
COMPLETED
Study to Assess Changes in Immunoglobulins in Patients With Relapsing Multiple Sclerosis Treated With Anti-CD20 Therapies
Lead Sponsor:
Novartis
Conditions:
Relapsing Multiple Sclerosis
Clinically Isolated Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
This was an observational retrospective cohort study using electronic medical records (EMRs) to study immunoglobulin levels over time among patients with relapsing forms of multiple sclerosis (MS) new...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients aged 18 years or older at index.
- Patients with RMS, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and secondary progressive multiple sclerosis (SPMS) at the time of initiating anti-CD20 treatment.
- Newly initiated anti-CD20 treatment after March 2017 (no history of anti-CD20 therapy at any time in medical record before this date) to the latest data cutoff (November 2022).
- Patients with at least one documented IgG lab value pre- and post-anti-CD20 drug initiation.
- Exclusion criteria:
- Patients with diagnosis of primary progressive multiple sclerosis (PPMS) prior to anti-CD20 treatment.
- Participated in an anti-CD20 drug clinical trial during the study period.
Exclusion
Key Trial Info
Start Date :
October 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT06526000
Start Date
October 11 2022
End Date
February 28 2024
Last Update
July 29 2024
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936