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Study to Assess Changes in Immunoglobulins in Patients With Relapsing Multiple Sclerosis Treated With Anti-CD20 Therapies

NCT06526000

CompletedN/A

Sponsor: Novartis

Conditions: Relapsing Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing-remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

Countries: United States

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) newly initiating anti-CD20 monoclonal antibody treatment in clinical practice. The index date was defined as the date of anti-CD20 drug initiation during the study period. The baseline period was defined as 12 months prior to the index date.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

East Hanover, New Jersey, United States