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

Novartis

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06526000

COMB157GUS26

Details and patient eligibility

About

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.

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

326 participants in 1 patient group

Relapsing Multiple Sclerosis Cohort

Description:

Patients with relapsing forms of multiple sclerosis who had newly initiated anti-CD20 treatment after March 2017.