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

Retrospective EMR Study to Assess Changes in Immunoglobulins in Patients With Relapsing Forms of Multiple Sclerosis Treated With Anti-CD20 Monoclonal Antibodies

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06526000

Enrollment

326

Registered

2024-07-29

Start date

2022-10-11

Completion date

2024-02-28

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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) 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Percentage Change per Year in Immunoglobulin G (IgG) Levels in Patients Receiving Ocrelizumab	Up to 5 years

Secondary

Measure	Time frame	Description
Percentage of Patients Newly Treated with Ocrelizumab With Low Immunoglobulin Values	Up to 5 years	Low immunoglobulin values were defined as greater than or equal to 1 immunoglobulin G (IgG) lab value of less than 500 milligrams per deciliter (mg/dL) or greater than or equal to 1 immunoglobulin M (IgM) lab value of less than 25 mg/dL.
Percentage Change per Year in Immunoglobulin M (IgM) Levels in Patients Receiving Ocrelizumab	Up to 5 years	—
Percentage Change per Year in IgG Levels Associated With Risk Factors in Patients Treated With Ocrelizumab	Up to 5 years	Risk factors included: age and disease duration.

Countries

United States

Outcome results