Skip to main content
OpenTrials
Completed

NCT Number: NCT06526000

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapsing Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Clinically Isolated Syndrome Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Relapsing-Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage Change per Year in Immunoglobulin G (IgG) Levels in Patients Receiving Ocrelizumab

    Time frame: Up to 5 years

Secondary outcomes

  1. Percentage of Patients Newly Treated with Ocrelizumab With Low Immunoglobulin Values

    Time frame: 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.

  2. Percentage Change per Year in Immunoglobulin M (IgM) Levels in Patients Receiving Ocrelizumab

    Time frame: Up to 5 years

  3. Percentage Change per Year in IgG Levels Associated With Risk Factors in Patients Treated With Ocrelizumab

    Time frame: Up to 5 years

    Risk factors included: age and disease duration.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.