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

July 23, 2024 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Relapsing Multiple Sclerosis Cohort
Patients with relapsing forms of multiple sclerosis who had newly initiated anti-CD20 treatment after March 2017.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years
Percentage Change per Year in Immunoglobulin M (IgM) Levels in Patients Receiving Ocrelizumab
Time Frame: Up to 5 years
Up to 5 years
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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMB157GUS26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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