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

Completed

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

• Registration Number: NCT06526000
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-11
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States