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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

326 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-11

Study Completion Date

2024-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Relapsing Multiple Sclerosis Cohort

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No