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

NCT06526000 | Completed

• 1 other identifier: COMB157GUS26
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  Up to 5 years

Secondary Outcomes (3)

• Percentage of Patients Newly Treated with Ocrelizumab With Low Immunoglobulin Values

  Up to 5 years

• 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

Study Arms (1)

Relapsing Multiple Sclerosis Cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: October 11, 2022
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

US (1)