Ocrelizumab Access by Socio-Economic Status

NCT05131984 | Completed FDA Drug

• 1 other identifier: 2021P002772
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this project is to determine whether there are differences in access to, efficacy and tolerability of Ocrelizumab in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS in two large academic MS Centers with a high volume of patients on Ocrelizumab. The study is a retrospective analysis of multiple sclerosis patients cared for at Brigham and Women's Hospital and Boston Medical Center who were treated with Ocrelizumab during the 4 year study period.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Time to treatment initiation

  Time from diagnosis to Ocrelizumab treatment initiation in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS.

  03/2017 - 07/2021

Secondary Outcomes (2)

• Annualized relapse rate

  12-24 months from ocrelizumab initiation

• MRI Changes

  12-24 months from ocrelizumab initiation

Other Outcomes (2)

• Adverse Effects

  03/2017 - 07/2021

• Treatment Discontinuation

  03/2017 - 07/2021

Study Arms (2)

Multiple Sclerosis patients on Ocrelizumab at Brigham and Women's Hospital

All MS patients at the Brigham MS Center who have been diagnosed with relapsing remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (PPMS), ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period.

Drug: Ocrelizumab

Multiple Sclerosis patients on Ocrelizumab at Boston Medical Center

All MS patients at the Boston Medical Center MS Clinic who have been diagnosed with RRMS or PPMS, ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period.

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

At least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg over the course of 1 year

Multiple Sclerosis patients on Ocrelizumab at Boston Medical Center; Multiple Sclerosis patients on Ocrelizumab at Brigham and Women's Hospital

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

Adult patients with relapsing remitting or primary progressive MS evaluated at Brigham and Women's Multiple Sclerosis Clinic or Boston Medical College Multiple Sclerosis Clinic between 03/2017 and 07/2021 who were started on ocrelizumab in that time period.

You may qualify if:

• All MS patients at the Brigham MS Center and Boston Medical Center MS Clinic who have been diagnosed with RRMS or PPMS, ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period.

You may not qualify if:

• Simultaneous use of high dose monthly IV steroids,
• Secondary progressive MS (SPMS) disease category,
• Additional serious medical or neurologic co-morbid diseases,
• Additional concomitant immunosuppressive therapy of any kind,
• Additional concomitant MS-specific therapy (DMT) of any kind,
• Change of infusion or care site and absence of neurologic or imaging follow-up.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Genentech, Inc.: collaborator
• Boston Medical Center: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist, Director of the Clinical Care, Multiple Sclerosis Center

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 23, 2021
• Study Start: November 18, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)