Ocrelizumab Access by Socio-Economic Status

NCT ID: NCT05131984

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2023-07-01

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.

Detailed Description

This study will be a two-center retrospective/observational analysis with data collected from the Research Patient Data Registry (RPDR), Brigham Multiple Sclerosis Center Patient Database (Oracle), and Boston Medical Center MS Clinic Database (BMC-MS).

Using the Oracle database, BMC-MS database and electronic medical records (EPIC), the investigators will capture all MS patients who satisfy inclusion criteria. This study will collect age, sex, race, socio-economic status by residence zip code, disease duration, previous treatment, current treatment status, the reason for discontinuing or switching to another treatment, expanded disability status scale (EDSS), and functional systems scores (FSS) where available.

Additionally, the investigators will collect the date, dose, and interval between each ocrelizumab infusion, as well as any pertinent laboratory values and MRI scan results.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Ocrelizumab

Intervention Type: 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

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.

Ocrelizumab

Intervention Type: 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

Interventions

Ocrelizumab

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maria Houtchens

Neurologist, Director of the Clinical Care, Multiple Sclerosis Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P002772

Identifier Type: -

Identifier Source: org_study_id