Ocrelizumab Access by Socio-Economic Status

Multiple Sclerosis Clinical Trial

Official title:

Ocrelizumab Treatment Access and Outcomes by Gender, Race, and Socio-economic Status in Multiple Sclerosis Patients: Real World Investigation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05131984
• Other study ID #: 2021P002772
• Status: Not yet recruiting
• Start date: November 15, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2021
• Source: Brigham and Women's Hospital
• Contact: Maria Houtchens, MD
• Phone: 6175256550
• Email: mhoutchens[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: October 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Boston Medical Center, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Effects	Evaluation of the prevalence of adverse effects in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS.	03/2017 - 07/2021
Other	Treatment Discontinuation	Evaluation of the reasons for and timing of discontinuation of treatment with ocrelizumab in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS.	03/2017 - 07/2021
Primary	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	Annualized relapse rate	Annualized relapse rate over 12 and 24 months in men and women of different racial and ethnic origins and socio-economic backgrounds in patients with RRMS.	12-24 months from ocrelizumab initiation
Secondary	MRI Changes	New T2 and new T1 gadolinium enhancing lesions over 12 and 24 months in men and women of different racial and ethnic origins and socio-economic backgrounds in patients with RRMS.	12-24 months from ocrelizumab initiation