Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT05131984
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.
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Notify Me18 year and older
All sexes
Observational
Boston, Massachusetts, 02115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg over the course of 1 year
Time frame: 03/2017 - 07/2021
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.
Time frame: 12-24 months from ocrelizumab initiation
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.
Time frame: 12-24 months from ocrelizumab initiation
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.
Time frame: 03/2017 - 07/2021
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.
Time frame: 03/2017 - 07/2021
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.
Brigham and Women's Hospital
Other
Ocrelizumab Treatment Access and Outcomes by Gender, Race, and Socio-economic Status in Multiple Sclerosis Patients: Real World Investigation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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