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Clinical Trial: Malignancies and MS Treatment

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Details
Type of MS: PPMS|PRMS|RRMS|SPMS
Treatment mode of action: n/a
Number of Subjects: 46
Medication: Ocrelizumab (Ocrevus®), Alemtuzumab (Lemtrada®), Cladribine (Mavenclad®), Dimethyl fumarate (Tecfidera®), Fingolimod (Gilenya®), Natalizumab (Tysabri®
Location: Massachusetts
Institutions: Massachusetts General Hospital
165 Cambridge St, 6th Floor
Boston, MA 02114
  Contact Information
Dylan Rice
(617) 643-2947
drice2@partners.org

Funding:

F. Hoffman La Roche

Description

VERISMO is a long-term, observational safety study of patients who are newly starting Ocrevus, or Lemtrada, Mavenclad, Tecfidera, Gilenya, Tysabri, or Aubagio. The goal of the study is to determine the full safety profile of Ocrevus compared to these other MS DMTs (disease modifying therapies), with a special focus on the rates of all malignancies (cancers) and especially breast cancers.

People who enroll in VERISMO will have a one-time visit with the study coordinator to sign the study consent form. This visit should not last longer than 15-30 minutes. If a person decides to enroll, they will be followed for at least 5 years. This means that every time they see their neurologist, the study coordinator will abstract de-identified data from the electronic medical record. This data will include height, weight, age, sex, MS disease characteristics, and any safety events. Participants have to be patients at a Partners Hospital to be eligible for this study (e.g. MGH, BWH, Newton-Wellesley, etc).

Data from all 4000 patients globally will be collected by Roche and analyzed to determine the full, long-term safety profile of Ocrevus versus other MS DMTs. Because participation in this study lasts for 5 years for each individual, it is anticipated that the study will be complete in 2030.

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