Study identification

PURI

https://redirect.ema.europa.eu/resource/49480

EU PAS number

EUPAS30752

Study ID

49480

Official title and acronym

An Observational Study of Ocrelizumab Treated Patients with Multiple Sclerosis to Determine the Incidence and Mortality Rates of Breast Cancer and All Malignancies (VERISMO Study)

DARWIN EU® study

No

Study countries

Germany
United States

Study description

This is a prospective, non-interventional, longitudinal, observational study of multiple sclerosis (MS) patients who have newly initiated treatment with ocrelizumab. Approximately 4000 patients who have initiated treatment with ocrelizumab no more than 30 days prior to study entry, will be followed for a minimum of 5 years following their first exposure to ocrelizumab or until death, whichever comes first. An internal comparator of 2,360 patients newly treated with approved MS disease modifying therapies (DMTs) (per local label) other than ocrelizumab (e.g. alemtuzumab, cladribine, dimethyl fumarate, fingolimod, natalizumab, or teriflunomide) will also be enrolled.

Study status

Ongoing
Research institutions and networks

Institutions

250 centers Germany, 90 centers United States

Contact details

David Wormser

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Roche
Study protocol
Initial protocol

Protocol BA39731 OCREVUS v1_Redacted_final

English (1.95 MB - PDF)View document
Updated protocol

Prot BA39731 ocrelizumab v3, Published Output-1_Redacted

English (1.42 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable