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)

Study identification

• 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 (1000 patients from the United States and 3000 patients from Germany) who have initiated treatment with ocrelizumab no more than 30 days prior to study entry, will be followed for a minimum of 6.5 years following their first exposure to ocrelizumab or until death, whichever comes first. ; An internal comparator of 1133 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

F. Hoffmann-La Roche

185 centers in Germany and 100 centers in the United States

Study timelines

Date when funding contract was signed

Actual:15/05/2018

Study start date

Planned:17/08/2019

Actual:27/09/2019

Date of final study report

Planned:30/11/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche Ltd

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

BA39731