Long-Term Surveillance of Ocrelizumab Treated Patients With Multiple Sclerosis (MANUSCRIPT Study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31380
• EU PAS number:
  EUPAS28619
• Study ID:
  31380
• Official title and acronym:
  Long-Term Surveillance of Ocrelizumab Treated Patients With Multiple Sclerosis (MANUSCRIPT Study)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Denmark

  France

  Germany

  Italy

  Sweden
• Study description:
  This longitudinal observational study is part of the European Union (E.U.) risk management plan and is designed to further assess the long-term safety profile of ocrelizumab in the real world setting. The study will provide safety data for a 10 year period after ocrelizumab launch, specifically targeting the rate of SAEs, including serious infections and malignancies.
• Study status:
  Ongoing

Research institution and networks

Institutions

F. Hoffmann-La Roche

Study timelines

Date when funding contract was signed

Actual: 01/06/2017

Study start date

Planned: 01/08/2019

Actual: 15/07/2019

Data analysis start date

Planned: 14/04/2028

Date of final study report

Planned: 31/01/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche

Study protocol

Initial protocol

Protocol BA39730 ocrelizumab Final v1_approved_Redacted

Updated protocol

Prot BA39730 ocrelizumab v1, Published_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

BA39730