Long-term surveillance of patients with multiple sclerosis to report progressive multifocal leukoencephalopathy and other serious opportunistic infections among patients treated with natalizumab

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45446
• EU PAS number:
  EUPAS45445
• Study ID:
  45446
• Official title and acronym:
  Long-term surveillance of patients with multiple sclerosis to report progressive multifocal leukoencephalopathy and other serious opportunistic infections among patients treated with natalizumab
• DARWIN EU® study:
  No
• Study countries:
  Czechia
• Study description:
  The primary objective of the study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) and serious adverse events (SAEs) of other opportunistic infections (OIs) among all subjects taking natalizumab.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Biogen

Study timelines

Date when funding contract was signed

Planned: 01/10/2019

Actual: 10/12/2019

Study start date

Planned: 01/01/2019

Actual: 01/01/2019

Date of final study report

Planned: 30/04/2025

Sources of funding

EU institutional research programme

Other

More details on funding

Biogen

Regulatory

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