Satralizumab Single-Arm Pregnancy Safety Study: A Global, Observational, Single-Arm, 10-Year Study of Pregnancy and Infant Outcomes in Satralizumab-Exposed Women With Neuromyelitis Optica Spectrum Disorder

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47981
• EU PAS number:
  EUPAS47980
• Study ID:
  47981
• Official title and acronym:
  Satralizumab Single-Arm Pregnancy Safety Study: A Global, Observational, Single-Arm, 10-Year Study of Pregnancy and Infant Outcomes in Satralizumab-Exposed Women With Neuromyelitis Optica Spectrum Disorder
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Germany

  Italy

  United States
• Study description:
  This is a global, non-interventional, single-arm, 10-year study on the safety of satralizumab in women with Neuromyelitis Optica Spectrum Disorder (NMOSD) and their infants exposed to the study drug during the 6 months prior to the last menstrual period (LMP) or at any time during the pregnancy. The study will collect primary data from satralizumab-exposed pregnant women, their obstetric provider, and their satralizumab prescriber, as well as from the infant’s health care provider (HCP) throughout the first year of life for live births. Maternal, fetal, and infant adverse outcomes will be described.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned: 15/08/2022

Actual: 15/08/2022

Study start date

Planned: 01/09/2022

Actual: 22/11/2022

Date of final study report

Planned: 31/12/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Hoffmann-La Roche

Study protocol

Initial protocol

study-wn42856_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

WN42856