Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106454
• EU PAS number:
  EUPAS106453
• Study ID:
  106454
• Official title and acronym:
  Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry
• DARWIN EU® study:
  No
• Study countries:
  Australia

  France

  Germany

  Ireland

  Spain

  Switzerland

  United Kingdom (Northern Ireland)

  United States
• Study description:
  Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
• Study status:
  Planned

Research institutions and networks

Institutions

Biogen

Study timelines

Date when funding contract was signed

Actual: 21/01/2021

Study start date

Planned: 31/08/2023

Date of final study report

Planned: 18/05/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

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

NCT05658497: https://classic.clinicaltrials.gov/ct2/show/NCT05658497