The Belimumab Pregnancy Exposure Study: An OTIS Autoimmune Diseases in Pregnancy Project (213928)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50568
• EU PAS number:
  EUPAS49554
• Study ID:
  50568
• Official title and acronym:
  The Belimumab Pregnancy Exposure Study: An OTIS Autoimmune Diseases in Pregnancy Project (213928)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study status:
  Ongoing

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 29/10/2020

Actual: 29/10/2020

Study start date

Planned: 14/12/2022

Actual: 14/12/2022

Date of final study report

Planned: 31/05/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK

Study protocol

Initial protocol

Protocol_Approved_Final_Anonymized.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable