WEUKBRE6076: Benlysta Pregnancy Registry (BPR) - Prospective cohort study of pregnancy outcomes following Benlysta exposure within 4 months prior to and/or during pregnancy (114256)

Study identification

• EU PAS number:
  EUPAS6577
• Study ID:
  50563
• Official title and acronym:
  WEUKBRE6076: Benlysta Pregnancy Registry (BPR) - Prospective cohort study of pregnancy outcomes following Benlysta exposure within 4 months prior to and/or during pregnancy (114256)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Canada

  France

  Germany

  Israel

  Italy

  Portugal

  Spain

  Sweden

  Switzerland

  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharmaceutical Product Development (PPD)

Study timelines

Date when funding contract was signed

Planned:21/07/2011

Actual:21/07/2011

Study start date

Planned:16/07/2012

Actual:16/07/2012

Date of final study report

Planned:17/07/2023

Actual:26/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

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)