Meta-Analysis Plan for Study Number 201182, GSK1550188, SLE, Pregnancy Analysis

Study identification

• EU PAS number:
  EUPAS11405
• Study ID:
  50499
• Official title and acronym:
  Meta-Analysis Plan for Study Number 201182, GSK1550188, SLE, Pregnancy Analysis
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom

  United States
• Study description:
  The purpose of the study is to evaluate maternal, fetal and infant outcome data for subjects with systemic lupus erythematosus (SLE) who were exposed to belimumab during pregnancy. This is an aggregate analysis of pregnancy outcomes and relevant clinical data from the belimumab clinical trials pulling together data from the clinical trial and safety databases up to 08 March 2014.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 15/12/2014

Actual: 15/12/2014

Study start date

Planned: 15/05/2015

Actual: 29/01/2015

Date of final study report

Planned: 15/11/2015

Actual: 19/11/2015

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)