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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Pregnancy registry
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Multi-center, prospective study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BELIMUMAB
• Medical condition to be studied:
  Pregnancy

Population studied

• Short description of the study population:
  The study population included pregnant women with systemic lupus erythematosus (SLE) exposed to belimumab within the 4 months prior to and/or during pregnancy. ; Minimum criteria for enrolment will be the following: ;  For belimumab exposed pregnant women: Sufficient evidence to confirm that exposure to commercially supplied belimumab occurred within the 4 months prior to and / or during pregnancy (“belimumab exposed”); Or;  For belimumab unexposed pregnant women: ; Any women who became pregnant during the SABLE protocol and was not exposed to belimumab: Sufficient evidence to confirm that exposure to belimumab did not occur within 4 months prior to and / or during pregnancy (“unexposed”)
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To evaluate pregnancy and infant outcomes for pregnancies in women with systemic lupus erythematosus exposed to belimumab within the 4 months prior to and/or during pregnancy
• Outcomes:
  Birth defect prevalence, Infant outcomes and other pregnancy outcomes
• Data analysis plan:
  Descriptive statistics will be performed for all prospective, evaluable data. The summary statistics for continuous and categorical variables to be used will be specified in the Reporting and Analysis Plan (RAP) but may include means, standard deviations, medians, minimums, maximums, percentiles, and percentages. Frequencies and proportions of adverse pregnancy outcomes, birth defects, serious and/or clinically significant infections in infants will be calculated with corresponding 95% confidence intervals. For the primary endpoint of birth defect prevalence, the estimates of birth defect prevalence from MACDP and EUROCAT will be used to represent external population comparators. The differences between the observed registry birth defect rates and these comparators will be estimated along with 95% confidence intervals.