Systemic lupus erythematosus (SLE)
Conditions
Brief summary
1. Plasma concentration of DZP in the infants at birth, 2. Plasma concentration of DZP in mothers at delivery, 3. Ratio between plasma concentration of DZP between the infants and mother at birth/delivery
Detailed description
1. Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum, 2. Predose and postdose plasma concentrations of DZP in mothers during pregnancy, 3. DZP plasma concentrations at 12 and 14 Weeks postpartum in mothers continuing DZP treatment postpartum, 4. DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum, 5. Treatment-emergent adverse events (TEAEs) of mothers, 6. Serious TEAEs of mothers, 7. TEAEs of special interest of mothers, 8. TEAEs of special monitoring of mothers, 9. AEs of infants, 10. Serious AEs of infants, 11. AEs of special interest of infants, 12. AEs of special monitoring of infants, 13. Pregnancy outcome, 14. Predicted area under the curve (AUC) over the dosing interval at steady state across the second and third trimesters of pregnancy, 15. Predicted trough plasma concentration (Ctrough) over the dosing interval at steady state across the second and third trimesters of pregnancy, 16. Predicted maximum plasma concentration (Cmax) over the dosing interval at steady state across the second and third trimesters of pregnancy, 17. Predicted AUC over the dosing interval at steady state across the postpartum, 18. Predicted Ctrough over the dosing interval at steady state across the postpartum, 19. Predicted Cmax over the dosing interval at steady state across the postpartum
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plasma concentration of DZP in the infants at birth, 2. Plasma concentration of DZP in mothers at delivery, 3. Ratio between plasma concentration of DZP between the infants and mother at birth/delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum, 2. Predose and postdose plasma concentrations of DZP in mothers during pregnancy, 3. DZP plasma concentrations at 12 and 14 Weeks postpartum in mothers continuing DZP treatment postpartum, 4. DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum, 5. Treatment-emergent adverse events (TEAEs) of mothers, 6. Serious TEAEs of mothers, 7. TEAEs of special interest of mothers, 8. TEAEs of special monitoring of mothers, 9. AEs of infants, 10. Serious AEs of infants, 11. AEs of special interest of infants, 12. AEs of special monitoring of infants, 13. Pregnancy outcome, 14. Predicted area under the curve (AUC) over the dosing interval at steady state across the second and third trimesters of pregnancy, 15. Predicted trough plasma concentration (Ctrough) over the dosing interval at steady state across the second and third trimesters of pregnancy, 16 | — |