PRIMULA Lac Study: Anifrolumab and Breastfeeding for Lupus
This study, called PRIMULA Lac, is looking at how much anifrolumab (a medicine for lupus) gets into breast milk and how it might affect breastfed babies. Researchers want to understand the levels of anifrolumab in your breast milk and blood, as well as in your baby's blood, if you are breastfeeding and taking anifrolumab for moderate to severe Systemic Lupus Erythematosus (SLE). The study aims to see if anifrolumab passes into breast milk and what effect it has on the baby. The study is currently unclear on its recruitment status and plans to enroll 16 participants.
- Study design
- This is an open-label, open enrollment study. It is designed to assess concentrations of anifrolumab in breast milk and serum.
- What's involved
- If you receive anifrolumab intravenously (IV), you would have milk collected at 14 timepoints and blood drawn on specific days over about one month. If you receive anifrolumab subcutaneously (SC), your participation would last approximately 9 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- For IV administration, maternal and infant serum will be collected around 30 days. For SC administration, the total duration of participation is approximately 9 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Darin Brimhall, MD · PRINCIPAL_INVESTIGATOR · PPD, Las Vegas, US
Who to contact
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What this trial measures
- Area under the milk concentration-time curve during a dosing intervalApproximately 30 days
Area under the milk concentration-time curve during a dosing interval is a component used to assess pharmacokinetic (PK) of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using the concentration-time data for all evaluable participants included in the PK population
- Area under the milk concentration-time curve from time 0 to last quantifiable concentrationApproximately 30 days
Area under the milk concentration-time curve from time 0 to last quantifiable concentration is a component used to assess PK of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using the concentration-time data for all evaluable participants included in the PK population
- Average milk concentration at steady stateApproximately 30 days
Average milk concentration at steady state is a component used to assess PK of anifrolumab in milk of lactating individuals. It will be calculated dividing "Area under the milk concentration-time curve during a dosing interval" by the dosing interval for anifrolumab
- Observed milk concentration at end of dosing intervalApproximately 30 days
Observed milk concentration at end of dosing interval is a component used to assess PK of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using data for all evaluable participants included in the PK population
- Maximum observed milk concentrationApproximately 30 days
Maximum observed milk concentration is a component used to assess PK of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using data for all evaluable participants included in the PK population
- Time of maximum concentrationApproximately 30 days
Time of maximum concentration is a component used to assess PK of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using data for all evaluable participants included in the PK population