Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 130 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study measures anifrolumab in breast milk and in blood from breastfeeding parents and their babies. It also looks at the drug’s effects on breastfed babies. It is for adults with moderate or severe lupus who are taking anifrolumab.
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who are receiving anifrolumab therapeutically via intravenous (IV) or subcutaneous (SC) administration and evaluate exposure and effects on the breastfed infant.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18, have moderate or severe SLE (lupus), and sign a form agreeing to join.
- Be taking anifrolumab and reach steady drug levels by Day 1: about 85 days after birth, with at least 3 prior doses into a vein or 12 prior doses under the skin after birth.
- Have breastfed or pumped for at least 4 weeks by Day 1.
- Be willing to breastfeed or pump regularly, and only pump during the 24-hour milk collection after the Day 1 dose into a vein.
- Plan to keep feeding breast milk throughout the study, without starting to wean.
- Feed only breast milk, or give no more than 1 bottle of formula a day, from enrollment through the study.
- Agree to use only lanolin nipple cream while samples are collected.
- The baby must have been born at 32 weeks of pregnancy or later. Their weight at birth and enrollment must be above the 10th percentile (higher than the lowest 10% on the growth chart).
Who can't join
- Received an experimental drug, an approved biologic medicine, or a biosimilar (a very similar version) within 30 days before enrollment, or longer if the drug takes longer to leave the body.
- Had lupus nephritis (kidney disease caused by lupus) diagnosed in the past 12 months.
- Had breast implants or surgery to change breast size that greatly affects breastfeeding or milk collection.
- Had cancer in the past 10 years.
- Had a mastectomy (surgery to remove a breast).
- Have mastitis (breast inflammation) or another major active infection before the Day 1 dose.
- The baby has a health problem that the study doctor thinks could make the study unsafe or its results hard to understand. Examples include heart, lung, or liver disease, unstable blood sugar, or an active infection.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Maternal: 1. 18 years or older 2. Signed informed consent to participate 3. Diagnosis of moderate/severe SLE 4. Ongoing treatment with anifrolumab 5. Has reached or will reach steady state (\~85 days postpartum, equivalent to at least 3 consecutive previous IV doses or at least 12 previous SC doses during the post-partum period) with anifrolumab by the time of study Day 1 (pre-dose milk collection) 6. Established lactation in the index post-partum period (breastfeeding or pumping for at least 4 weeks at time of Day 1 visit to ensure mature milk production) 7. Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection on Day 1 post IV dose 8. Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning 9. Must be exclusively breast milk-feeding their infant (or if not exclusively breast milk-feeding, not providing more than 1 supplemental bottle of formula per day) at the time of enrollment and throughout the study period 10. Agrees to use only lanolin nipple cream during the sampling period Infant: 1. Gestational age at delivery ≥32 weeks 2. Birthweight \> 10th percentile 3. Weight \> 10th percentile at the time of enrollment Exclusion Criteria: Maternal: 1. Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives (whichever is longer) prior to enrollment in the study 2. Diagnosis of lupus nephritis in the last 12 months 3. History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts 4. History of malignancy in the last 10 years 5. History of mastectomy 6. Evidence of mastitis or any other significant active infection at Day 1 (pre-dose) Infant: 1\. Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant participant at risk by participating in the study
Study sites (1)
NV
- Research Site · Las Vegas, NV 89113More trials in Las Vegas