BridgeMD
New treatment option for Systemic Lupus Erythematosus
Official title Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
ClinicalTrials.gov ID: NCT06594068
What this study is testing
What is Anifrolumab?
Anifrolumab is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130, women only
You may be able to join if
- Maternal:
- 18 years or older
- Signed informed consent to participate
- Diagnosis of moderate/severe SLE
- Ongoing treatment with anifrolumab
You likely can't join if
- Maternal:
- Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives (whichever is longer) prior to enrollment in...
- Diagnosis of lupus nephritis in the last 12 months
- History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or...
- History of malignancy in the last 10 years
- History of mastectomy
See the full eligibility criteria
- Maternal:
- 18 years or older
- Signed informed consent to participate
- Diagnosis of moderate/severe SLE
- Ongoing treatment with anifrolumab
- 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...
- 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)
- 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
- Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning
- 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
- Agrees to use only lanolin nipple cream during the sampling period Infant:
- Gestational age at delivery ≥32 weeks
- Birthweight \> 10th percentile
- Weight \> 10th percentile at the time of enrollment
- Maternal:
- 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
- Diagnosis of lupus nephritis in the last 12 months
- History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
- History of malignancy in the last 10 years
- History of mastectomy
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Las Vegas, Nevada, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Las Vegas, Nevada, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.