Anifrolumab Breastfeeding Study
Join the study to help other patients, researchers, and doctors learn about the safety of SAPHNELO™ (anifrolumab) when used by breastfeeding individuals with lupus.
This study collects health information, milk samples, and blood samples from breastfeeding individuals taking prescription medications and from their exclusively breastfed infants.
Would you like to participate?
Contact the study today
Am I eligible?
You may be eligible if you are:
- Aged 18 years or older
- A resident of the United States
- Currently taking or planning to take SAPHNELO™ (anifrolumab) for your lupus
- Pregnant or breastfeeding and planning to continue feeding your infant only breast milk (via breast or pumping) for at least 30 days
- Your baby was born at 32 weeks of gestation or after
- Your baby had an average weight at the time of birth
- Your baby has an average weight now
Note: For this study we define average weight as >10th percentile weight-for-age. You can check here if you are not sure.
What is SAPHNELO™ (anifrolumab)?
SAPHNELO™ (anifrolumab) is a prescription medication made by AstraZeneca AB and used for the treatment of moderate/severe systemic lupus erythematosus in adults.
How do I participate?
Complete the Contact Request Form here and a study team member will contact you
Email the study team with your contact information at:
crganifrolumabbreastfeedingstudy@thermofisher.com
Call the study team voicemail toll-free at 877-311-3793 and leave your name and number (you can call at any time of the day to leave a message, your call will be returned during the operation hours 8:30 am – 5:00 pm EST Monday-Friday)
All participants have access to free breastfeeding support through a certified lactation consultant.
All study activities can be done from the comfort of your home. There are no clinic visits required.
If you already have an electric breast pump at home, you can use your pump to collect milk samples for this study. If you do not have a pump, we will mail a pump to you at no cost, along with instructions on how to use it.
If you are eligible and would like to participate, you will be asked to:
1. Provide your consent (the requirement for participation in any research study)
2. Provide health information about you and your infant
3. Provide milk samples before and after receiving SAPHNELO™ (anifrolumab) treatment. All milk you produce during the 24 hours immediately after your treatment will be collected for research. After the first 24 hours, milk will be collected once a day on a total of 8 days.
4. Provide blood samples before and after receiving SAPHNELO™ (anifrolumab) treatment. A total of three blood samples will be collected from you throughout the study.
5. A small amount of blood will be taken from your infant’s heel once at the end of the 30-day study. This will be done by a certified nurse in the comfort of your home.
Will I be paid for my participation?
You will be compensated for your participation in the study.
For completing Day 1 $250
For completing Day 12 $175
For completing Day 30 $175
If you complete all the required study procedures, you will receive a total of $600 for your participation. Payments will be made via bank transfer, PayPal, ScoutPass (Scout Clinical debit card), or check.
What else can you tell me?
Next steps
The study team is ready to answer any questions you have and will support you throughout your study participation. To find out if you are eligible, the team will schedule a 15 minutes phone call with you. You will be asked to provide information to make sure that you meet all the criteria to participate in the study.
If you are eligible
If you meet all the criteria for participating in the study, the study team will collect some additional information about you and your infant during an Enrollment call that can be scheduled after the Screening call.
You will be provided with paper forms to fill out throughout the study. There will be forms where you will note information about milk collections (date, time, how much collected) and there will be a anifrolumab administration form that you will take with you to your infusion appointment for the staff there to complete.
A nurse will visit your home to collect any blood samples. Milk samples will be picked up at your door throughout the study. You will need to store milk for a short time but someone from the study team will pack and ship the milk for you.
I would like to know more before I talk to someone from the study team
Day 1: Before Your First Infusion Appointment
On the day of your SAPHNELO™ (anifrolumab) treatment, immediately before going to your infusion appointment, you will be asked to pump and collect all milk from both breast and fill out the milk collection form. A home health nurse will also visit your home before your infusion appointment to collect the milk sample. During the same time the nurse will also take a small blood sample from you.
Day 2: Your First Infusion Appointment and After the Appointment
You will take the SAPHNELO™ (anifrolumab) administration form to the infusion appointment and ask the infusion staff to note the details of your infusion. After the appointment, you will be instructed to pump all the milk from both breasts every 4 hours for the next 24 hours. During this time you can feed your infant previously collected and stored milk from a bottle. The home health nurse will also visit your home to collect your blood sample up to 4 hours after your infusion appointment.
Day 3: After Your First Infusion Appointment
You will be instructed to pump and collect all the milk from both breasts approximately 2 days after your infusion appointment.
Days 4 to 29: After Your First Infusion Appointment
You will be asked to pump and collect all the milk from both breasts on days 4, 6, 8, 12, 16, 22, and 29 after your infusion appointment. The milk sample on day 29 will be collected before your next infusion appointment. Your blood sample will also be collected by the home health nurse on days 12 and 29 before your next infusion appointment.
Day 30: After Your Next Infusion Appointment
The home health nurse will visit your home to collect your infant’s blood sample after 24 hours of breastmilk feeding (i.e., breastfed or breastmilk in a bottle). Your infant’s blood will be taken from his/her heel.
There are no extra doctor´s office visits for this study. All your virtual visits will be done over the phone with the study staff.