RECRUITING

Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users

Conditions

Systemic Lupus Erythematosus Chronic autoimmune disease Immunosuppressants Corticosteroids Human monoclonal antibody (IgG1ƙ mAb)Post Marketing Requirements (PMR) study

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 receive anifrolumab therapeutically.

Official Title

PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab

Quick Facts

Study Start:2024-11-29

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06594068

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 130 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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, at least 3 consecutive previous doses during the post-partum period) with anifrolumab by the time of study Day 1 (pre-dose milk collection)1 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 1. Gestational age at delivery ≥32 weeks 2. Birthweight \> 10th percentile 3. Weight \> 10th percentile at the time of enrollment	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 months5 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) 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

Inclusion Criteria

Exclusion Criteria

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, at least 3 consecutive previous doses during the post-partum period) with anifrolumab by the time of study Day 1 (pre-dose milk collection)1
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
1. Gestational age at delivery ≥32 weeks
2. Birthweight \> 10th percentile
3. Weight \> 10th percentile at the time of enrollment

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 months5
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)
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

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Principal Investigator

Darin Brimhall, MD

PRINCIPAL_INVESTIGATOR

PPD, Las Vegas, US

Study Locations (Sites)

Research Site

Las Vegas, Nevada, 89113

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Darin Brimhall, MD, PRINCIPAL_INVESTIGATOR, PPD, Las Vegas, US

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-29

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2024-11-29

Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

Chronic autoimmune disease
Immunosuppressants
Corticosteroids
Human monoclonal antibody (IgG1ƙ mAb)
Post Marketing Requirements (PMR) study

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus