Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases
Launched by IRCCS SAN RAFFAELE · Dec 10, 2019
Trial Information
Current as of November 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring the safety of using biologic medications during pregnancy for mothers with autoimmune diseases, which are conditions where the body's immune system attacks its own cells. The study aims to understand how these medications might affect the babies born to these mothers, both right after birth and in the long term. By demonstrating that these treatments are safe for newborns, the research could help more women with autoimmune diseases access effective care during their pregnancies.
To participate in this study, children who were born to mothers treated with biologic agents are eligible. There are no specific exclusions mentioned, making it easier for families to consider joining. If you decide to participate, you and your child will help researchers gather important information that could benefit many future pregnancies. Overall, this study is crucial for understanding the impacts of these medications on newborns and ensuring safe treatment options for mothers and their children.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • children born from mothers treated with biologic agents
- Exclusion Criteria:
- • -
About Irccs San Raffaele
IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, Lombardia, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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