Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases

Recruiting now

Conditions studied: Suspected Damage to Fetus From Biologic Agents

In brief

The goal of the study is to evaluate the effects on the offspring and therefore the safety of using biologic agents during pregnancy and their eventual consequences on children. The effects considered are divided into peri-partum and more long-term effects. Demonstration of safety in children born from mothers who received biologics during pregnancy will pave the way of their use in other women affected by autoimmune diseases unresponsive to standard treatment.

Key facts

Study ID

NCT04197232

Run by

IRCCS San Raffaele

People needed

50

Starts

2018-08-31

Expected to finish

2026-08-31

Last updated by the study team

2019-12-13

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• children born from mothers treated with biologic agents

Where it is running

• IRCCS ospedale san raffaele — Milan, Lombardy, Italy (enrolling)

Full record on ClinicalTrials.gov

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