Clinical trial NCT04197232: Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases
Official title: Study on the Safety for the Newborn of the Use of Biologics During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Suspected Damage to Fetus From Biologic Agents
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children born from mothers treated with biologic agents during pregnancy

Brief summary: 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.

Detailed description: Biologic agents are a group of genetically engineered drugs that target the immune system and have gained a lot of popularity in recent years. They act by interfering with cytokine function or production, inhibiting the "second signal" required for T-cell activation or by depleting B-cells. They are used for the treatment of a wide variety of diseases including Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus (SLE), some types of vasculitis and many more. Many of these pathologies occur in young women during child-bearing years and so it is important for these drugs to not only be safe to use for the patient but also during pregnancy for fetus and child. Many studies are conducted on their safety for the patients but few studies are present on the safety of use during pregnancy. There are even fewer studies that follow up for long term effects on the children outside of the perinatal period.

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.

Eligibility criteria: Inclusion Criteria:

* children born from mothers treated with biologic agents

Exclusion Criteria:

-

Primary outcomes:
measure: Safety on fetus of biologic agents used during pregnancy
timeFrame: 8 years
measure: Safety on fetus of biologic agents used during pregnancy - fetal development
timeFrame: 8 years
measure: Safety on fetus of biologic agents used during pregnancy - adequate growth for GA
timeFrame: 8 years
measure: Safety on fetus of biologic agents used during pregnancy - perinatal complications
timeFrame: 8 years
measure: Safety on fetus of biologic agents used during pregnancy - neurological development
timeFrame: 8 years
measure: Safety on fetus of biologic agents used during pregnancy - immunological evaluation
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS ospedale san raffaele
state: Lombardia
Study officials:
References: