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

Suspected Damage to Fetus From Biologic Agents Clinical Trial

— BIOGN1  

Official title:

Study on the Safety for the Newborn of the Use of Biologics During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197232
• Other study ID #: BIOGN1
• Status: Recruiting
• Start date: August 31, 2018
• Est. completion date: August 31, 2026

Study information

• Verified date: December 2019
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2018
• Gender: All
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• children born from mothers treated with biologic agents

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Suspected Damage to Fetus From Biologic Agents

Intervention

Other:
• clinical evaluation
- In children: general clinical evaluation, birth weight, APGAR, ECG, admission to ICU, hospital admissions in perinatal age, presence of malformations; complete blood count, inflammatory index, complement, antibiotic treatment, brain ultra-sound, presence of infection, presence of sepsis, presence of necrotizing enterocolitis, growth curve, presence of recurrent infections, developmental milestones, response to vaccines, admission to hospital in the first year of life.

Locations

Country	Name	City	State
Italy	IRCCS ospedale san raffaele	Milan	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety on fetus of biologic agents used during pregnancy	Evaluation of increased incidence of preterm births (measured by gestational age at birth (gestational weeks)	8 years
Primary	Safety on fetus of biologic agents used during pregnancy - fetal development	Evaluation of normal intrauterine development (measured by presence of Intra-Uterine Growth Restriction, presence of malformations (number#), birth weight (grams), length (cm), head circumference (cm))	8 years
Primary	Safety on fetus of biologic agents used during pregnancy - adequate growth for GA	Evaluation of normal intrauterine development - birth weight (grams), length (cm), head circumference (cm))	8 years
Primary	Safety on fetus of biologic agents used during pregnancy - perinatal complications	Evaluation of increased rate of perinatal complications (measured by: admission to ICU (number#), hospital admissions in perinatal) (number#)	8 years
Primary	Safety on fetus of biologic agents used during pregnancy - neurological development	Evaluation of developmental milestones (age in months of acquisition of head control, sitting position, crawling and standing position)	8 years
Primary	Safety on fetus of biologic agents used during pregnancy - immunological evaluation	Evaluation of immunological status (complete blood count (absolute counts od WBC, Lymphocytes and Neutrophilis), presence of infection (number #), response to vaccines (presence/absence)	8 years