Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases (BIOGN1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Suspected Damage to Fetus From Biologic Agents
• Intervention / Treatment: Other: clinical evaluation

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Milan, Lombardia, Italy, 20132
      • Recruiting
      • IRCCS Ospedale San Raffaele
      • Contact: rosanna rovelli; Phone Number: 0226436074; Email: rovelli.rosanna@hsr.it
      • Contact: laura lorioli; Phone Number: 0226436074; Email: lorioli.laura@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 12 years (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children born from mothers treated with biologic agents during pregnancy

Description

Inclusion Criteria:

• children born from mothers treated with biologic agents

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
exposed; The modality of study is a cohort study that evaluates the performance of children exposed to biologic agents during pregnancy compared to the performance of children born at the same gestational age not exposed to biologic agents.
not exposed; The modality of study is a cohort study that evaluates the performance of children exposed to biologic agents during pregnancy compared to the performance of children born at the same gestational age not exposed to biologic agents.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2018
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ANTICIPATED): August 31, 2026

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: BIOGN1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No