Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT04197232
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.
Study:
NCT04197232
Study Brief:
Protocol Section:
NCT04197232