Suspected Damage to Fetus From Biologic AgentsBIOGN1NCT04197232
Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases
An observational study of Suspected Damage to Fetus From Biologic Agents, run by IRCCS San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 day to 12 years
- Conditions the study is for
- Suspected Damage to Fetus From Biologic Agents
- What is being tested?
- clinical evaluation
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 31 Aug 2018to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 years
- All sexes
- Child
Study population: children born from mothers treated with biologic agents during pregnancy
Who may be able to join
- children born from mothers treated with biologic agents
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS ospedale san raffaele
Milan, Lombardy, 20132
rosanna rovelli, 0226436074, rovelli.rosanna@hsr.it
laura lorioli, 0226436074, lorioli.laura@hsr.it
About this study
Official title: 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.
Read the 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.
- Being tested
- clinical evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical evaluationOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety on fetus of biologic agents used during pregnancy
Evaluation of increased incidence of preterm births (measured by gestational age at birth (gestational weeks)
Measured: 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))
Measured: 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))
Measured: 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#)
Measured: 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)
Measured: 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)
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start31 Aug 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Damage to Fetus From Biologic AgentsStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosanna Rovelli, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197232
- Sponsor's protocol ID
- BIOGN1
- Acronym
- BIOGN1
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety for the Newborn of the Use of Biologics During Pregnancy
- ClinicalTrials.gov ID
- NCT04197232
- Acronym / sponsor ID
- BIOGN1 / BIOGN1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: clinical evaluationThe 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. |
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- children born from mothers treated with biologic agents during pregnancy
Key inclusion criteria (1 listed)
- children born from mothers treated with biologic agents
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | not exposed |
Primary outcome
Safety on fetus of biologic agents used during pregnancy
Time frame: 8 years
Evaluation of increased incidence of preterm births (measured by gestational age at birth (gestational weeks)
Safety on fetus of biologic agents used during pregnancy - fetal development
Time frame: 8 years
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))
Safety on fetus of biologic agents used during pregnancy - adequate growth for GA
Time frame: 8 years
Evaluation of normal intrauterine development - birth weight (grams), length (cm), head circumference (cm))
Safety on fetus of biologic agents used during pregnancy - perinatal complications
Time frame: 8 years
Evaluation of increased rate of perinatal complications (measured by: admission to ICU (number#), hospital admissions in perinatal) (number#)
Safety on fetus of biologic agents used during pregnancy - neurological development
Time frame: 8 years
Evaluation of developmental milestones (age in months of acquisition of head control, sitting position, crawling and standing position)
Safety on fetus of biologic agents used during pregnancy - immunological evaluation
Time frame: 8 years
Evaluation of immunological status (complete blood count (absolute counts od WBC, Lymphocytes and Neutrophilis), presence of infection (number #), response to vaccines (presence/absence)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suspected Damage to Fetus From Biologic Agents, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety on fetus of biologic agents used during pregnancy (time frame: 8 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.