OTIS Autoimmune Diseases in Pregnancy Project

Study Overview
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Brief Summary
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The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for five years after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

Detailed Description
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The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Cimzia Pregnancy Exposure Registry is to follow pregnant women with or without a Cimzia approved indication who have or have not been treated with Cimzia during pregnancy to evaluate the possible effect of these diseases, and or this medication on the pregnancy outcome including child development and growth up to five years of age.

Official Title
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Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project

Conditions
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Psoriasis, Crohn's Disease, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently pregnant
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 - Exposed Cohort<br>Pregnant women with a current diagnosis of an approved indication who have used Cimzia (certolizumab pegol) in the first trimester of pregnancy for any length of time from the date of conception. | |
| Cohort 2 - Diseased Comparison Cohort<br>Pregnant women with a current diagnosis of a Cimzia approved indication who have not used Cimzia (certolizumab pegol) during the current pregnancy. | |
| Cohort 3 - Non-Diseased Comparison Cohort<br>Pregnant women without a current diagnosis of an autoimmune disease and who have not used Cimzia (certolizumab pegol) at any time in pregnancy, nor have they been exposed to any known human teratogen during pregnancy. | |
| Group 4 -Cimzia Registry, Not Qualified for the Cohort Study<br>Women who have used Cimzia (certolizumab pegol) for any length of time following the first day of the last menstrual period until the end of pregnancy who do not qualify for the prospective cohort study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major malformations | The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects. | Duration of pregnancy and up to 1 year of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor malformations | One secondary objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to potential minor malformations. | At dysmorphological exam which will occur at one time point between birth and 5 years of age | 
| Pregnancy Outcome | Another objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to potential minor malformations | Duration of pregnancy and up to 1 year of life | 
| Infant follow-up | Pre- and post-natal fetal and infant growth, health and development | Duration of pregnancy and up to 5 years of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autoimmune disease, certolizumab pegol, Cimzia, pregnancy, birth defect, birth outcome, TNF, Tumor necrosis factor