OTIS Autoimmune Diseases in Pregnancy Project

Study Overview
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Brief Summary
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The purpose of the OTIS Autoimmune disease 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 one year 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 that 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.

Official Title
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Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project

Conditions
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Crohn's Disease, Rheumatoid 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 - Exposure cohort<br>Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have used adalimumab in the first trimester of pregnancy for any length of time from the date of conception. | |
| Cohort 2 - Matched Diseased Comparison Cohort<br>Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have not used adalimumab or any TNF antagonist in pregnancy. | |
| Cohort 3-Non-Diseased Comparison Cohort<br>Pregnant women without a current diagnosis of an autoimmune disease and who have not used adalimumab or any TNF antagonist at any time in pregnancy nor have they been exposed to any known human teratogen during pregnancy. | |
| Cohort 4 - Registry Group<br>Pregnant women who have used adalimumab for any length of time following the first day of the last menstrual period until the end of pregnancy who do not meet Cohort 1 inclusionary criteria. | |

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 of newborns. | Throughout 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 | 
| Pregnancy outcome | Another objective of the study is to evaluate the effects of certain medications when used during pregnancy with respect to spontaneous abortion, stillbirth, and preterm delivery. | Throughout pregnancy | 
| Infant follow-up | Pre- and post-natal fetal and infant growth, health and development | Throughout pregnancy and up to 1 year of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autoimmune diseases, adalimumab, pregnancy, birth defects, TNF, Tumor necrosis factor