Stelara and Tremfya Pregnancy Exposure Registry 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 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 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 Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project is to follow pregnant women or women who have delivered a baby, who have been treated with Stelara or Tremfya within 3 months of their last menstrual period (LMP) or during pregnancy to evaluate the possible effect of this medication on the pregnancy outcome including child development and growth up to one year of age.

Official Title
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Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project

Conditions
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Psoriasis, Pregnancy, Psoriatic Arthritis, Crohn Disease

Intervention / Treatment
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* Drug: Ustekinumab
* Drug: Guselkumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documentation of an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months prior to the first day of the last menstrual period (LMP) for any number of days, at any time, at any dose, and at any time until completion of pregnancy. Documentation of gestational timing of the exposure to Stelara (ustekinumab) or Tremfya (guselkumab) Exclusion Criteria: Women who have not have an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months of the first day of the last menstrual period.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stelara (ustekinumab) exposed<br>Stelara (ustekinumab)-exposed pregnant women (this group is now closed to recruitment) | Drug: Ustekinumab<br> <br> * Other names: Stelara;|
| Tremfya (guselkumab) exposed<br>Tremfya (guselkumab-exposed pregnant women | Drug: Guselkumab<br> <br> * Other names: Tremfya;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major structural 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. | From 3 months prior to the first day of the last menstrual period and up to one year of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor Congenital Structural 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 one year of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autoimmune disease, pregnancy, psoriasis, Stelara, ustekinumab, birth outcome, malformation, birth defect, psoriatic arthritis, Crohn's Disease, Tremfya, guselkumab