Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

Sponsor

University of California, San Diego (Other)

Overall Status

Recruiting

CT.gov ID

NCT02103361

Collaborator

The Organization of Teratology Information Specialists (Other), Janssen Biotech, Inc. (Industry)

200

Enrollment

Location

145

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Pregnancy Psoriatic Arthritis Crohn Disease	Drug: Ustekinumab Drug: Guselkumab

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Stelara (ustekinumab) exposed Stelara (ustekinumab)-exposed pregnant women	Drug: Ustekinumab Other Names: Stelara
Tremfya (guselkumab) exposed Tremfya (guselkumab-exposed pregnant women	Drug: Guselkumab Other Names: Tremfya

Arm

Intervention/Treatment

Stelara (ustekinumab) exposed

Stelara (ustekinumab)-exposed pregnant women

Drug: Ustekinumab

Other Names:

Stelara

Tremfya (guselkumab) exposed

Tremfya (guselkumab-exposed pregnant women

Drug: Guselkumab

Other Names:

Tremfya

Outcome Measures

Primary Outcome Measures

Major structural malformations [From 3 months prior to the first day of the last menstrual period and up to one year of age]
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.

Secondary Outcome Measures

Minor Congenital Structural Malformations [At dysmorphological exam which will occur at one time point between birth and one year of age]
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.

Other Outcome Measures

Spontaneous abortions [From 3 months prior to the first day of the last menstrual period until the day of delivery]
Rate of spontaneous abortions
Infant follow-up, growth [Birth to one year of age]
Pre- and post-natal fetal and infant growth, small for gestational age, and preterm delivery
Stillbirths [From 3 months prior to the first day of the last menstrual period until the day of delivery]
Rate of stillbirth
Infant follow-up, Immune system development [Birth to 1 year of age]
Health and development including effects to the immune system development.
Preterm delivery [Birth]
Rate of preterm delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	La Jolla	California	United States	92093

Sponsors and Collaborators

University of California, San Diego
The Organization of Teratology Information Specialists
Janssen Biotech, Inc.

Investigators

Principal Investigator: Christina Chambers, PhD, MPH, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Official research website of the Organization of Teratology Information Specialists, Studies coordinated at the University of California, San Diego

Publications

None provided.

Responsible Party:

Christina Chambers, Professor, Co-Director Center for Promotion of Maternal Health and Infant Development, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT02103361

Other Study ID Numbers:

CNTO1275PSO4037

First Posted:

Apr 3, 2014

Last Update Posted:

Apr 5, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Christina Chambers, Professor, Co-Director Center for Promotion of Maternal Health and Infant Development, University of California, San Diego