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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02103361
• Other study ID #: CNTO1275PSO4037
• Status: Recruiting
• Start date: November 2013
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: Diana Johnson, MS
• Phone: 877-311-8972
• Email: d4johnson[@]ucsd.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Autoimmune Diseases
• Crohn Disease
• Pregnancy
• Psoriasis
• Psoriatic Arthritis

Intervention

Drug:
• Ustekinumab

• Guselkumab

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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