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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Pregnancy; Crohn Disease; Psoriatic Arthritis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Diana Johnson, MS; Phone Number: 877-311-8972; Email: d4johnson@ucsd.edu
• Study Contact Backup: Name: Christina Chambers, PhD, MPH; Phone Number: 877-311-8972; Email: chchambers@ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California, San Diego
      • Contact: Johnson
      • Principal Investigator: Christina Chambers, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women who have had exposure to Stelara (ustekinumab) or Tremfya (guselkumab) within 3 months of the last menstrual period, or anytime during pregnancy, and who reside in the U.S. or Canada.

The Stelara (ustekinumab) exposed group completed enrollment as of September 2019. The Tremfya (guselkumab) remains open to recruitment.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tremfya (guselkumab) exposed; Tremfya (guselkumab-exposed pregnant women	Drug: Guselkumab; Other Names: Tremfya
Stelara (ustekinumab) exposed; Stelara (ustekinumab)-exposed pregnant women (this group is now closed to recruitment)	Drug: Ustekinumab; Other Names: Stelara

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous abortions	Rate of spontaneous abortions	From 3 months prior to the first day of the last menstrual period until the day of delivery
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
Stillbirths	Rate of stillbirth	From 3 months prior to the first day of the last menstrual period until the day of delivery
Infant follow-up, Immune system development	Health and development including effects to the immune system development.	Birth to 1 year of age
Preterm delivery	Rate of preterm delivery	Birth

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Janssen Biotech, Inc.; The Organization of Teratology Information Specialists
• Investigators: Principal Investigator: Christina Chambers, PhD, MPH, University of California, San Diego

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 3, 2014

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; Crohn's Disease; psoriatic arthritis; psoriasis; autoimmune disease; Stelara; Tremfya; ustekinumab; guselkumab; birth outcome; malformation; birth defect
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Immune System Diseases; Gastrointestinal Diseases; Joint Diseases; Musculoskeletal Diseases; Gastroenteritis; Intestinal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Inflammatory Bowel Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Crohn Disease; Arthritis, Psoriatic; Autoimmune Diseases; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: CNTO1275PSO4037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No