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

NCT02103361 | Recruiting FDA Drug

• 1 other identifier: CNTO1275PSO4037
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Pregnancy; Psoriatic Arthritis; Crohn Disease

Keywords

autoimmune disease; pregnancy; psoriasis; Stelara; ustekinumab; birth outcome; malformation; birth defect; psoriatic arthritis; Crohn's Disease; Tremfya; guselkumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Minor Congenital Structural Malformations

  At dysmorphological exam which will occur at one time point between birth and one year of age

Other Outcomes (5)

• Spontaneous abortions

  From 3 months prior to the first day of the last menstrual period until the day of delivery

• Infant follow-up, growth

  Birth to one year of age

• Stillbirths

  From 3 months prior to the first day of the last menstrual period until the day of delivery

Study Arms (2)

Stelara (ustekinumab) exposed

Stelara (ustekinumab)-exposed pregnant women (this group is now closed to recruitment)

Drug: Ustekinumab

Tremfya (guselkumab) exposed

Tremfya (guselkumab-exposed pregnant women

Drug: Guselkumab

Interventions

Ustekinumab DRUG

Also known as: Stelara

Stelara (ustekinumab) exposed

Guselkumab DRUG

Also known as: Tremfya

Tremfya (guselkumab) exposed

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• The Organization of Teratology Information Specialists: collaborator
• Janssen Biotech, Inc.: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic; Crohn Disease; Autoimmune Diseases; Congenital Abnormalities

Interventions

Ustekinumab; guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Immune System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Christina Chambers, PhD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Johnson, MS

CONTACT

877-311-8972; d4johnson@ucsd.edu

Christina Chambers, PhD, MPH

CONTACT

877-311-8972; chchambers@ucsd.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Co-Director Center for Promotion of Maternal Health and Infant Development

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: April 3, 2014
• Study Start: November 1, 2013
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): February 1, 2031
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

US (1)