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NCT Number: NCT02103361

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.

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Key information

Conditions

Psoriasis Arthritis Arthritis, Psoriatic Autoimmune Diseases Bone Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Pregnancy Psoriatic Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Christina Chambers, PhD, MPH

PRINCIPAL_INVESTIGATOR

Johnson

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ustekinumab

Drug

Other names: Stelara

Guselkumab

Drug

Other names: Tremfya

Primary outcomes

  1. Major structural malformations

    Time frame: 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 outcomes

  1. Minor Congenital Structural Malformations

    Time frame: 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 outcomes

  1. Spontaneous abortions

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

    Rate of spontaneous abortions

  2. Infant follow-up, growth

    Time frame: Birth to one year of age

    Pre- and post-natal fetal and infant growth, small for gestational age, and preterm delivery

  3. Stillbirths

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

    Rate of stillbirth

  4. Infant follow-up, Immune system development

    Time frame: Birth to 1 year of age

    Health and development including effects to the immune system development.

  5. Preterm delivery

    Time frame: Birth

    Rate of preterm delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Chambers, PhD, MPH

CONTACT

[email protected]

877-311-8972

Diana Johnson, MS

CONTACT

[email protected]

877-311-8972

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Janssen Biotech, Inc.
  • The Organization of Teratology Information Specialists

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2030
Study completion
2031
First posted
Apr 3, 2014
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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