Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
100

Inclusion Criterias

Documentation of gestational timing of the exposure to Stelara (ustekinumab) or Tremfya (guselkumab)
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)
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.

Exclusion Criterias

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.
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.

Summary

Conditions
  • Crohn Disease
  • Pregnancy
  • Psoriasis
  • Psoriatic Arthritis
Design
  • Observational Model: Case-Only
  • Time Perspective: Other

Participation Requirements

Age
Younger than 125 years
Gender
Only females

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 e...

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.

Inclusion Criterias

Documentation of gestational timing of the exposure to Stelara (ustekinumab) or Tremfya (guselkumab)
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)
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.

Exclusion Criterias

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.
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.

Locations

La Jolla, California, 92093
La Jolla, California, 92093

Tracking Information

NCT #
NCT02103361
Collaborators
  • The Organization of Teratology Information Specialists
  • Janssen Biotech, Inc.
Investigators
  • Principal Investigator: Christina Chambers, PhD, MPH University of California, San Diego
  • Christina Chambers, PhD, MPH University of California, San Diego