Crohn Disease, Pregnancy, Psoriasis, Psoriatic Arthritis
Conditions
Keywords
autoimmune disease, pregnancy, psoriasis, Stelara, ustekinumab, birth outcome, malformation, birth defect, psoriatic arthritis, Crohn's Disease, Tremfya, guselkumab
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.
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.
Interventions
DRUGUstekinumab
DRUGGuselkumab
Sponsors
The Organization of Teratology Information Specialists
Janssen Biotech, Inc.
University of California, San Diego
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major structural malformations | 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
| Measure | Time frame | Description |
|---|---|---|
| Minor Congenital Structural Malformations | 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
| Measure | Time frame | Description |
|---|---|---|
| Stillbirths | From 3 months prior to the first day of the last menstrual period until the day of delivery | Rate of stillbirth |
| Spontaneous abortions | From 3 months prior to the first day of the last menstrual period until the day of delivery | Rate of spontaneous abortions |
| Preterm delivery | Birth | Rate of preterm delivery |
| Infant follow-up, Immune system development | Birth to 1 year of age | Health and development including effects to the immune system development. |
| Infant follow-up, growth | Birth to one year of age | Pre- and post-natal fetal and infant growth, small for gestational age, and preterm delivery |
Countries
United States
Contacts
Primary ContactDiana Johnson, MS
Backup ContactChristina Chambers, PhD, MPH
Outcome results
None listed