OTIS Autoimmune Diseases in Pregnancy Project
The purpose of the OTIS Autoimmune disease 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 that 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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project|
- Major malformations [ Time Frame: Throughout pregnancy and up to 1 year of life ] [ Designated as safety issue: Yes ]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 of newborns.
- Minor malformations [ Time Frame: At dysmorphological exam ] [ Designated as safety issue: Yes ]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.
- Pregnancy outcome [ Time Frame: Throughout pregnancy ] [ Designated as safety issue: Yes ]Another objective of the study is to evaluate the effects of certain medications when used during pregnancy with respect to spontaneous abortion, stillbirth, and preterm delivery.
- Infant follow-up [ Time Frame: Throughout pregnancy and up to 1 year of life ] [ Designated as safety issue: Yes ]Pre- and post-natal fetal and infant growth, health and development
|Study Start Date:||November 2003|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Cohort 1 - Exposure cohort
Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have used adalimumab in the first trimester of pregnancy for any length of time from the date of conception.
Cohort 2 - Matched Diseased Comparison Cohort
Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have not used adalimumab or any TNF antagonist in pregnancy.
Cohort 3-Non-Diseased Comparison Cohort
Pregnant women without a current diagnosis of an autoimmune disease and who have not used adalimumab or any TNF antagonist at any time in pregnancy nor have they been exposed to any known human teratogen during pregnancy.
Cohort 4 - Registry Group
Pregnant women who have used adalimumab for any length of time following the first day of the last menstrual period until the end of pregnancy who do not meet Cohort 1 inclusionary criteria.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086059
|Contact: Diana Johnson, MSfirstname.lastname@example.org|
|Contact: Christina Chambers, PhD, MPHemail@example.com|
|United States, California|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States, 92093-0828|
|Principal Investigator: Kenneth L Jones, MD|
|Principal Investigator:||Kenneth L Jones, MD||University of California, San Diego|