OTIS Autoimmune Diseases in Pregnancy Project
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01086059|
Recruitment Status : Active, not recruiting
First Posted : March 12, 2010
Last Update Posted : March 24, 2017
|Condition or disease|
|Crohn's Disease Rheumatoid Arthritis|
|Study Type :||Observational|
|Estimated Enrollment :||554 participants|
|Official Title:||Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||April 2017|
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.
- Major malformations [ Time Frame: Throughout pregnancy and up to 1 year of life ]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 ]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 ]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 ]Pre- and post-natal fetal and infant growth, health and development
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086059
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093-0828|
|Principal Investigator:||Kenneth L Jones, MD||University of California, San Diego|