OTIS Humira Pregnancy Registry

Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01086059

Enrollment

944

Registered

2010-03-12

Start date

2003-11-30

Completion date

2019-10-31

Last updated

2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Rheumatoid Arthritis

Keywords

Autoimmune diseases, adalimumab, pregnancy, birth defects, TNF, Tumor necrosis factor

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* Currently pregnant

Design outcomes

Primary

Measure	Time frame	Description
Major malformations	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.

Secondary

Measure	Time frame	Description
Minor malformations	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	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	Throughout pregnancy and up to 1 year of life	Pre- and post-natal fetal and infant growth, health and development

Countries

United States

Outcome results