OTIS Autoimmune Diseases in Pregnancy Project
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Psoriasis, Rheumatoid Arthritis, Infectious Disease, Neurology, Neurology, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology, Immunology / Infectious Diseases, Neurology, Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2012 |
| End Date: | December 2022 |
| Contact: | Diana Johnson, MS |
| Email: | d4johnson@ucsd.edu |
| Phone: | 877-311-8972 |
Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
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 five years 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.
unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic
effect of these medications and to follow live born infants for five years 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.
The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Cimzia Pregnancy Exposure
Registry is to follow pregnant women with or without a Cimzia approved indication who have
or have not been treated with Cimzia during pregnancy to evaluate the possible effect of
these diseases, and or this medication on the pregnancy outcome including child development
and growth up to five years of age.
Registry is to follow pregnant women with or without a Cimzia approved indication who have
or have not been treated with Cimzia during pregnancy to evaluate the possible effect of
these diseases, and or this medication on the pregnancy outcome including child development
and growth up to five years of age.
Inclusion Criteria:
- Currently pregnant
We found this trial at
1
site
San Diego, California 92093
Principal Investigator: Christina Chambers, MPH, PhD
Phone: 877-311-8972
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