Ankylosing Spondylitis, Crohn's Disease, Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Autoimmune disease, certolizumab pegol, Cimzia, pregnancy, birth defect, birth outcome, TNF, Tumor necrosis factor
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 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.
Detailed description
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.
Interventions
None listed
Sponsors
The Organization of Teratology Information Specialists
UCB Pharma
University of California, San Diego
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 | Duration of 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minor malformations | At dysmorphological exam which will occur at one time point between birth and 5 years 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. |
| Pregnancy Outcome | Duration of pregnancy and up to 1 year of life | Another 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 |
| Infant follow-up | Duration of pregnancy and up to 5 years of life | Pre- and post-natal fetal and infant growth, health and development |
Countries
United States
Outcome results
None listed