Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
N/A
N/A
Female
Crohn's Disease, Rheumatoid Arthritis
Trial Information
Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Cimzia Pregnancy Exposure
Registry is to follow pregnant women with or without rheumatoid arthritis (RA) or Crohn's
Disease (CD) 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Major malformations
Outcome Description:
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.
Outcome Time Frame:
Duration of pregnancy and up to 1 year of life
Safety Issue:
Yes
Principal Investigator
Christina Chambers, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Diego
Authority:
United States: Institutional Review Board
Study ID:
RA0023
NCT ID:
NCT01797224
Start Date:
March 2012
Completion Date:
December 2022
Related Keywords:
- Crohn's Disease
- Rheumatoid Arthritis
- Autoimmune disease
- certolizumab pegol
- Cimzia
- pregnancy
- birth defect
- birth outcome
- TNF
- Tumor necrosis factor
- Arthritis
- Arthritis, Rheumatoid
- Autoimmune Diseases
- Crohn Disease
Name | Location |
|---|---|
| University of California, San Diego | La Jolla, California 92037-1709 |
