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Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project


N/A
N/A
N/A
Open (Enrolling)
Female
Crohn's Disease, Rheumatoid Arthritis

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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 DiegoLa Jolla, California  92037-1709