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OTIS Autoimmune Diseases in Pregnancy Project


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N/A
N/A
Open (Enrolling)
Female
Pregnancy

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Trial Information

OTIS Autoimmune Diseases in Pregnancy Project


Cohort 1

Inclusion Criteria:

Eligible subjects will be currently pregnant women residing
in the US or Canada who have had any exposure to etanercept for treatment of Rheumatoid
Arthritis (RA), Juvenile RA, Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsoA) or
Psoriasis (PsO) at any time during the first trimester of pregnancy which is defined as
the period between first day of the last menstrual period (i.e., within two weeks of
conception) up to and including the 12th week after the first day of the last menstrual
period (LMP) - Eligible subjects must have documentation of an exposure to etanercept
during the first trimester of pregnancy

Cohort 2

Inclusion Criteria:

Eligible subjects will be currently pregnant women residing
in the US or Canada who have not taken etanercept or any TNF antagonist for treatment of
Rheumatoid Arthritis (RA), Juvenile RA, Ankylosing Spondylitis (AS), Psoriatic Arthritis
(PsoA) or Psoriasis (PsO) at any time in the current pregnancy or within two months prior
to the first day of the last menstrual period (LMP)

Cohort 3

Inclusion Criteria:

Eligible subjects will be pregnant women who were residing in
the US or Canada who had not been diagnosed with Rheumatoid Arthritis (RA), Juvenile RA,
Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsoA) or Psoriasis (PsO) and had not
been exposed to a known human teratogen during the index pregnancy

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

Compare the incidence rates (birth prevalence) of major birth defects

Outcome Time Frame:

8 years

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20040246

NCT ID:

NCT00116272

Start Date:

March 2005

Completion Date:

March 2014

Related Keywords:

  • Pregnancy
  • pregnancy
  • Autoimmune Disease
  • Autoimmune Diseases

Name

Location

Research SiteAnaheim, California