Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project

This pregnancy registry cohort study will be conducted by the Organization of Teratology
Information Specialists (OTIS) which is a network of university and health department based
telephone information centers serving pregnant women and health care providers throughout
North America.

Participants in the first two cohorts are recruited concurrently from callers to OTIS
centers, from health care providers and through direct to consumer marketing efforts. The
source of historical controls is archived data on pregnancies that have been followed
through the California Teratogen Information Service's Clinical Research Program located at
the University of California San Diego.

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
RA, JRA, AS, PsoA or 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 RA, JRA, AS, PsoA or PsO and had not been
exposed to a known human teratogen during the index pregnancy.