Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies

Status:	Recruiting
Conditions:	Arthritis, Back Pain, Back Pain, Osteoarthritis (OA)
Therapuetic Areas:	Musculoskeletal, Rheumatology
Healthy:	No
Age Range:	Any
Updated:	12/6/2018
Start Date:	November 3, 2017
End Date:	April 4, 2022
Contact:	Pfizer CT.gov Call Center
Email:	ClinicalTrials.gov_Inquiries@pfizer.com
Phone:	1-800-718-1021

A Protocol To Monitor From Birth To Age 15 Months The Neurological Development Of Infants With Exposure In-utero In Tanezumab Clinical Studies At All Investigational Sites

A4091065 is a multicenter, prospective, cohort study with enhance physical an
neurodevelopmental surveillance to characterize the outcomes related to the development of
infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or
comparator via maternal exposure or in utero in any tanezumb study.

A4091065 is a long term observational follow up study of subjects from tanezumab
interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063

Inclusion Criteria:

- Subject is an infant born to a mother who was exposed to study drug on a tanezumab
clinical study.

- The infant's mother (who was the tanezumab clinical study participant) must review,
agree and sign an informed consent document explaining the details of the perinatal
and post natal follow up. Where local regulations mandate, the male parent would also
review and sign the informed consent.

- Parents or legal guardian must be willing and able to comply with scheduled visits and
study procedures.

Exclusion Criteria:

- There are no exclusion criteria for participating in this study.

We found this trial at

sites

Gulfcoast Research Institute, LLC

Sarasota, Florida 34232

from

Sarasota, FL