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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Cancer Pain

Osteoarthritis

Recurrent Low Back Pain

Treatments

Drug: Investigational medical product (IMP) administered in parent study

Study type

Interventional

Funder types

Industry

Identifiers

NCT03031938

A4091065

INFANT SAFETY FOLLOW-UP #2 (Other Identifier)

2013-002548-10 (EudraCT Number)

NEONATAL MONITORING STUDY #2 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment

4 patients

Sex

All

Ages

Under 2 months old

Volunteers

No Healthy Volunteers

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