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

• Status: Completed
• Trial end date: 2020-06-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: Eli Lilly and Company

Criteria

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.