Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031938
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : August 18, 2020
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Cancer Pain Recurrent Low Back Pain Drug: Investigational medical product (IMP) administered in parent study Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : November 3, 2017
Actual Primary Completion Date : June 4, 2020
Actual Study Completion Date : June 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cohort 1
Long term observational study of subjects from tanezumab parent study
Drug: Investigational medical product (IMP) administered in parent study
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study




Primary Outcome Measures :
  1. Change in Physical measures [ Time Frame: 0-2 months, 8 months, 15 months and unscheduled visits up to 36 months ]
    Occipital-frontal head circumference, length, weight

  2. Change in Vital Signs [ Time Frame: 0-2 months, 8 months, 15 months, unscheduled visits up to 36 months ]
    Blood pressure, pulse rate, respiratory rate, temperature

  3. Change in Neurological measures [ Time Frame: 0-2 months, 8 months, 15 months, unscheduled visits up to 36 months ]
    Mental status, cranial nerves, motor and sensory systems, reflexes

  4. Change in Bayley Infant Neurodevelopmental Screener (BINS) [ Time Frame: 8 months, 15 months, unscheduled visits up to 36 month ]
  5. Change in Bzoch-League Receptive Expressive Emergent Language Test (REEL-3) [ Time Frame: 8 months, 15 months, unscheduled visits up to 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031938


Locations
Layout table for location information
United States, California
USC Keck School of Medicine
Los Angeles, California, United States, 90033
United States, Florida
Gulfcoast Research Institute
Sarasota, Florida, United States, 34232
Kennedy and White Orthopaedic Center
Sarasota, Florida, United States, 34232
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, United States, 33609
United States, Indiana
Lafayette Clinical Research Group
Lafayette, Indiana, United States, 47905
Preferred Pediatrics
Lafayette, Indiana, United States, 47905
Sponsors and Collaborators
Pfizer
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03031938    
Other Study ID Numbers: A4091065
2013-002548-10 ( EudraCT Number )
INFANT SAFETY FOLLOW-UP #2 ( Other Identifier: Alias Study Number )
NEONATAL MONITORING STUDY #2 ( Other Identifier: Alias Study Number )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Exposure in utero in tanezumab program
Additional relevant MeSH terms:
Layout table for MeSH terms
Low Back Pain
Cancer Pain
Back Pain
Pain
Neurologic Manifestations