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Trial record 1 of 1 for:    NCT03031938
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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

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date August 18, 2020
Actual Study Start Date  ICMJE November 3, 2017
Actual Primary Completion Date June 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • 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
  • 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
  • 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
  • Change in Bayley Infant Neurodevelopmental Screener (BINS) [ Time Frame: 8 months, 15 months, unscheduled visits up to 36 month ]
  • Change in Bzoch-League Receptive Expressive Emergent Language Test (REEL-3) [ Time Frame: 8 months, 15 months, unscheduled visits up to 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
Official Title  ICMJE 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
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.
Detailed Description A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Osteoarthritis
  • Cancer Pain
  • Recurrent Low Back Pain
Intervention  ICMJE 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
Study Arms  ICMJE Cohort 1
Long term observational study of subjects from tanezumab parent study
Intervention: Drug: Investigational medical product (IMP) administered in parent study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2019)
4
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
10
Actual Study Completion Date  ICMJE June 4, 2020
Actual Primary Completion Date June 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031938
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP