Clinical trial NCT03031938: Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Cancer Pain
Recurrent Low Back Pain
Keywords: Exposure in utero in tanezumab program
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2017-01-26
Enrollment: 4
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility 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.

Primary outcomes:
measure: Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 2 Months
measure: Occipital-frontal Head Circumference at 8 Months of Participant's Age
timeFrame: At 8 Months of participants' age
measure: Occipital-frontal Head Circumference at 15 Months of Participant's Age
timeFrame: At 15 Months of participants' age
measure: Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 3 Months
measure: Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age
timeFrame: Any visit during participants' age above 3 Months and up to 6 Months
measure: Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age
timeFrame: Any visit during participants' age above 6 Months and up to 9 Months
measure: Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age
timeFrame: Any visit during participants' age above 15 Months and up to 18 Months
measure: Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age
timeFrame: Any visit during participants' age above 21 Months and up to 24 Months
measure: Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age
timeFrame: Any visit during participants' age above 24 Months and up to 30 Months
measure: Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 2 Months
measure: Body Length at 8 Months of Participant's Age
timeFrame: At 8 Months of participant's age
measure: Body Length at 15 Months of Participant's Age
timeFrame: At 15 Months of participant's age
measure: Body Length During 0 to <=3 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 3 Months
measure: Body Length During >3 to <=6 Months of Participant's Age
timeFrame: Any visit during participants' age above 3 Months and up to 6 Months
measure: Body Length During >6 to <=9 Months of Participant's Age
timeFrame: Any visit during participants' age above 6 Months and up to 9 Months
measure: Body Length During >15 to <=18 Months of Participant's Age
timeFrame: Any visit during participants' age above 15 Months and up to 18 Months
measure: Body Length During >21 to <=24 Months of Participant's Age
timeFrame: Any visit during participants' age above 21 Months and up to 24 Months
measure: Body Length During >24 to <=30 Months of Participant's Age
timeFrame: Any visit during participants' age above 24 Months and up to 30 Months
measure: Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 2 Months
measure: Body Weight at 8 Months of Participant's Age
timeFrame: At 8 Months of participants' age
measure: Body Weight at 15 Months of Participant's Age
timeFrame: At 15 Months of participants' age
measure: Body Weight During 0 to <=3 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 3 Months
measure: Body Weight During >3 to <=6 Months of Participant's Age
timeFrame: Any visit during participants' age above 3 Months and up to 6 Months
measure: Body Weight During >6 to <=9 Months of Participant's Age
timeFrame: Any visit during participants' age above 6 Months and up to 9 Months
measure: Body Weight During >15 to <=18 Months of Participant's Age
timeFrame: Any visit during participants' age above 15 Months and up to 18 Months
measure: Body Weight During >21 to <=24 Months of Participant's Age
timeFrame: Any visit during participants' age above 21 Months and up to 24 Months
measure: Body Weight During >24 to <=30 Months of Participant's Age
timeFrame: Any visit during participants' age above 24 Months up to 30 Months
measure: Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 2 Months
measure: Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age
timeFrame: At 8 Months of participants' age
measure: Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age
timeFrame: At 15 Months participants' age
measure: Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 3 Months
measure: Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age
timeFrame: Any visit during participants' age above 3 Months and up to 6 Months
measure: Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age
timeFrame: Any visit during participants' age above 6 Months and up to 9 Months
measure: Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age
timeFrame: Any visit during participants' age above 15 Months and up to 18 Months
measure: Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age
timeFrame: Any visit during participants' age above 21 Months and up to 24 Months
measure: Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age
timeFrame: Any visit during participants' age above 24 Months and up to 30 Months
measure: Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 2 Months
measure: Pulse Rate at 8 Months of Participant's Age
timeFrame: At 8 Months of participants' age
measure: Pulse Rate at 15 Months of Participant's Age
timeFrame: At 15 Months of participants' age
measure: Pulse Rate During 0 to <=3 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 3 Months
measure: Pulse Rate During >3 to <=6 Months of Participant's Age
timeFrame: Any visit during participants' age above 3 Months and up to 6 Months
measure: Pulse Rate During >6 to <=9 Months of Participant's Age
timeFrame: Any visit during participants' age above 6 Months and up to 9 Months
measure: Pulse Rate During >15 to <=18 Months of Participant's Age
timeFrame: Any visit during participants' age above 15 Months and up to 18 Months
measure: Pulse Rate During >21 to <=24 Months of Participant's Age
timeFrame: Any visit during participants' age above 21 Months and up to 24 Months
measure: Pulse Rate During >24 to <=30 Months of Participant's Age
timeFrame: Any visit during participants' age above 24 Months and up to 30 Months
measure: Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 2 Months
measure: Temperature at 8 Months of Participant's Age
timeFrame: At 8 Months of participants' age
measure: Temperature at 15 Months of Participant's Age
timeFrame: At 15 Months of participants' age
measure: Temperature During 0 to <=3 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 3 Months
measure: Temperature During >3 to <=6 Months of Participant's Age
timeFrame: Any visit during participants' age above 3 Months and up to 6 Months
measure: Temperature During >6 to <=9 Months of Participant's Age
timeFrame: Any visit during participants' age above 6 Months and up to 9 Months
measure: Temperature During >15 to <=18 Months of Participant's Age
timeFrame: Any visit during participants' age above 15 Months and up to 18 Months
measure: Temperature During >21 to <=24 Months of Participant's Age
timeFrame: Any visit during participants' age above 21 Months and up to 24 Months
measure: Temperature During >24 to <=30 Months of Participant's Age
timeFrame: Any visit during participants' age above 24 Months and up to 30 Months
measure: Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 2 Months
measure: Respiratory Rate at 8 Months of Participant's Age
timeFrame: At 8 Months of participants' age
measure: Respiratory Rate at 15 Months of Participant's Age
timeFrame: At 15 Months participants' age
measure: Respiratory Rate During 0 to <=3 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 3 Months
measure: Respiratory Rate During >3 to <=6 Months of Participant's Age
timeFrame: Any visit during participants' age above 3 Months and up to 6 Months
measure: Respiratory Rate During >6 to <=9 Months of Participant's Age
timeFrame: Any visit during participants' age above 6 Months and up to 9 Months
measure: Respiratory Rate During >15 to <=18 Months of Participant's Age
timeFrame: Any visit during participants' age above 15 Months and up to 18 Months
measure: Respiratory Rate During >21 to <=24 Months of Participant's Age
timeFrame: Any visit during participants' age above 21 Months and up to 24 Months
measure: Respiratory Rate During >24 to <=30 Months of Participant's Age
timeFrame: Any visit during participants' age above 24 Months and up to 30 Months
measure: Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
timeFrame: Any visit during participants' age from 0 to 2 Months
measure: Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age
timeFrame: At 8 Months of participants' age
measure: Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age
timeFrame: At 15 Months of participants' age
measure: Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)
timeFrame: Follow-up Visit 1 (At the age of Month 20)
measure: Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)
timeFrame: Follow-up Visit 2 (At the age of 26 Months)
measure: Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age
timeFrame: At 8 Months of participants' age
measure: Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age
timeFrame: At 15 Months of participants' age
measure: Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)
timeFrame: Follow-up Visit 1 (At the age of Month 20)
measure: Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)
timeFrame: Follow-up Visit 2 (At the age of Month 26)
measure: Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age
timeFrame: At 8 Months of participants' age
measure: Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age
timeFrame: At 15 Months of participants' age
measure: Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 1 (Month 20 of Participant's Age)
timeFrame: Follow-up Visit 1 (At the age of Month 20)
measure: Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 2 (Month 26 of Participant's Age)
timeFrame: Follow-up Visit 2 (At the age of Month 26)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
city: Sarasota
country: United States
facility: Gulfcoast Research Institute
state: Florida
city: Sarasota
country: United States
facility: Kennedy and White Orthopaedic Center
state: Florida
city: Tampa
country: United States
facility: Pediatric Epilepsy & Neurology Specialists
state: Florida
city: Lafayette
country: United States
facility: Lafayette Clinical Research Group
state: Indiana
city: Lafayette
country: United States
facility: Preferred Pediatrics
state: Indiana
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: