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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

Primary Purpose

Osteoarthritis, Cancer Pain, Recurrent Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Investigational medical product (IMP) administered in parent study
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis focused on measuring Exposure in utero in tanezumab program

Eligibility Criteria

0 Years - 2 Months (Child)All SexesDoes not accept 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:

  • There are no exclusion criteria for participating in this study.

Sites / Locations

  • USC Keck School of Medicine
  • Gulfcoast Research Institute
  • Kennedy and White Orthopaedic Center
  • Pediatric Epilepsy & Neurology Specialists
  • Lafayette Clinical Research Group
  • Preferred Pediatrics

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cohort 1

Arm Description

Long term observational study of subjects from tanezumab parent study

Outcomes

Primary Outcome Measures

Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Occipital-frontal Head Circumference at 8 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Occipital-frontal Head Circumference at 15 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Body length of participants in cm was reported.
Body Length at 8 Months of Participant's Age
Body length of participants in cm was reported.
Body Length at 15 Months of Participant's Age
Body length of participants in cm was reported.
Body Length During 0 to <=3 Months of Participant's Age
Body length of participants in cm was reported.
Body Length During >3 to <=6 Months of Participant's Age
Body length of participants in cm was reported.
Body Length During >6 to <=9 Months of Participant's Age
Body length of participants in cm was reported.
Body Length During >15 to <=18 Months of Participant's Age
Body length of participants in cm was reported.
Body Length During >21 to <=24 Months of Participant's Age
Body length of participants in cm was reported.
Body Length During >24 to <=30 Months of Participant's Age
Body length of participants in cm was reported.
Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Body Weight at 8 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Body Weight at 15 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Body Weight During 0 to <=3 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Body Weight During >3 to <=6 Months of Participant's Age
Body weight of participants in kg was reported.
Body Weight During >6 to <=9 Months of Participant's Age
Body weight of participants in kg was reported.
Body Weight During >15 to <=18 Months of Participant's Age
Body weight of participants in kg was reported.
Body Weight During >21 to <=24 Months of Participant's Age
Body weight of participants in kg was reported.
Body Weight During >24 to <=30 Months of Participant's Age
Body weight of participants in kg was reported.
Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Pulse Rate at 8 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Pulse Rate at 15 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Pulse Rate During 0 to <=3 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >3 to <=6 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >6 to <=9 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >15 to <=18 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >21 to <=24 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >24 to <=30 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Temperature at 8 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Temperature at 15 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Temperature During 0 to <=3 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Temperature During >3 to <=6 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Temperature During >6 to <=9 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Temperature During >15 to <=18 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Temperature During >21 to <=24 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Temperature During >24 to <=30 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate at 8 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate at 15 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During 0 to <=3 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >3 to <=6 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >6 to <=9 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >15 to <=18 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >21 to <=24 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >24 to <=30 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
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)
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
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)
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2017
Last Updated
June 1, 2021
Sponsor
Pfizer
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03031938
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
June 4, 2020 (Actual)
Study Completion Date
June 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Cancer Pain, Recurrent Low Back Pain
Keywords
Exposure in utero in tanezumab program

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Other
Arm Description
Long term observational study of subjects from tanezumab parent study
Intervention Type
Drug
Intervention Name(s)
Investigational medical product (IMP) administered in parent study
Intervention Description
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study
Primary Outcome Measure Information:
Title
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Description
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Time Frame
Any visit during participants' age from 0 to 2 Months
Title
Occipital-frontal Head Circumference at 8 Months of Participant's Age
Description
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Time Frame
At 8 Months of participants' age
Title
Occipital-frontal Head Circumference at 15 Months of Participant's Age
Description
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Time Frame
At 15 Months of participants' age
Title
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age
Description
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Time Frame
Any visit during participants' age from 0 to 3 Months
Title
Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age
Description
Occipital-frontal head circumference of participants in cm was reported.
Time Frame
Any visit during participants' age above 3 Months and up to 6 Months
Title
Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age
Description
Occipital-frontal head circumference of participants in cm was reported.
Time Frame
Any visit during participants' age above 6 Months and up to 9 Months
Title
Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age
Description
Occipital-frontal head circumference of participants in cm was reported.
Time Frame
Any visit during participants' age above 15 Months and up to 18 Months
Title
Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age
Description
Occipital-frontal head circumference of participants in cm was reported.
Time Frame
Any visit during participants' age above 21 Months and up to 24 Months
Title
Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age
Description
Occipital-frontal head circumference of participants in cm was reported.
Time Frame
Any visit during participants' age above 24 Months and up to 30 Months
Title
Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Description
Body length of participants in cm was reported.
Time Frame
Any visit during participants' age from 0 to 2 Months
Title
Body Length at 8 Months of Participant's Age
Description
Body length of participants in cm was reported.
Time Frame
At 8 Months of participant's age
Title
Body Length at 15 Months of Participant's Age
Description
Body length of participants in cm was reported.
Time Frame
At 15 Months of participant's age
Title
Body Length During 0 to <=3 Months of Participant's Age
Description
Body length of participants in cm was reported.
Time Frame
Any visit during participants' age from 0 to 3 Months
Title
Body Length During >3 to <=6 Months of Participant's Age
Description
Body length of participants in cm was reported.
Time Frame
Any visit during participants' age above 3 Months and up to 6 Months
Title
Body Length During >6 to <=9 Months of Participant's Age
Description
Body length of participants in cm was reported.
Time Frame
Any visit during participants' age above 6 Months and up to 9 Months
Title
Body Length During >15 to <=18 Months of Participant's Age
Description
Body length of participants in cm was reported.
Time Frame
Any visit during participants' age above 15 Months and up to 18 Months
Title
Body Length During >21 to <=24 Months of Participant's Age
Description
Body length of participants in cm was reported.
Time Frame
Any visit during participants' age above 21 Months and up to 24 Months
Title
Body Length During >24 to <=30 Months of Participant's Age
Description
Body length of participants in cm was reported.
Time Frame
Any visit during participants' age above 24 Months and up to 30 Months
Title
Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Description
Body weight of participants in kilogram (kg) was reported.
Time Frame
Any visit during participants' age from 0 to 2 Months
Title
Body Weight at 8 Months of Participant's Age
Description
Body weight of participants in kilogram (kg) was reported.
Time Frame
At 8 Months of participants' age
Title
Body Weight at 15 Months of Participant's Age
Description
Body weight of participants in kilogram (kg) was reported.
Time Frame
At 15 Months of participants' age
Title
Body Weight During 0 to <=3 Months of Participant's Age
Description
Body weight of participants in kilogram (kg) was reported.
Time Frame
Any visit during participants' age from 0 to 3 Months
Title
Body Weight During >3 to <=6 Months of Participant's Age
Description
Body weight of participants in kg was reported.
Time Frame
Any visit during participants' age above 3 Months and up to 6 Months
Title
Body Weight During >6 to <=9 Months of Participant's Age
Description
Body weight of participants in kg was reported.
Time Frame
Any visit during participants' age above 6 Months and up to 9 Months
Title
Body Weight During >15 to <=18 Months of Participant's Age
Description
Body weight of participants in kg was reported.
Time Frame
Any visit during participants' age above 15 Months and up to 18 Months
Title
Body Weight During >21 to <=24 Months of Participant's Age
Description
Body weight of participants in kg was reported.
Time Frame
Any visit during participants' age above 21 Months and up to 24 Months
Title
Body Weight During >24 to <=30 Months of Participant's Age
Description
Body weight of participants in kg was reported.
Time Frame
Any visit during participants' age above 24 Months up to 30 Months
Title
Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Description
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Time Frame
Any visit during participants' age from 0 to 2 Months
Title
Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age
Description
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Time Frame
At 8 Months of participants' age
Title
Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age
Description
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Time Frame
At 15 Months participants' age
Title
Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age
Description
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Time Frame
Any visit during participants' age from 0 to 3 Months
Title
Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age
Description
Systolic and diastolic blood pressure of participants in mmHg was reported.
Time Frame
Any visit during participants' age above 3 Months and up to 6 Months
Title
Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age
Description
Systolic and diastolic blood pressure of participants in mmHg was reported.
Time Frame
Any visit during participants' age above 6 Months and up to 9 Months
Title
Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age
Description
Systolic and diastolic blood pressure of participants in mmHg was reported.
Time Frame
Any visit during participants' age above 15 Months and up to 18 Months
Title
Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age
Description
Systolic and diastolic blood pressure of participants in mmHg was reported.
Time Frame
Any visit during participants' age above 21 Months and up to 24 Months
Title
Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age
Description
Systolic and diastolic blood pressure of participants in mmHg was reported.
Time Frame
Any visit during participants' age above 24 Months and up to 30 Months
Title
Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Description
Pulse rate of participants in beats per minute was reported.
Time Frame
Any visit during participants' age from 0 to 2 Months
Title
Pulse Rate at 8 Months of Participant's Age
Description
Pulse rate of participants in beats per minute was reported.
Time Frame
At 8 Months of participants' age
Title
Pulse Rate at 15 Months of Participant's Age
Description
Pulse rate of participants in beats per minute was reported.
Time Frame
At 15 Months of participants' age
Title
Pulse Rate During 0 to <=3 Months of Participant's Age
Description
Pulse rate of participants in beats per minute was reported.
Time Frame
Any visit during participants' age from 0 to 3 Months
Title
Pulse Rate During >3 to <=6 Months of Participant's Age
Description
Pulse rate of participants in beats per minute was reported.
Time Frame
Any visit during participants' age above 3 Months and up to 6 Months
Title
Pulse Rate During >6 to <=9 Months of Participant's Age
Description
Pulse rate of participants in beats per minute was reported.
Time Frame
Any visit during participants' age above 6 Months and up to 9 Months
Title
Pulse Rate During >15 to <=18 Months of Participant's Age
Description
Pulse rate of participants in beats per minute was reported.
Time Frame
Any visit during participants' age above 15 Months and up to 18 Months
Title
Pulse Rate During >21 to <=24 Months of Participant's Age
Description
Pulse rate of participants in beats per minute was reported.
Time Frame
Any visit during participants' age above 21 Months and up to 24 Months
Title
Pulse Rate During >24 to <=30 Months of Participant's Age
Description
Pulse rate of participants in beats per minute was reported.
Time Frame
Any visit during participants' age above 24 Months and up to 30 Months
Title
Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Description
Temperature of participants in degree Celsius was reported.
Time Frame
Any visit during participants' age from 0 to 2 Months
Title
Temperature at 8 Months of Participant's Age
Description
Temperature of participants in degree Celsius was reported.
Time Frame
At 8 Months of participants' age
Title
Temperature at 15 Months of Participant's Age
Description
Temperature of participants in degree Celsius was reported.
Time Frame
At 15 Months of participants' age
Title
Temperature During 0 to <=3 Months of Participant's Age
Description
Temperature of participants in degree Celsius was reported.
Time Frame
Any visit during participants' age from 0 to 3 Months
Title
Temperature During >3 to <=6 Months of Participant's Age
Description
Temperature of participants in degree Celsius was reported.
Time Frame
Any visit during participants' age above 3 Months and up to 6 Months
Title
Temperature During >6 to <=9 Months of Participant's Age
Description
Temperature of participants in degree Celsius was reported.
Time Frame
Any visit during participants' age above 6 Months and up to 9 Months
Title
Temperature During >15 to <=18 Months of Participant's Age
Description
Temperature of participants in degree Celsius was reported.
Time Frame
Any visit during participants' age above 15 Months and up to 18 Months
Title
Temperature During >21 to <=24 Months of Participant's Age
Description
Temperature of participants in degree Celsius was reported.
Time Frame
Any visit during participants' age above 21 Months and up to 24 Months
Title
Temperature During >24 to <=30 Months of Participant's Age
Description
Temperature of participants in degree Celsius was reported.
Time Frame
Any visit during participants' age above 24 Months and up to 30 Months
Title
Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Description
Respiratory rate of participants in breaths per minute was reported.
Time Frame
Any visit during participants' age from 0 to 2 Months
Title
Respiratory Rate at 8 Months of Participant's Age
Description
Respiratory rate of participants in breaths per minute was reported.
Time Frame
At 8 Months of participants' age
Title
Respiratory Rate at 15 Months of Participant's Age
Description
Respiratory rate of participants in breaths per minute was reported.
Time Frame
At 15 Months participants' age
Title
Respiratory Rate During 0 to <=3 Months of Participant's Age
Description
Respiratory rate of participants in breaths per minute was reported.
Time Frame
Any visit during participants' age from 0 to 3 Months
Title
Respiratory Rate During >3 to <=6 Months of Participant's Age
Description
Respiratory rate of participants in breaths per minute was reported.
Time Frame
Any visit during participants' age above 3 Months and up to 6 Months
Title
Respiratory Rate During >6 to <=9 Months of Participant's Age
Description
Respiratory rate of participants in breaths per minute was reported.
Time Frame
Any visit during participants' age above 6 Months and up to 9 Months
Title
Respiratory Rate During >15 to <=18 Months of Participant's Age
Description
Respiratory rate of participants in breaths per minute was reported.
Time Frame
Any visit during participants' age above 15 Months and up to 18 Months
Title
Respiratory Rate During >21 to <=24 Months of Participant's Age
Description
Respiratory rate of participants in breaths per minute was reported.
Time Frame
Any visit during participants' age above 21 Months and up to 24 Months
Title
Respiratory Rate During >24 to <=30 Months of Participant's Age
Description
Respiratory rate of participants in breaths per minute was reported.
Time Frame
Any visit during participants' age above 24 Months and up to 30 Months
Title
Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Description
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Time Frame
Any visit during participants' age from 0 to 2 Months
Title
Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age
Description
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Time Frame
At 8 Months of participants' age
Title
Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age
Description
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Time Frame
At 15 Months of participants' age
Title
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)
Description
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Time Frame
Follow-up Visit 1 (At the age of Month 20)
Title
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)
Description
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Time Frame
Follow-up Visit 2 (At the age of 26 Months)
Title
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age
Description
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Time Frame
At 8 Months of participants' age
Title
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age
Description
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Time Frame
At 15 Months of participants' age
Title
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)
Description
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Time Frame
Follow-up Visit 1 (At the age of Month 20)
Title
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)
Description
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.
Time Frame
Follow-up Visit 2 (At the age of Month 26)
Title
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age
Description
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Time Frame
At 8 Months of participants' age
Title
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age
Description
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Time Frame
At 15 Months of participants' age
Title
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)
Description
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Time Frame
Follow-up Visit 1 (At the age of Month 20)
Title
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)
Description
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Time Frame
Follow-up Visit 2 (At the age of Month 26)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
USC Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Gulfcoast Research Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Kennedy and White Orthopaedic Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Pediatric Epilepsy & Neurology Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Lafayette Clinical Research Group
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Preferred Pediatrics
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=A4091065
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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