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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03031938
Other study ID # A4091065
Secondary ID 2013-002548-10IN
Status Completed
Phase Phase 3
First received
Last updated
Start date November 3, 2017
Est. completion date June 4, 2020

Study information

Verified date June 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date June 4, 2020
Est. primary completion date June 4, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Months
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
United States Lafayette Clinical Research Group Lafayette Indiana
United States Preferred Pediatrics Lafayette Indiana
United States USC Keck School of Medicine Los Angeles California
United States Gulfcoast Research Institute Sarasota Florida
United States Kennedy and White Orthopaedic Center Sarasota Florida
United States Pediatric Epilepsy & Neurology Specialists Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Pfizer Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Any visit during participants' age from 0 to 2 Months
Primary Occipital-frontal Head Circumference at 8 Months of Participant's Age Occipital-frontal head circumference of participants in centimeter (cm) was reported. At 8 Months of participants' age
Primary Occipital-frontal Head Circumference at 15 Months of Participant's Age Occipital-frontal head circumference of participants in centimeter (cm) was reported. At 15 Months of participants' age
Primary 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. Any visit during participants' age from 0 to 3 Months
Primary 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. Any visit during participants' age above 3 Months and up to 6 Months
Primary Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age Occipital-frontal head circumference of participants in cm was reported. Any visit during participants' age above 6 Months and up to 9 Months
Primary Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age Occipital-frontal head circumference of participants in cm was reported. Any visit during participants' age above 15 Months and up to 18 Months
Primary Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age Occipital-frontal head circumference of participants in cm was reported. Any visit during participants' age above 21 Months and up to 24 Months
Primary Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age Occipital-frontal head circumference of participants in cm was reported. Any visit during participants' age above 24 Months and up to 30 Months
Primary Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age Body length of participants in cm was reported. Any visit during participants' age from 0 to 2 Months
Primary Body Length at 8 Months of Participant's Age Body length of participants in cm was reported. At 8 Months of participant's age
Primary Body Length at 15 Months of Participant's Age Body length of participants in cm was reported. At 15 Months of participant's age
Primary Body Length During 0 to <=3 Months of Participant's Age Body length of participants in cm was reported. Any visit during participants' age from 0 to 3 Months
Primary Body Length During >3 to <=6 Months of Participant's Age Body length of participants in cm was reported. Any visit during participants' age above 3 Months and up to 6 Months
Primary Body Length During >6 to <=9 Months of Participant's Age Body length of participants in cm was reported. Any visit during participants' age above 6 Months and up to 9 Months
Primary Body Length During >15 to <=18 Months of Participant's Age Body length of participants in cm was reported. Any visit during participants' age above 15 Months and up to 18 Months
Primary Body Length During >21 to <=24 Months of Participant's Age Body length of participants in cm was reported. Any visit during participants' age above 21 Months and up to 24 Months
Primary Body Length During >24 to <=30 Months of Participant's Age Body length of participants in cm was reported. Any visit during participants' age above 24 Months and up to 30 Months
Primary 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. Any visit during participants' age from 0 to 2 Months
Primary Body Weight at 8 Months of Participant's Age Body weight of participants in kilogram (kg) was reported. At 8 Months of participants' age
Primary Body Weight at 15 Months of Participant's Age Body weight of participants in kilogram (kg) was reported. At 15 Months of participants' age
Primary Body Weight During 0 to <=3 Months of Participant's Age Body weight of participants in kilogram (kg) was reported. Any visit during participants' age from 0 to 3 Months
Primary Body Weight During >3 to <=6 Months of Participant's Age Body weight of participants in kg was reported. Any visit during participants' age above 3 Months and up to 6 Months
Primary Body Weight During >6 to <=9 Months of Participant's Age Body weight of participants in kg was reported. Any visit during participants' age above 6 Months and up to 9 Months
Primary Body Weight During >15 to <=18 Months of Participant's Age Body weight of participants in kg was reported. Any visit during participants' age above 15 Months and up to 18 Months
Primary Body Weight During >21 to <=24 Months of Participant's Age Body weight of participants in kg was reported. Any visit during participants' age above 21 Months and up to 24 Months
Primary Body Weight During >24 to <=30 Months of Participant's Age Body weight of participants in kg was reported. Any visit during participants' age above 24 Months up to 30 Months
Primary 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. Any visit during participants' age from 0 to 2 Months
Primary 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. At 8 Months of participants' age
Primary 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. At 15 Months participants' age
Primary 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. Any visit during participants' age from 0 to 3 Months
Primary 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. Any visit during participants' age above 3 Months and up to 6 Months
Primary 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. Any visit during participants' age above 6 Months and up to 9 Months
Primary 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. Any visit during participants' age above 15 Months and up to 18 Months
Primary 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. Any visit during participants' age above 21 Months and up to 24 Months
Primary 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. Any visit during participants' age above 24 Months and up to 30 Months
Primary 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. Any visit during participants' age from 0 to 2 Months
Primary Pulse Rate at 8 Months of Participant's Age Pulse rate of participants in beats per minute was reported. At 8 Months of participants' age
Primary Pulse Rate at 15 Months of Participant's Age Pulse rate of participants in beats per minute was reported. At 15 Months of participants' age
Primary Pulse Rate During 0 to <=3 Months of Participant's Age Pulse rate of participants in beats per minute was reported. Any visit during participants' age from 0 to 3 Months
Primary Pulse Rate During >3 to <=6 Months of Participant's Age Pulse rate of participants in beats per minute was reported. Any visit during participants' age above 3 Months and up to 6 Months
Primary Pulse Rate During >6 to <=9 Months of Participant's Age Pulse rate of participants in beats per minute was reported. Any visit during participants' age above 6 Months and up to 9 Months
Primary Pulse Rate During >15 to <=18 Months of Participant's Age Pulse rate of participants in beats per minute was reported. Any visit during participants' age above 15 Months and up to 18 Months
Primary Pulse Rate During >21 to <=24 Months of Participant's Age Pulse rate of participants in beats per minute was reported. Any visit during participants' age above 21 Months and up to 24 Months
Primary Pulse Rate During >24 to <=30 Months of Participant's Age Pulse rate of participants in beats per minute was reported. Any visit during participants' age above 24 Months and up to 30 Months
Primary Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age Temperature of participants in degree Celsius was reported. Any visit during participants' age from 0 to 2 Months
Primary Temperature at 8 Months of Participant's Age Temperature of participants in degree Celsius was reported. At 8 Months of participants' age
Primary Temperature at 15 Months of Participant's Age Temperature of participants in degree Celsius was reported. At 15 Months of participants' age
Primary Temperature During 0 to <=3 Months of Participant's Age Temperature of participants in degree Celsius was reported. Any visit during participants' age from 0 to 3 Months
Primary Temperature During >3 to <=6 Months of Participant's Age Temperature of participants in degree Celsius was reported. Any visit during participants' age above 3 Months and up to 6 Months
Primary Temperature During >6 to <=9 Months of Participant's Age Temperature of participants in degree Celsius was reported. Any visit during participants' age above 6 Months and up to 9 Months
Primary Temperature During >15 to <=18 Months of Participant's Age Temperature of participants in degree Celsius was reported. Any visit during participants' age above 15 Months and up to 18 Months
Primary Temperature During >21 to <=24 Months of Participant's Age Temperature of participants in degree Celsius was reported. Any visit during participants' age above 21 Months and up to 24 Months
Primary Temperature During >24 to <=30 Months of Participant's Age Temperature of participants in degree Celsius was reported. Any visit during participants' age above 24 Months and up to 30 Months
Primary 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. Any visit during participants' age from 0 to 2 Months
Primary Respiratory Rate at 8 Months of Participant's Age Respiratory rate of participants in breaths per minute was reported. At 8 Months of participants' age
Primary Respiratory Rate at 15 Months of Participant's Age Respiratory rate of participants in breaths per minute was reported. At 15 Months participants' age
Primary Respiratory Rate During 0 to <=3 Months of Participant's Age Respiratory rate of participants in breaths per minute was reported. Any visit during participants' age from 0 to 3 Months
Primary Respiratory Rate During >3 to <=6 Months of Participant's Age Respiratory rate of participants in breaths per minute was reported. Any visit during participants' age above 3 Months and up to 6 Months
Primary Respiratory Rate During >6 to <=9 Months of Participant's Age Respiratory rate of participants in breaths per minute was reported. Any visit during participants' age above 6 Months and up to 9 Months
Primary Respiratory Rate During >15 to <=18 Months of Participant's Age Respiratory rate of participants in breaths per minute was reported. Any visit during participants' age above 15 Months and up to 18 Months
Primary Respiratory Rate During >21 to <=24 Months of Participant's Age Respiratory rate of participants in breaths per minute was reported. Any visit during participants' age above 21 Months and up to 24 Months
Primary Respiratory Rate During >24 to <=30 Months of Participant's Age Respiratory rate of participants in breaths per minute was reported. Any visit during participants' age above 24 Months and up to 30 Months
Primary 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. Any visit during participants' age from 0 to 2 Months
Primary 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. At 8 Months of participants' age
Primary 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. At 15 Months of participants' age
Primary 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. Follow-up Visit 1 (At the age of Month 20)
Primary 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. Follow-up Visit 2 (At the age of 26 Months)
Primary 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. At 8 Months of participants' age
Primary 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. At 15 Months of participants' age
Primary 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. Follow-up Visit 1 (At the age of Month 20)
Primary 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. Follow-up Visit 2 (At the age of Month 26)
Primary 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. At 8 Months of participants' age
Primary 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. At 15 Months of participants' age
Primary 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. Follow-up Visit 1 (At the age of Month 20)
Primary 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. Follow-up Visit 2 (At the age of Month 26)
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