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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031938
• Other study ID #: A4091065
• Secondary ID: 2013-002548-10IN
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Cancer Pain
• Low Back Pain
• Osteoarthritis
• Recurrent Low Back Pain

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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