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
Overview
- Phase
- Phase 3
- Intervention
- Investigational medical product (IMP) administered in parent study
- Conditions
- Osteoarthritis
- Sponsor
- Pfizer
- Enrollment
- 4
- Locations
- 6
- Primary Endpoint
- Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
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.
Arms & Interventions
Cohort 1
Long term observational study of subjects from tanezumab parent study
Intervention: Investigational medical product (IMP) administered in parent study
Outcomes
Primary Outcomes
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Occipital-frontal Head Circumference at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' 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
Time Frame: Any visit during participants' age from 0 to 3 Months
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Occipital-frontal Head Circumference at 15 Months of Participant's Age
Time Frame: At 15 Months of participants' 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
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Occipital-frontal head circumference of participants in cm was reported.
Body Length at 15 Months of Participant's Age
Time Frame: 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
Time Frame: Any visit during participants' age from 0 to 3 Months
Body length of participants in cm was reported.
Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Occipital-frontal head circumference of participants in cm was reported.
Body Length at 8 Months of Participant's Age
Time Frame: At 8 Months of participant's age
Body length of participants in cm was reported.
Body Length During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Body length of participants in cm was reported.
Body Length During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Body length of participants in cm was reported.
Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Body length of participants in cm was reported.
Body Length During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Body length of participants in cm was reported.
Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Body weight of participants in kilogram (kg) was reported.
Body Weight at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Body weight of participants in kilogram (kg) was reported.
Body Weight at 15 Months of Participant's Age
Time Frame: At 15 Months of participants' age
Body weight of participants in kilogram (kg) was reported.
Body Weight During 0 to <=3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Body weight of participants in kilogram (kg) was reported.
Body Weight During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Body weight of participants in kg was reported.
Body Weight During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Body weight of participants in kg was reported.
Body Weight During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Body weight of participants in kg was reported.
Body Weight During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Body weight of participants in kg was reported.
Body Weight During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months up to 30 Months
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
Time Frame: Any visit during participants' age from 0 to 2 Months
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Body Length During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Body length of participants in cm was reported.
Body Length During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Body length of participants in cm was reported.
Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' 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
Time Frame: At 15 Months participants' 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
Time Frame: Any visit during participants' age from 0 to 3 Months
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
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
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
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
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
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
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
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
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
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
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
Time Frame: Any visit during participants' age from 0 to 2 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Pulse rate of participants in beats per minute was reported.
Pulse Rate at 15 Months of Participant's Age
Time Frame: At 15 Months of participants' age
Pulse rate of participants in beats per minute was reported.
Pulse Rate During 0 to <=3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Pulse rate of participants in beats per minute was reported.
Temperature at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Temperature of participants in degree Celsius was reported.
Respiratory Rate at 15 Months of Participant's Age
Time Frame: At 15 Months participants' age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During 0 to <=3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Respiratory rate of participants in breaths per minute was reported.
Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' 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.
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age
Time Frame: At 15 Months of participants' 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)
Time Frame: Follow-up Visit 1 (At the age of Month 20)
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.
Pulse Rate During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Pulse rate of participants in beats per minute was reported.
Respiratory Rate During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Respiratory rate of participants in breaths per minute was reported.
Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age
Time Frame: At 15 Months of participants' 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.
Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Temperature of participants in degree Celsius was reported.
Temperature at 15 Months of Participant's Age
Time Frame: At 15 Months of participants' age
Temperature of participants in degree Celsius was reported.
Temperature During >6 to <=9 Months of Participant's Age
Time Frame: Any visit during participants' age above 6 Months and up to 9 Months
Temperature of participants in degree Celsius was reported.
Temperature During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Temperature of participants in degree Celsius was reported.
Temperature During >21 to <=24 Months of Participant's Age
Time Frame: Any visit during participants' age above 21 Months and up to 24 Months
Temperature of participants in degree Celsius was reported.
Temperature During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Temperature of participants in degree Celsius was reported.
Respiratory Rate at 8 Months of Participant's Age
Time Frame: At 8 Months of participants' age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >24 to <=30 Months of Participant's Age
Time Frame: Any visit during participants' age above 24 Months and up to 30 Months
Respiratory rate of participants in breaths per minute was reported.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)
Time Frame: Follow-up Visit 1 (At the age of Month 20)
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.
Temperature During 0 to <=3 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 3 Months
Temperature of participants in degree Celsius was reported.
Temperature During >3 to <=6 Months of Participant's Age
Time Frame: Any visit during participants' age above 3 Months and up to 6 Months
Temperature of participants in degree Celsius was reported.
Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >15 to <=18 Months of Participant's Age
Time Frame: Any visit during participants' age above 15 Months and up to 18 Months
Respiratory rate of participants in breaths per minute was reported.
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)
Time Frame: Follow-up Visit 1 (At the age of Month 20)
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)
Time Frame: Follow-up Visit 2 (At the age of 26 Months)
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 During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time Frame: Any visit during participants' age from 0 to 2 Months
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 15 of Participant's Age
Time Frame: At 15 Months of participants' 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 8 of Participant's Age
Time Frame: At 8 Months of participants' 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)
Time Frame: Follow-up Visit 2 (At the age of Month 26)
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
Time Frame: At 8 Months of participants' 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)
Time Frame: Follow-up Visit 2 (At the age of Month 26)
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.