Phase 3
N=4
Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
Osteoarthritis · Cancer Pain · Recurrent Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03031938 ↗Enrolled (actual)
4
Serious AEs
25.0%
Results posted
Jun 2021
Primary outcome: Primary: Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age — 38.7; 38.7 cm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Investigational medical product (IMP) administered in parent study (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age |
38.7; 38.7 | — |
| PRIMARY Occipital-frontal Head Circumference at 8 Months of Participant's Age |
47.0; 47.2 | — |
| PRIMARY Occipital-frontal Head Circumference at 15 Months of Participant's Age |
49.2; 48.9 | — |
| PRIMARY Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age |
38.7; 38.7 | — |
| PRIMARY Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age |
44.0 | — |
| PRIMARY Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age |
47.0; 47.2 | — |
| PRIMARY Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age |
49.2; 48.9 | — |
| PRIMARY Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age |
49.0 | — |
| PRIMARY Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age |
50.5 | — |
| PRIMARY Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age |
54.6; 56.5 | — |
| PRIMARY Body Length at 8 Months of Participant's Age |
73.6; 73.7 | — |
| PRIMARY Body Length at 15 Months of Participant's Age |
82.3; 81.3 | — |
| PRIMARY Body Length During 0 to <=3 Months of Participant's Age |
54.6; 56.5 | — |
| PRIMARY Body Length During >3 to <=6 Months of Participant's Age |
72.4 | — |
| PRIMARY Body Length During >6 to <=9 Months of Participant's Age |
73.6; 73.7 | — |
| PRIMARY Body Length During >15 to <=18 Months of Participant's Age |
82.3; 81.3 | — |
| PRIMARY Body Length During >21 to <=24 Months of Participant's Age |
92.5 | — |
| PRIMARY Body Length During >24 to <=30 Months of Participant's Age |
97.8 | — |
| PRIMARY Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age |
3.4; 5.8 | — |
| PRIMARY Body Weight at 8 Months of Participant's Age |
11.3; 11.6 | — |
| PRIMARY Body Weight at 15 Months of Participant's Age |
13.6; 13.1 | — |
| PRIMARY Body Weight During 0 to <=3 Months of Participant's Age |
3.4; 5.8 | — |
| PRIMARY Body Weight During >3 to <=6 Months of Participant's Age |
11.3 | — |
| PRIMARY Body Weight During >6 to <=9 Months of Participant's Age |
11.3; 11.6 | — |
| PRIMARY Body Weight During >15 to <=18 Months of Participant's Age |
13.6; 13.1 | — |
| PRIMARY Body Weight During >21 to <=24 Months of Participant's Age |
16.0 | — |
| PRIMARY Body Weight During >24 to <=30 Months of Participant's Age |
18.4 | — |
| PRIMARY Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age |
90.0; NA; 60.0; NA | — |
| PRIMARY Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age |
95.5; 82.0; 66.0; 40.0 | — |
| PRIMARY Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age |
94.5; 80.0; 58.5; 43.0 | — |
| PRIMARY Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age |
90.0; NA; 60.0; NA | — |
| PRIMARY Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age |
— | — |
| PRIMARY Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age |
95.5; 82.0; 66.0; 40.0 | — |
| PRIMARY Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age |
94.5; 80.0; 58.5; 43.0 | — |
| PRIMARY Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age |
123.0; 78.0 | — |
| PRIMARY Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age |
101.0; 55.0 | — |
| PRIMARY Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age |
124.0; 144.0 | — |
| PRIMARY Pulse Rate at 8 Months of Participant's Age |
117.0; 121.0 | — |
| PRIMARY Pulse Rate at 15 Months of Participant's Age |
108.5; 116.0 | — |
| PRIMARY Pulse Rate During 0 to <=3 Months of Participant's Age |
124.0; 144.0 | — |
| PRIMARY Pulse Rate During >3 to <=6 Months of Participant's Age |
128.0 | — |
| PRIMARY Pulse Rate During >6 to <=9 Months of Participant's Age |
117.0; 121.0 | — |
| PRIMARY Pulse Rate During >15 to <=18 Months of Participant's Age |
108.5; 116.0 | — |
| PRIMARY Pulse Rate During >21 to <=24 Months of Participant's Age |
118.0 | — |
| PRIMARY Pulse Rate During >24 to <=30 Months of Participant's Age |
118.0 | — |
| PRIMARY Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age |
36.2; 36.6 | — |
| PRIMARY Temperature at 8 Months of Participant's Age |
36.3; 36.7 | — |
| PRIMARY Temperature at 15 Months of Participant's Age |
36.1; 36.5 | — |
| PRIMARY Temperature During 0 to <=3 Months of Participant's Age |
36.2; 36.6 | — |
| PRIMARY Temperature During >3 to <=6 Months of Participant's Age |
36.4 | — |
| PRIMARY Temperature During >6 to <=9 Months of Participant's Age |
36.3; 36.7 | — |
| PRIMARY Temperature During >15 to <=18 Months of Participant's Age |
36.1; 36.5 | — |
| PRIMARY Temperature During >21 to <=24 Months of Participant's Age |
36.4 | — |
| PRIMARY Temperature During >24 to <=30 Months of Participant's Age |
36.3 | — |
| PRIMARY Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age |
30.0; 57.0 | — |
| PRIMARY Respiratory Rate at 8 Months of Participant's Age |
33.0; 34.0 | — |
| PRIMARY Respiratory Rate at 15 Months of Participant's Age |
34.0; 27.0 | — |
| PRIMARY Respiratory Rate During 0 to <=3 Months of Participant's Age |
30.0; 57.0 | — |
| PRIMARY Respiratory Rate During >3 to <=6 Months of Participant's Age |
44.0 | — |
| PRIMARY Respiratory Rate During >6 to <=9 Months of Participant's Age |
33.0; 34.0 | — |
| PRIMARY Respiratory Rate During >15 to <=18 Months of Participant's Age |
34.0; 27.0 | — |
| PRIMARY Respiratory Rate During >21 to <=24 Months of Participant's Age |
44.0 | — |
| PRIMARY Respiratory Rate During >24 to <=30 Months of Participant's Age |
44.0 | — |
| PRIMARY Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age |
0; 0 | — |
| PRIMARY Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age |
0; 0 | — |
| PRIMARY Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age |
1; 0 | — |
| PRIMARY Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age) |
1; 0 | — |
| PRIMARY Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age) |
1; 0 | — |
| PRIMARY Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age |
NA; NA | — |
| PRIMARY Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age |
NA; NA | — |
| PRIMARY Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age) |
7 | — |
| PRIMARY Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age) |
6 | — |
| PRIMARY Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age |
NA; NA | — |
| PRIMARY Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age |
NA; NA | — |
| 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) |
88 | — |
| 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) |
92 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03031938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.