Trial Outcomes & Findings for Open-label Extension Study Of RN624 (NCT NCT00399490)
NCT ID: NCT00399490
Last Updated: 2021-02-02
Results Overview
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
287 participants
Primary outcome timeframe
Baseline up to 12 weeks after last dose of study drug
Results posted on
2021-02-02
Participant Flow
Participants who had received at least 2 infusions of study drug and had been followed for 56 days after the last infusion in previous study A4091008 (NCT00394563) were eligible to be enrolled in this study.
Participant milestones
| Measure |
Tanezumab 50 mcg/kg
Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|
|
Overall Study
STARTED
|
281
|
|
Overall Study
COMPLETED
|
183
|
|
Overall Study
NOT COMPLETED
|
98
|
Reasons for withdrawal
| Measure |
Tanezumab 50 mcg/kg
Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|
|
Overall Study
Adverse Event
|
19
|
|
Overall Study
Lack of Efficacy
|
31
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Other
|
25
|
Baseline Characteristics
Open-label Extension Study Of RN624
Baseline characteristics by cohort
| Measure |
Tanezumab 50 mcg/kg
n=281 Participants
Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 weeks after last dose of study drugPopulation: Safety population included all participants who had received at least 1 study drug infusion in this study, A4091009 (NCT00399490).
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events.
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=281 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
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|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
168 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72Population: Intent-to-treat (ITT) population included all participants who received at least 1 study drug infusion (in this study,A4091009\[NCT00399490\]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row.
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from the five individual questions scored on a visual analog scale (VAS) of 0 to 100, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 100, where higher scores indicate higher pain.
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=236 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
n=40 Participants
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|---|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4
|
-38.0 units on a scale
Standard Deviation 24.54
|
-39.1 units on a scale
Standard Deviation 21.93
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8
|
-35.9 units on a scale
Standard Deviation 24.68
|
-34.1 units on a scale
Standard Deviation 24.04
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline
|
67.4 units on a scale
Standard Deviation 12.44
|
67.4 units on a scale
Standard Deviation 11.04
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 0
|
-25.3 units on a scale
Standard Deviation 25.68
|
-16.6 units on a scale
Standard Deviation 24.21
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16
|
-33.5 units on a scale
Standard Deviation 25.47
|
-37.3 units on a scale
Standard Deviation 21.42
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24
|
-30.6 units on a scale
Standard Deviation 26.31
|
-34.0 units on a scale
Standard Deviation 22.36
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32
|
-35.4 units on a scale
Standard Deviation 24.25
|
-27.8 units on a scale
Standard Deviation 23.12
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40
|
-27.9 units on a scale
Standard Deviation 25.10
|
-28.5 units on a scale
Standard Deviation 24.91
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48
|
-25.0 units on a scale
Standard Deviation 22.86
|
-26.3 units on a scale
Standard Deviation 23.91
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56
|
-17.2 units on a scale
Standard Deviation 23.82
|
-22.4 units on a scale
Standard Deviation 22.32
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64
|
-18.6 units on a scale
Standard Deviation 24.92
|
-9.7 units on a scale
Standard Deviation 28.70
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72
|
-15.6 units on a scale
Standard Deviation 31.40
|
-28.3 units on a scale
Standard Deviation 5.23
|
SECONDARY outcome
Timeframe: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72Population: ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 \[NCT00399490\]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row.
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from the 2 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC stiffness subscale score is 0 to 100, where higher scores indicate worse function. Stiffness is defined as a sensation of decreased ease in movement of knee.
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=236 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
n=40 Participants
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|---|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline
|
71.9 units on a scale
Standard Deviation 15.21
|
71.6 units on a scale
Standard Deviation 13.65
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 0
|
-25.0 units on a scale
Standard Deviation 27.92
|
-17.4 units on a scale
Standard Deviation 24.27
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4
|
-40.8 units on a scale
Standard Deviation 26.19
|
-42.2 units on a scale
Standard Deviation 21.35
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8
|
-38.9 units on a scale
Standard Deviation 27.50
|
-36.6 units on a scale
Standard Deviation 25.45
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16
|
-34.0 units on a scale
Standard Deviation 27.61
|
-39.7 units on a scale
Standard Deviation 23.93
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24
|
-33.2 units on a scale
Standard Deviation 28.97
|
-34.7 units on a scale
Standard Deviation 24.47
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32
|
-38.1 units on a scale
Standard Deviation 26.20
|
-26.6 units on a scale
Standard Deviation 24.27
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40
|
-27.7 units on a scale
Standard Deviation 30.94
|
-33.0 units on a scale
Standard Deviation 26.57
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48
|
-28.6 units on a scale
Standard Deviation 27.59
|
-26.6 units on a scale
Standard Deviation 24.58
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56
|
-18.7 units on a scale
Standard Deviation 25.96
|
-22.6 units on a scale
Standard Deviation 20.67
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64
|
-22.0 units on a scale
Standard Deviation 29.82
|
-8.1 units on a scale
Standard Deviation 33.04
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72
|
-12.8 units on a scale
Standard Deviation 26.52
|
-19.0 units on a scale
Standard Deviation 14.14
|
SECONDARY outcome
Timeframe: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72Population: ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 \[NCT00399490\]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row.
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 100, where higher scores indicate worse function.
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=236 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
n=40 Participants
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|---|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline
|
66.7 units on a scale
Standard Deviation 13.79
|
67.6 units on a scale
Standard Deviation 13.30
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 0
|
-24.3 units on a scale
Standard Deviation 25.04
|
-15.9 units on a scale
Standard Deviation 22.04
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4
|
-37.9 units on a scale
Standard Deviation 23.94
|
-40.2 units on a scale
Standard Deviation 20.28
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8
|
-35.4 units on a scale
Standard Deviation 24.18
|
-34.9 units on a scale
Standard Deviation 23.10
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16
|
-32.5 units on a scale
Standard Deviation 24.57
|
-38.1 units on a scale
Standard Deviation 23.72
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24
|
-29.1 units on a scale
Standard Deviation 24.62
|
-33.0 units on a scale
Standard Deviation 23.45
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32
|
-33.3 units on a scale
Standard Deviation 24.29
|
-27.1 units on a scale
Standard Deviation 23.95
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40
|
-26.8 units on a scale
Standard Deviation 26.05
|
-30.3 units on a scale
Standard Deviation 22.71
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48
|
-24.1 units on a scale
Standard Deviation 24.55
|
-23.6 units on a scale
Standard Deviation 23.16
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56
|
-14.1 units on a scale
Standard Deviation 24.62
|
-22.7 units on a scale
Standard Deviation 20.35
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64
|
-20.7 units on a scale
Standard Deviation 23.80
|
-7.8 units on a scale
Standard Deviation 28.39
|
|
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72
|
-8.6 units on a scale
Standard Deviation 19.42
|
-21.4 units on a scale
Standard Deviation 4.66
|
SECONDARY outcome
Timeframe: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72Population: ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 \[NCT00399490\]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row.
Participants answered: "In the past 24 hours, how much pain have you had in your index knee caused by your osteoarthritis?" Participants responded by using a VAS of 0 to 100, where 0 = no pain and 100 = extreme pain, higher scores indicated more pain.
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=237 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
n=40 Participants
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|---|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline
|
69.8 units on a scale
Standard Deviation 10.13
|
68.5 units on a scale
Standard Deviation 9.65
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 0
|
-22.0 units on a scale
Standard Deviation 27.46
|
-13.0 units on a scale
Standard Deviation 26.84
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4
|
-36.5 units on a scale
Standard Deviation 25.59
|
-39.6 units on a scale
Standard Deviation 22.31
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8
|
-34.5 units on a scale
Standard Deviation 27.93
|
-31.8 units on a scale
Standard Deviation 27.06
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16
|
-30.2 units on a scale
Standard Deviation 28.43
|
-36.9 units on a scale
Standard Deviation 24.88
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24
|
-28.5 units on a scale
Standard Deviation 29.77
|
-29.6 units on a scale
Standard Deviation 27.95
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32
|
-32.2 units on a scale
Standard Deviation 29.29
|
-21.2 units on a scale
Standard Deviation 28.05
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40
|
-26.6 units on a scale
Standard Deviation 30.78
|
-27.1 units on a scale
Standard Deviation 25.13
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48
|
-22.5 units on a scale
Standard Deviation 27.30
|
-25.2 units on a scale
Standard Deviation 29.83
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56
|
-14.0 units on a scale
Standard Deviation 30.20
|
-8.7 units on a scale
Standard Deviation 28.32
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64
|
-16.4 units on a scale
Standard Deviation 32.61
|
-10.8 units on a scale
Standard Deviation 36.99
|
|
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72
|
-8.4 units on a scale
Standard Deviation 17.15
|
-29.0 units on a scale
Standard Deviation 24.63
|
SECONDARY outcome
Timeframe: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72Population: ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 \[NCT00399490\]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row.
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a VAS of 0 to 100, where 0 = very poor and 100 = very good, where higher scores indicated better health condition.
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=236 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
n=40 Participants
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|---|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline
|
53.3 units on a scale
Standard Deviation 19.79
|
50.5 units on a scale
Standard Deviation 19.63
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 0
|
10.4 units on a scale
Standard Deviation 26.33
|
8.4 units on a scale
Standard Deviation 20.32
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4
|
20.3 units on a scale
Standard Deviation 29.16
|
25.9 units on a scale
Standard Deviation 24.54
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8
|
18.5 units on a scale
Standard Deviation 28.28
|
21.7 units on a scale
Standard Deviation 26.28
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16
|
15.7 units on a scale
Standard Deviation 28.66
|
18.2 units on a scale
Standard Deviation 31.85
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24
|
11.1 units on a scale
Standard Deviation 30.83
|
10.9 units on a scale
Standard Deviation 33.93
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32
|
15.9 units on a scale
Standard Deviation 30.33
|
6.5 units on a scale
Standard Deviation 28.76
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40
|
11.1 units on a scale
Standard Deviation 31.18
|
4.2 units on a scale
Standard Deviation 29.16
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48
|
6.7 units on a scale
Standard Deviation 25.51
|
7.5 units on a scale
Standard Deviation 26.41
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56
|
-8.0 units on a scale
Standard Deviation 32.85
|
6.6 units on a scale
Standard Deviation 18.94
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64
|
9.4 units on a scale
Standard Deviation 22.87
|
0.8 units on a scale
Standard Deviation 30.05
|
|
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72
|
5.0 units on a scale
Standard Deviation 12.73
|
25.5 units on a scale
Standard Deviation 17.68
|
SECONDARY outcome
Timeframe: A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72Population: ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 \[NCT00399490\]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row.
Participants answered: "Overall, how satisfied are you with the study drug treatment you received as part of this study?" Participants responded by selecting the most appropriate among the following responses: not at all satisfied, a little satisfied, somewhat satisfied, and very satisfied.
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=267 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|---|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Baseline: Very Satisfied
|
191 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Baseline: Somewhat Satisfied
|
36 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Baseline: A Little Satisfied
|
14 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Baseline: Not at all Satisfied
|
26 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 4: Very Satisfied
|
189 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 4: Somewhat Satisfied
|
57 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 4: A Little Satisfied
|
11 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 4: Not at all Satisfied
|
2 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 8: Very Satisfied
|
204 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 8: Somewhat Satisfied
|
35 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 8: A Little Satisfied
|
9 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 8: Not at all Satisfied
|
3 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 16: Very Satisfied
|
162 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 16: Somewhat Satisfied
|
36 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 16: A Little Satisfied
|
12 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 16: Not at all Satisfied
|
1 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 24: Very Satisfied
|
139 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 24: Somewhat Satisfied
|
27 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 24: A Little Satisfied
|
8 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 24: Not at all Satisfied
|
1 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 32: Very Satisfied
|
105 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 32: Somewhat Satisfied
|
21 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 32: A Little Satisfied
|
5 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 32: Not at all Satisfied
|
1 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 40: Very Satisfied
|
72 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 40: Somewhat Satisfied
|
10 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 40: A Little Satisfied
|
3 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 40: Not at all Satisfied
|
1 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 48: Very Satisfied
|
46 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 48: Somewhat Satisfied
|
7 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 48: A Little Satisfied
|
3 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 48: Not at all Satisfied
|
0 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 56: Very Satisfied
|
27 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 56: Somewhat Satisfied
|
3 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 56: A Little Satisfied
|
2 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 56: Not at all Satisfied
|
0 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 64: Very Satisfied
|
16 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 64: Somewhat Satisfied
|
2 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 64: A Little Satisfied
|
0 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 64: Not at all Satisfied
|
0 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 72: Very Satisfied
|
4 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 72: Somewhat Satisfied
|
0 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 72: A Little Satisfied
|
0 Participants
|
—
|
|
Number of Participants With Response to Participant Satisfaction Questionnaire
Week 72: Not at all Satisfied
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72Population: ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 \[NCT00399490\]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). The total score for each section and 2 component scores are an average of the individual question scores, which are scaled from 0 to 100, where 0=lowest level of functioning and 100=highest level of functioning, higher scores indicated better functioning .
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=271 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|---|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline: General Health
|
75.9 units on a scale
Standard Deviation 16.97
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline: Physical Function
|
45.4 units on a scale
Standard Deviation 21.40
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline: Role Physical
|
63.3 units on a scale
Standard Deviation 23.61
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline: Bodily Pain
|
50.4 units on a scale
Standard Deviation 19.86
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline: Vitality
|
63.2 units on a scale
Standard Deviation 18.24
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline: Social Functioning
|
83.9 units on a scale
Standard Deviation 19.88
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline: Role Emotional
|
81.3 units on a scale
Standard Deviation 22.54
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline: Mental Health
|
82.8 units on a scale
Standard Deviation 13.45
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4: General Health
|
3.5 units on a scale
Standard Deviation 17.08
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4: Physical Function
|
10.4 units on a scale
Standard Deviation 19.09
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4: Role Physical
|
9.8 units on a scale
Standard Deviation 21.45
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4: Bodily Pain
|
11.3 units on a scale
Standard Deviation 22.90
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4: Vitality
|
6.4 units on a scale
Standard Deviation 18.47
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4: Social Function
|
6.6 units on a scale
Standard Deviation 23.29
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4: Role Emotional
|
6.3 units on a scale
Standard Deviation 23.09
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 4: Mental Health
|
4.8 units on a scale
Standard Deviation 20.39
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8: General Health
|
3.5 units on a scale
Standard Deviation 18.02
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8: Physical Function
|
8.6 units on a scale
Standard Deviation 19.39
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8: Role Physical
|
6.7 units on a scale
Standard Deviation 20.15
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8: Bodily Pain
|
10.9 units on a scale
Standard Deviation 22.11
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8: Vitality
|
4.4 units on a scale
Standard Deviation 18.51
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8: Social Function
|
5.1 units on a scale
Standard Deviation 22.41
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8: Role Emotional
|
5.0 units on a scale
Standard Deviation 22.87
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 8: Mental Health
|
4.3 units on a scale
Standard Deviation 19.11
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16: General Health
|
2.4 units on a scale
Standard Deviation 17.10
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16: Physical Function
|
7.8 units on a scale
Standard Deviation 20.79
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16: Role Physical
|
5.0 units on a scale
Standard Deviation 22.86
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16: Bodily Pain
|
8.5 units on a scale
Standard Deviation 24.93
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16: Vitality
|
3.7 units on a scale
Standard Deviation 19.59
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16: Social Function
|
4.4 units on a scale
Standard Deviation 24.04
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16: Role Emotional
|
3.4 units on a scale
Standard Deviation 23.24
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 16: Mental Health
|
1.4 units on a scale
Standard Deviation 19.21
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24: General Health
|
2.4 units on a scale
Standard Deviation 20.82
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24: Physical Function
|
6.6 units on a scale
Standard Deviation 21.49
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24: Role Physical
|
4.2 units on a scale
Standard Deviation 24.74
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24: Bodily Pain
|
6.1 units on a scale
Standard Deviation 26.06
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24: Vitality
|
4.3 units on a scale
Standard Deviation 21.18
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24: Social Function
|
4.9 units on a scale
Standard Deviation 28.94
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24: Role Emotional
|
4.2 units on a scale
Standard Deviation 27.76
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 24: Mental Health
|
3.4 units on a scale
Standard Deviation 23.40
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32: General Health
|
1.8 units on a scale
Standard Deviation 16.68
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32: Physical Function
|
4.3 units on a scale
Standard Deviation 22.67
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32: Role Physical
|
0.6 units on a scale
Standard Deviation 27.42
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32: Bodily Pain
|
5.9 units on a scale
Standard Deviation 25.26
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32: Vitality
|
-0.7 units on a scale
Standard Deviation 21.17
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32: Social Function
|
1.2 units on a scale
Standard Deviation 26.23
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32: Role Emotional
|
1.3 units on a scale
Standard Deviation 25.79
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 32: Mental Health
|
0.9 units on a scale
Standard Deviation 20.55
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40: General Health
|
1.2 units on a scale
Standard Deviation 20.50
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40: Physical Function
|
4.4 units on a scale
Standard Deviation 25.87
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40: Role Physical
|
3.7 units on a scale
Standard Deviation 28.57
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40: Bodily Pain
|
4.1 units on a scale
Standard Deviation 29.75
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40: Vitality
|
1.7 units on a scale
Standard Deviation 25.69
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40: Social Function
|
3.9 units on a scale
Standard Deviation 28.41
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40: Role Emotional
|
0.7 units on a scale
Standard Deviation 31.17
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 40: Mental Health
|
2.2 units on a scale
Standard Deviation 24.06
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48: General Health
|
2.2 units on a scale
Standard Deviation 22.13
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48: Physical Function
|
-0.9 units on a scale
Standard Deviation 25.28
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48: Role Physical
|
-5.2 units on a scale
Standard Deviation 31.66
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48: Bodily Pain
|
0.4 units on a scale
Standard Deviation 27.77
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48: Vitality
|
-2.8 units on a scale
Standard Deviation 24.14
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48: Social Function
|
-2.1 units on a scale
Standard Deviation 30.99
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48: Role Emotional
|
-5.1 units on a scale
Standard Deviation 32.43
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 48: Mental Health
|
1.4 units on a scale
Standard Deviation 24.70
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56: General Health
|
-0.5 units on a scale
Standard Deviation 19.18
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56: Physical Function
|
-3.5 units on a scale
Standard Deviation 24.90
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56: Role Physical
|
-6.2 units on a scale
Standard Deviation 28.08
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56: Bodily Pain
|
-0.4 units on a scale
Standard Deviation 22.64
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56: Vitality
|
-3.9 units on a scale
Standard Deviation 21.99
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56: Social Function
|
-4.6 units on a scale
Standard Deviation 26.65
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56: Role Emotional
|
-6.2 units on a scale
Standard Deviation 29.92
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 56: Mental Health
|
-6.2 units on a scale
Standard Deviation 21.69
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64: General Health
|
0.5 units on a scale
Standard Deviation 23.42
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64: Physical Function
|
-2.6 units on a scale
Standard Deviation 14.27
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64: Role Physical
|
-1.6 units on a scale
Standard Deviation 25.04
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64: Bodily Pain
|
-2.9 units on a scale
Standard Deviation 22.13
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64: Vitality
|
-4.4 units on a scale
Standard Deviation 24.09
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64: Social Function
|
-0.5 units on a scale
Standard Deviation 32.43
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64: Role Emotional
|
-2.6 units on a scale
Standard Deviation 30.12
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 64: Mental Health
|
2.1 units on a scale
Standard Deviation 26.50
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72: General Health
|
-5.0 units on a scale
Standard Deviation 4.08
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72: Physical Function
|
5.0 units on a scale
Standard Deviation 14.72
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72: Role Physical
|
0.0 units on a scale
Standard Deviation 5.10
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72: Bodily Pain
|
-0.0 units on a scale
Standard Deviation 14.63
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72: Vitality
|
-9.4 units on a scale
Standard Deviation 10.83
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72: Social Function
|
6.3 units on a scale
Standard Deviation 7.22
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72: Role Emotional
|
-10.4 units on a scale
Standard Deviation 12.50
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Change at Week 72: Mental Health
|
-1.3 units on a scale
Standard Deviation 9.46
|
—
|
SECONDARY outcome
Timeframe: A4091009: Baseline up to 12 weeks after last dose of study drugPopulation: Safety population included all participants who had received at least 1 study drug infusion in this study, A4091009 (NCT00399490).
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=281 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Who Discontinued the Study
|
34.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: A4091009: Baseline up to 12 weeks after last dose of study drugPopulation: Safety population included all participants who had received at least 1 study drug infusion in this study, A4091009 (NCT00399490).
Median time of participation in the study for all the participants was evaluated.
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=281 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|---|
|
Median Time in Study A4091009
|
198 days
Interval 1.0 to 484.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of Study (12 weeks after the last dose of study drug)Population: Safety population included all participants who had received at least 1 study drug infusion in this study, A4091009 (NCT00399490). Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row.
HVLT-R: instrument consisting of 12 noun list, used to measure verbal learning and memory (recognition and recall). List was read to participant, who then attempted to recall as many words as possible. The examiner recorded each response. Task was repeated 2 more times, for total of 3 learning trials. After delay interval of 20-25 minutes, delayed recall trial was administered. Total score (TS) = sum of 3 learning trial scores of 12 word each, ranged: 0 (no memory) to 36 (best memory), where higher scores indicated better memory. Delayed recall (DR) = number of words recalled in delayed recall test, ranged: 0 (no memory) to 12 (best memory), where higher scores indicated better memory.
Outcome measures
| Measure |
Tanezumab 50 mcg/kg (Previous Tanezumab Treatment)
n=277 Participants
Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
Tanezumab 50 mcg/kg (Previous Placebo Treatment)
Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|---|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 48: DR
|
0.2 units on a scale
Standard Deviation 1.59
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 56: TS
|
-0.0 units on a scale
Standard Deviation 3.83
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 56: DR
|
0.2 units on a scale
Standard Deviation 1.47
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 64: TS
|
1.1 units on a scale
Standard Deviation 3.81
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 64: DR
|
1.4 units on a scale
Standard Deviation 2.09
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 72: TS
|
1.2 units on a scale
Standard Deviation 4.15
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 72: DR
|
0.2 units on a scale
Standard Deviation 0.45
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at End of Study: TS
|
0.3 units on a scale
Standard Deviation 3.48
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at End of Study: DR
|
0.2 units on a scale
Standard Deviation 1.25
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Baseline: TS
|
31.5 units on a scale
Standard Deviation 3.75
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Baseline: DR
|
11.2 units on a scale
Standard Deviation 1.44
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 4: TS
|
-0.0 units on a scale
Standard Deviation 3.44
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 4: DR
|
-0.0 units on a scale
Standard Deviation 1.16
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 8: TS
|
-0.2 units on a scale
Standard Deviation 3.43
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 8: DR
|
0.1 units on a scale
Standard Deviation 1.45
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 16: TS
|
0.1 units on a scale
Standard Deviation 3.20
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 16: DR
|
0.1 units on a scale
Standard Deviation 1.33
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 24: TS
|
-0.0 units on a scale
Standard Deviation 3.78
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 24: DR
|
0.1 units on a scale
Standard Deviation 1.25
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 32: TS
|
0.6 units on a scale
Standard Deviation 3.53
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 32: DR
|
0.3 units on a scale
Standard Deviation 1.29
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 40: TS
|
1.1 units on a scale
Standard Deviation 3.56
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 40: DR
|
0.4 units on a scale
Standard Deviation 1.27
|
—
|
|
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study
Change at Week 48: TS
|
0.2 units on a scale
Standard Deviation 3.82
|
—
|
Adverse Events
Tanezumab 50 mcg/kg
Serious events: 8 serious events
Other events: 112 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tanezumab 50 mcg/kg
n=281 participants at risk
Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.36%
1/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.36%
1/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.36%
1/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.36%
1/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.36%
1/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
1/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.36%
1/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.36%
1/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Migraine
|
0.36%
1/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.36%
1/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Tanezumab 50 mcg/kg
n=281 participants at risk
Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion.
|
|---|---|
|
General disorders
Oedema peripheral
|
3.6%
10/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
12/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
3.6%
10/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.6%
13/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
3.9%
11/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
7/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
6/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
19/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
17/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
4.6%
13/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.9%
11/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
6/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.8%
8/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
7/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
2.8%
8/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
2.8%
8/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
5.7%
16/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
3.2%
9/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
2.5%
7/281
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER