Open-label Extension Study Of RN624

OPEN-LABEL, MULTIPLE-DOSE STUDY OF THE SAFETY AND EFFICACY OF RN624 IN ADULTS WITH PAIN DUE TO OSTEOARTHRITIS OF THE KNEE.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00399490

Enrollment

287

Registered

2006-11-15

Start date

2006-09-15

Completion date

2008-02-11

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, OA Knee Pain, Osteoarthritis

Keywords

Monoclonal antibody

Brief summary

Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.

Interventions

DRUGRN624 (PF-04383119)

50 mcg/kg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Enrolled in Study RN624-CL006

Exclusion criteria

* The occurrence of any adverse event or condition during the controlled studies that, in the opinion of the Investigator, should exclude the subject from participating in the open-label extension * Pregnant or lactating female subjects or subjects who do not agree to use an appropriate form of birth control throughout the study and for 3 months after completing the study

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to 12 weeks after last dose of study drug	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.

Secondary

Measure	Time frame	Description
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	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	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.
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	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	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.
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	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	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.
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	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	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.
Number of Participants With Response to Participant Satisfaction Questionnaire	A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	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.
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	A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	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 .
Percentage of Participants Who Discontinued the Study	A4091009: Baseline up to 12 weeks after last dose of study drug	—
Median Time in Study A4091009	A4091009: Baseline up to 12 weeks after last dose of study drug	Median time of participation in the study for all the participants was evaluated.
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	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.

Other

Measure	Time frame	Description
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	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)	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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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.	281
Total	281

Arm

Count

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.

281

Total

281

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	19
Overall Study	Lack of Efficacy	31
Overall Study	Lost to Follow-up	5
Overall Study	Other	25
Overall Study	Withdrawal by Subject	18

Baseline characteristics

Characteristic	Tanezumab 50 mcg/kg
Age, Continuous	59.3 years STANDARD_DEVIATION 8.1
Sex: Female, Male Female	171 Participants
Sex: Female, Male Male	110 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	112 / 281
serious Total, serious adverse events	8 / 281

Outcome results

Primary

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Time frame: Baseline up to 12 weeks after 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).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tanezumab 50 mcg/kg	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	168 Participants
Tanezumab 50 mcg/kg	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	8 Participants

Secondary

Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

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.

Time frame: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	25.9 units on a scale	Standard Deviation 24.54
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	8.4 units on a scale	Standard Deviation 20.32
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	6.6 units on a scale	Standard Deviation 18.94
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	18.2 units on a scale	Standard Deviation 31.85
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	50.5 units on a scale	Standard Deviation 19.63
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	10.9 units on a scale	Standard Deviation 33.93
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	0.8 units on a scale	Standard Deviation 30.05
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	6.5 units on a scale	Standard Deviation 28.76
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	21.7 units on a scale	Standard Deviation 26.28
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	4.2 units on a scale	Standard Deviation 29.16
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	25.5 units on a scale	Standard Deviation 17.68
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	7.5 units on a scale	Standard Deviation 26.41

Secondary

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

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.

Time frame: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 25.1
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 31.4
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-9.7 units on a scale	Standard Deviation 28.7
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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 11.04
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-27.8 units on a scale	Standard Deviation 23.12
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-22.4 units on a scale	Standard Deviation 22.32
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-39.1 units on a scale	Standard Deviation 21.93
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-28.5 units on a scale	Standard Deviation 24.91
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-34.1 units on a scale	Standard Deviation 24.04
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-16.6 units on a scale	Standard Deviation 24.21
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-28.3 units on a scale	Standard Deviation 5.23
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-37.3 units on a scale	Standard Deviation 21.42
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-26.3 units on a scale	Standard Deviation 23.91
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-34.0 units on a scale	Standard Deviation 22.36

Secondary

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

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.

Time frame: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 23.8
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-21.4 units on a scale	Standard Deviation 4.66
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-40.2 units on a scale	Standard Deviation 20.28
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-7.8 units on a scale	Standard Deviation 28.39
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	67.6 units on a scale	Standard Deviation 13.3
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-34.9 units on a scale	Standard Deviation 23.1
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-38.1 units on a scale	Standard Deviation 23.72
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-33.0 units on a scale	Standard Deviation 23.45
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-27.1 units on a scale	Standard Deviation 23.95
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-30.3 units on a scale	Standard Deviation 22.71
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-23.6 units on a scale	Standard Deviation 23.16
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-22.7 units on a scale	Standard Deviation 20.35
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-15.9 units on a scale	Standard Deviation 22.04

Secondary

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

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.

Time frame: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 27.5
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 26.2
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-8.1 units on a scale	Standard Deviation 33.04
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	71.6 units on a scale	Standard Deviation 13.65
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-26.6 units on a scale	Standard Deviation 24.27
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-17.4 units on a scale	Standard Deviation 24.27
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-22.6 units on a scale	Standard Deviation 20.67
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-42.2 units on a scale	Standard Deviation 21.35
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-33.0 units on a scale	Standard Deviation 26.57
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-36.6 units on a scale	Standard Deviation 25.45
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-19.0 units on a scale	Standard Deviation 14.14
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-39.7 units on a scale	Standard Deviation 23.93
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-26.6 units on a scale	Standard Deviation 24.58
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-34.7 units on a scale	Standard Deviation 24.47

Secondary

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

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.

Time frame: A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 27.3
Tanezumab 50 mcg/kg	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 30.2
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-10.8 units on a scale	Standard Deviation 36.99
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	68.5 units on a scale	Standard Deviation 9.65
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-21.2 units on a scale	Standard Deviation 28.05
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-13.0 units on a scale	Standard Deviation 26.84
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-8.7 units on a scale	Standard Deviation 28.32
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-39.6 units on a scale	Standard Deviation 22.31
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-27.1 units on a scale	Standard Deviation 25.13
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-31.8 units on a scale	Standard Deviation 27.06
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-29.0 units on a scale	Standard Deviation 24.63
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-36.9 units on a scale	Standard Deviation 24.88
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-25.2 units on a scale	Standard Deviation 29.83
Tanezumab 50 mcg/kg (Previous Placebo Treatment)	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	-29.6 units on a scale	Standard Deviation 27.95

Secondary

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

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 .

Time frame: A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 21.4
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 22.9
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 17.1
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 23.4
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 20.5
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 24.7
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 24.9
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 26.5
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 5.1
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 12.5
Tanezumab 50 mcg/kg	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

Median Time in Study A4091009

Median time of participation in the study for all the participants was evaluated.

Time frame: A4091009: Baseline up to 12 weeks after 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).

Arm	Measure	Value (MEDIAN)
Tanezumab 50 mcg/kg	Median Time in Study A4091009	198 days

Secondary

Number of Participants With Response to Participant Satisfaction Questionnaire

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.

Time frame: A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 64: Not at all Satisfied	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 72: A Little Satisfied	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Baseline: Very Satisfied	191 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Baseline: Somewhat Satisfied	36 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Baseline: A Little Satisfied	14 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Baseline: Not at all Satisfied	26 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 4: Very Satisfied	189 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 4: Somewhat Satisfied	57 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 4: A Little Satisfied	11 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 4: Not at all Satisfied	2 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 8: Very Satisfied	204 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 8: Somewhat Satisfied	35 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 8: A Little Satisfied	9 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 8: Not at all Satisfied	3 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 16: Very Satisfied	162 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 16: Somewhat Satisfied	36 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 16: A Little Satisfied	12 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 16: Not at all Satisfied	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 24: Very Satisfied	139 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 24: Somewhat Satisfied	27 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 24: A Little Satisfied	8 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 24: Not at all Satisfied	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 32: Very Satisfied	105 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 32: Somewhat Satisfied	21 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 32: A Little Satisfied	5 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 32: Not at all Satisfied	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 40: Very Satisfied	72 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 40: Somewhat Satisfied	10 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 40: A Little Satisfied	3 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 40: Not at all Satisfied	1 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 48: Very Satisfied	46 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 48: Somewhat Satisfied	7 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 48: A Little Satisfied	3 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 48: Not at all Satisfied	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 56: Very Satisfied	27 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 56: Somewhat Satisfied	3 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 56: A Little Satisfied	2 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 56: Not at all Satisfied	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 64: Very Satisfied	16 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 64: Somewhat Satisfied	2 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 64: A Little Satisfied	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 72: Very Satisfied	4 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 72: Somewhat Satisfied	0 Participants
Tanezumab 50 mcg/kg	Number of Participants With Response to Participant Satisfaction Questionnaire	Week 72: Not at all Satisfied	0 Participants

Secondary

Percentage of Participants Who Discontinued the Study

Time frame: A4091009: Baseline up to 12 weeks after 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).

Arm	Measure	Value (NUMBER)
Tanezumab 50 mcg/kg	Percentage of Participants Who Discontinued the Study	34.9 percentage of participants

Other Pre-specified

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

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.

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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 3.2
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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
Tanezumab 50 mcg/kg	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

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026

Open-label Extension Study Of RN624

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

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Inclusion criteria

Exclusion criteria

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Primary

Secondary

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Participants by arm

Withdrawals & dropouts

Baseline characteristics

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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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 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 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 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 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 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

Median Time in Study A4091009

Number of Participants With Response to Participant Satisfaction Questionnaire

Percentage of Participants Who Discontinued the Study

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