Tanezumab and Nerve Function In Arthritis Patients

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00863772

Collaborator

(none)

220

Enrollment

Locations

Arms

Actual Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Biological: tanezumab Biological: tanezumab Other: Placebo	Phase 3

Detailed Description

This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Study Design

Study Type:

Interventional

Actual Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY OF TANEZUMAB ON PERIPHERAL NERVE FUNCTION IN PATIENTS WITH OSTEOARTHRITIS.

Actual Study Start Date :

May 18, 2009

Actual Primary Completion Date :

Nov 16, 2010

Actual Study Completion Date :

Nov 16, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tanezumab 5 mg	Biological: tanezumab 5 mg dose Intravenously every 8 weeks for duration of study
Experimental: Tanezumab 10 mg	Biological: tanezumab 10 mg dose Intravenously every 8 weeks for duration of study
Placebo Comparator: Placebo	Other: Placebo Placebo, Intravenously, every 8 weeks for duration of study

Arm

Intervention/Treatment

Experimental: Tanezumab 5 mg

Biological: tanezumab

5 mg dose Intravenously every 8 weeks for duration of study

Experimental: Tanezumab 10 mg

Biological: tanezumab

10 mg dose Intravenously every 8 weeks for duration of study

Placebo Comparator: Placebo

Other: Placebo

Placebo, Intravenously, every 8 weeks for duration of study

Outcome Measures

Primary Outcome Measures

Change From Baseline in 5 Nerve Conduction Tests-Normal Deviate and Heart Rate Deep Breathing-Normal Deviate (5NC [nd] + HRdb [nd]) Composite Score at Week 24: Intent to Treat (ITT) Analysis Set [Baseline, Week 24]
5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency [MNDL],peroneal nerve compound muscle action potential[CMAP],peroneal motor nerve conduction velocity[MNCV],tibial MNDL,sural sensory nerve action potential amplitude [SNAP])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score >0=worse response,less than(<)0=better response compared to normal matched population.Score change>0=worsening,<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values.
Change From Baseline in 5 Nerve Conduction Tests-Normal Deviate and Heart Rate Deep Breathing-Normal Deviate (5NC [nd] + HRdb [nd]) Composite Score at Week 24: Per Protocol Analysis Set (PPAS) [Baseline, Week 24]
5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency [MNDL],peroneal nerve compound muscle action potential[CMAP],peroneal motor nerve conduction velocity[MNCV],tibial MNDL,sural sensory nerve action potential amplitude [SNAP])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score >0=worse response,less than(<)0=better response compared to normal matched population.Score change>0=worsening,<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values.

Secondary Outcome Measures

Change From Baseline in Neuropathy Impairment Score - Lower Limbs [NIS (LL)] at Week 24 [Baseline, Week 24]
NIS-LL: assess muscle weakness, reflexes, sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1 = decreased, or 2 = absent. NIS-LL score: sum of scores of NIS items 17-24, 28-29 and 34-37. Total possible NIS-LL score range 0-88, high score = more impairment.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24 [Baseline, Week 24]
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness are 24 items and scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes and sensation are 13 items and scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0 to 244, higher score = greater impairment.
Change From Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24 [Baseline, Week 24]
NSC score is the number of the 38 symptom questions where the participants indicated experiencing the symptom to any severity. Total score range: 0 to 38 where higher score indicated more symptoms. A change from Baseline > 0 indicated some symptoms of peripheral neuropathy.
Change From Baseline in Peroneal Compound Muscle Action Potential Amplitude (CMAP) Score at Week 24: ITT Analysis Set [Baseline, Week 24]
Peroneal motor nerve compound muscle action potential amplitude (in millivolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score <0 indicated worse response and >0 indicated better response than the normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the two NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Peroneal Compound Muscle Action Potential Amplitude (CMAP) Score at Week 24: PPAS [Baseline, Week 24]
Peroneal motor nerve compound muscle action potential amplitude (in millivolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score <0 indicated worse response and >0 indicated better response than the normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Peroneal Motor Nerve Conduction Velocity (MNCV) Score at Week 24: ITT Analysis Set [Baseline, Week 24]
Peroneal motor nerve conduction velocity (in meters/second) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score <0 indicated worse response and >0 indicated better response than the normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Peroneal Motor Nerve Conduction Velocity (MNCV) Score at Week 24: PPAS [Baseline, Week 24]
Peroneal motor nerve conduction velocity (in meters/second) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score <0 indicated worse response and >0 indicated better response than the normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Peroneal Motor Nerve Distal Latency (MNDL) Score at Week 24: ITT Analysis Set [Baseline, Week 24]
Peroneal motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score >0 indicated worse response and <0 indicated better response as compared to normal matched population. Score change >0 indicated worsening and <0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Peroneal Motor Nerve Distal Latency (MNDL) Score at Week 24: PPAS [Baseline, Week 24]
Peroneal motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score >0 indicated worse response and <0 indicated better response as compared to normal matched population. Score change >0 indicated worsening and <0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Tibial Motor Nerve Distal Latency (MNDL) Score at Week 24: ITT Analysis Set [Baseline, Week 24]
Tibial motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score >0 indicated worse response and <0 indicated better response as compared to normal matched population. Score change >0 indicated worsening and <0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Tibial Motor Nerve Distal Latency (MNDL) Score at Week 24: PPAS [Baseline, Week 24]
Tibial motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score >0 indicated worse response and <0 indicated better response as compared to normal matched population. Score change >0 indicated worsening and <0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Sural Sensory Nerve Action Potential Amplitude (SNAP) Score at Week 24: ITT Analysis Set [Baseline, Week 24]
Sural sensory nerve action potential amplitude (in microvolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. A score <0 indicated worse response and >0 indicated better response than the normal matched population. A change <0 indicated worsening and >0 indicated improvement compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Sural Sensory Nerve Action Potential Amplitude (SNAP) Score at Week 24: PPAS [Baseline, Week 24]
Sural sensory nerve action potential amplitude (in microvolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. A score <0 indicated worse response and >0 indicated better response than the normal matched population. A change <0 indicated worsening and >0 indicated improvement compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Heart Rate Deep Breathing [HRdb] at Week 24: ITT Analysis Set [Baseline, Week 24]
HRdb test was used to evaluate the effect of treatment on autonomic function. Participants took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as a normal deviates. Score <0 indicated worse response and >0 indicated better response as compared to normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Measurements of HRdb were collected twice and highest nd score was selected at each NV. Mean of the 2 selected NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Heart Rate Deep Breathing [HRdb] at Week 24: PPAS [Baseline, Week 24]
HRdb test was used to evaluate the effect of treatment on autonomic function. Participants took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as a normal deviates. Score <0 indicated worse response and >0 indicated better response as compared to normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Measurements of HRdb were collected twice and highest nd score was selected at each NV. Mean of the 2 selected NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in 5 Nerve Conduction Test - Normal Deviate [5NC (nd)] at Week 24: ITT Analysis Set [Baseline, Week 24]
5NC (nd) score included 5 NCS attributes: peroneal MNDL, CMAP, MNCV, tibial MNDL and sural SNAP. Values of attributes scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Total score calculated as sum of each NCS attribute. Total score >0 indicated worse and <0 indicated better response as compared to normal matched population. Total score change >0 indicated worsening and <0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in 5 Nerve Conduction Test - Normal Deviate (5NC [nd]) at Week 24: PPAS [Baseline, Week 24]
5NC (nd) score included 5 NCS attributes: peroneal MNDL, CMAP, MNCV, tibial MNDL and sural SNAP. Values of attributes scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Total score calculated as sum of each NCS attribute. Total score >0 indicated worse and <0 indicated better response as compared to normal matched population. Total score change >0 indicated worsening and <0 indicated improvement as compared to baseline.2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Change From Baseline in Protein Gene Product (PGP) 9.5-Positive Intraepidermal Epidermal Nerve Fiber (IENF) Density at Week 24 [Baseline, Week 24]
IENF density was quantified in 3 millimeter (mm) immunostained (PGP 9.5-immunohistochemical staining) skin punch biopsies taken from the distal end of the leg, 10 centimeter (cm) above the lateral malleolus, within the territory of the sural nerve, containing epidermis and superficial dermis to evaluate amount of small diameter nerve fibers. Skin biopsies were taken from normal appearing skin and skin having local scar, signs of trauma, ulceration, or active dermatologic process were avoided.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 8, 16, and 24 [Baseline, Weeks 8, 16, and 24]
WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 8, 16, and 24 [Baseline, Weeks 8, 16, and 24]
WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function.
Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 8, 16, and 24 [Baseline, Weeks 8, 16, and 24]
Participants answered: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants rated their condition using a 5-point scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response [Weeks 8, 16, and 24]
OMERACT-OARSI response: >=50 percent (%) improvement from baseline and absolute change from baseline of >=2 units in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score [Weeks 8, 16, and 24]
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint ( knee or hip) in the past 48 hours. It is calculated as the mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Percentage of Participants With Improvement of At Least 2 Points From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis [Weeks 8, 16, and 24]
Participants answered: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants rated their condition using a 5-point scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score [Week 16]
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 are reported.
Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24 [Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24]
Participants assessed daily average index joint pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Higher score indicated greater pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 8, 16, and 24 [Baseline, Weeks 8, 16, and 24]
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10, with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 8, 16, and 24 [Baseline, Weeks 8, 16, and 24]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC Pain, Physical Function and Stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response. Change from baseline <0 indicates an improvement.
Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 8, 16, and 24 [Baseline, Weeks 8, 16, and 24]
Participants answered: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain. Change from baseline <0 indicated an improvement.
Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 8, 16, and 24 [Baseline, Weeks 8, 16, and 24]
Participants answered: How much pain have you had when going up or down stairs?. Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain. Change from baseline <0 indicates an improvement.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 [Baseline, Week 24]
SF-36v2 is a self-administered questionnaire evaluating 8 aspects/domains of functional health and wellbeing: physical function, role physical, bodily pain, vitality, general health, social function, role emotional and mental health. The total score for each domain is scaled 0-100 (100 = highest level of functioning). Change from baseline >0 indicates an improvement.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24 [Baseline, Week 24]
SF-36v2 is a self-administered questionnaire evaluating 8 aspects/domains of functional health and wellbeing: physical function, role physical, bodily pain, vitality, general health, social function, role emotional and mental health. Total score for each aspect were scaled 0-100(100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale=(observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Number of Participants With Rescue Medication Usage [Week 8, 16, 24]
In case of inadequate pain relief for osteoarthritis during the treatment period, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.
Number of Days With Rescue Medication Usage [Weeks 8, 16, and 24]
In case of inadequate pain relief for osteoarthritis during the treatment period, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Result reported is number of days of rescue medication use in each week, and ranges from 0 to 7.
Amount of Rescue Medication Used [Weeks 8, 16, and 24]
In case of inadequate pain relief for osteoarthritis during the treatment period, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Results reported is total dose of acetaminophen (in mg) for each week.
Number of Participants With Anti-Drug Antibody (ADA) [pre-dose on Day 1 (Baseline), Week 8, 16, 24, 32]
Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semiquantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.
Plasma Trough Concentration of Tanezumab [pre-dose on Day 1 (Baseline), Weeks 8, 16, 24, and 32]
Plasma trough concentration of tanezumab was measured using a validated, sensitive and specific enzyme-linked immunosorbent assay (ELISA).
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline through 112 days after last Intravenous dose of Investigational product to last participant treated with study medication on study (up to Week 32 after last IV dose of investigational product to last participant treated)]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the 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. AEs included both serious AEs and non-serious AEs.

Other Outcome Measures

Number of Participants With Intravenous Doses of Study Medication [Day 1 up to Week 24]
Number of participants are reported based on the maximum number of intravenous (IV) doses of either tanezumab or placebo received.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI less or equal to 39 kg/m2
Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies
Willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
Patients must consent in writing to participate in the study.

Exclusion Criteria:

Untreated, uncontrolled diseases,
Unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study,
Significant cardiac disease within the past 6 months
Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis, stroke) or signs of neuropathy at screening
Known bleeding disorder or anticoagulation therapy
Planned surgery during the study period
History of alcoholism or drug abuse in the past 2 years
Unable to use acetaminophen
Use of a biologic (including live vaccines, with the exception of Flumist) within the past 3 months
Allergic reaction to a biologic or an antibody in the past
Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.
Medical condition that may interfere with study endpoints or safety of the subject as determined by the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NEA Baptist Clinic	Jonesboro	Arkansas	United States	72401
2	JDP Medical Research, LLC	Aurora	Colorado	United States	80014
3	Alpine Neurology	Centennial	Colorado	United States	80112
4	Peak Anesthesia	Centennial	Colorado	United States	80112
5	JEM Research, LLC	Atlantis	Florida	United States	33462
6	Medical Specialists of the Palm Beaches	Atlantis	Florida	United States	33462
7	Bradenton Research Center, Inc	Bradenton	Florida	United States	34205
8	Manatee Internal Medicine	Bradenton	Florida	United States	34208
9	Clinical Physiology Associates	Fort Myers	Florida	United States	33916
10	Harris Bonnette, MD	Fort Myers	Florida	United States	33919
11	Sunrise Clinical Research, Inc.	Hollywood	Florida	United States	33021
12	Sunrise Clinical Research, Inc	Hollywood	Florida	United States	33024
13	Pharmax Research Clinic, Inc	Miami	Florida	United States	33126
14	International Research Associates, LLC	Miami	Florida	United States	33183
15	The Arthritis Center	Palm Harbor	Florida	United States	34684
16	Pines Neurological Associates	Pembroke Pines	Florida	United States	33026
17	Pembroke Clinical Trials	Pembroke Pines	Florida	United States	33028
18	Pines Neurological Associates	Pembroke Pines	Florida	United States	33028
19	Advent Clinical Research Centers, Inc	Pinellas Park	Florida	United States	33781
20	Advent Clinical Research Center	Pinellas Park	Florida	United States	33781
21	Berma Research Group	Plantation	Florida	United States	33317
22	Carol L. Pappas MD, PhD	Saint Petersburg	Florida	United States	33713
23	Carol L. Pappas, M.D. PhD	Saint Petersburg	Florida	United States	33713
24	Dale G. Bramlet, MD, P.L.	Saint Petersburg	Florida	United States	33713
25	Kennedy-White Orthopaedic Center	Sarasota	Florida	United States	34232
26	Ronal Aung-Din, MD	Sarasota	Florida	United States	34232
27	Ronald Aung-Din, MD	Sarasota	Florida	United States	34232
28	Sarasota Center for Clinical Research	Sarasota	Florida	United States	34232
29	Arthritis & Rheumatic Care Center	South Miami	Florida	United States	33143
30	Miami Research Associates	South Miami	Florida	United States	33143
31	Neuroscience Consultants, LLC	South Miami	Florida	United States	33143
32	Tampa Neurology Associates	Tampa	Florida	United States	33609
33	Tampa Medical Group, P.A.	Tampa	Florida	United States	33614
34	Radiology Associates of Venice & Englewood	Venice	Florida	United States	34285
35	Lovelace Scientific Resources, Inc	Venice	Florida	United States	34292
36	Venice Arthritis Center	Venice	Florida	United States	34292
37	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30308
38	Atlanta Neurology	Atlanta	Georgia	United States	30342
39	Diagnostic Imaging of Atlanta	Atlanta	Georgia	United States	30342
40	NeuroTrials Research, Incorporated	Atlanta	Georgia	United States	30342
41	Northwest Neurology, P.C.	Austell	Georgia	United States	30106
42	Atlanta Knee and Sports Medicine	Decatur	Georgia	United States	30033
43	Joseph D. Weissman, MD	Decatur	Georgia	United States	30033
44	Neurology Specialists of Decatur	Decatur	Georgia	United States	30033
45	Southeastern Center for Clinical Trials	Decatur	Georgia	United States	30033
46	Jefrey D. Lieberman, MD	Decatur	Georgia	United States	30333
47	Northwestern Lake Forest Hospital Diagnostic Imaging Centers	Bannockburn	Illinois	United States	60015
48	Rush University Medical Center	Chicago	Illinois	United States	60612
49	Consultants in Neurology, Ltd.	Northbrook	Illinois	United States	60062
50	Elkhart Clinic, LLC	Elkhart	Indiana	United States	46514
51	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202
52	University Hospital	Indianapolis	Indiana	United States	46202
53	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
54	G. Timothy Kelly, MD	Las Vegas	Nevada	United States	89128
55	Clinical Neurology Specialists	Las Vegas	Nevada	United States	89146
56	Neurological Associates of Long Island, P.C.	Lake Success	New York	United States	11042
57	Andrew J. Porges, M.D. PC	Roslyn	New York	United States	11576
58	Asheville Imaging	Asheville	North Carolina	United States	28801
59	Biltmore Medical Associates	Asheville	North Carolina	United States	28801
60	Clinical Study Center of Asheville, LLC	Asheville	North Carolina	United States	28803
61	Asheville Neurology	Asheville	North Carolina	United States	28806-2287
62	Unifour Medical Research Associates, LLC	Hickory	North Carolina	United States	28601
63	Neurology Associates, PA	Hickory	North Carolina	United States	28602
64	Unifour Medical Research Associates, LLC	Hickory	North Carolina	United States	28602
65	Caldwell Memorial Hospital	Lenoir	North Carolina	United States	28645
66	Northstate Clinical Research	Lenoir	North Carolina	United States	28645
67	Ohio Research Center	Toledo	Ohio	United States	43623
68	Bend Memorial Clinic	Bend	Oregon	United States	97701
69	North Star Neurology	Bend	Oregon	United States	97701
70	Altoona Hospital Campus	Altoona	Pennsylvania	United States	16601
71	Blair Neurologic Associates	Altoona	Pennsylvania	United States	16601
72	Blair Medical Associates	Altoona	Pennsylvania	United States	16602
73	Blair Orthopedic Associates, Inc.	Altoona	Pennsylvania	United States	16602
74	Bon Secour Campus	Altoona	Pennsylvania	United States	16602
75	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
76	Coastal Carolina Research Center in Goose Creek	Goose Creek	South Carolina	United States	29445
77	Tidewater Neurology	Goose Creek	South Carolina	United States	29445
78	AAMR Research Clinic, PA	Amarillo	Texas	United States	79106
79	Amarillo Diagnostic Clinic	Amarillo	Texas	United States	79106
80	Radiant Research, Inc.	Dallas	Texas	United States	75231
81	Dr. Michael Vengrow	Dallas	Texas	United States	75243
82	Foundation for Southwest Orthopedic Research	Houston	Texas	United States	77030
83	The Neurology Center	Houston	Texas	United States	77030
84	Paragon Research Center, LLC	San Antonio	Texas	United States	78205
85	Baptist M&S Imaging	San Antonio	Texas	United States	78215
86	Sun Research Institute	San Antonio	Texas	United States	78215
87	Christine L. Truitt, MD	San Antonio	Texas	United States	78229
88	Diagnostics Research Group	San Antonio	Texas	United States	78229
89	Neurodiagnostic Laboratories of San Antonio, Inc.	San Antonio	Texas	United States	78229
90	Neurodiagnostic Laboratories of San Antonio, Inc	San Antonio	Texas	United States	78229
91	Radiant Research Inc.	San Antonio	Texas	United States	78229
92	IntegraTrials, L.L.C	Arlington	Virginia	United States	22205
93	TLC Neurology, P.L.L.C	Arlington	Virginia	United States	22205
94	Virginia Hospital Center	Arlington	Virginia	United States	22205
95	Hypothe Test, LLC	Roanoke	Virginia	United States	24014
96	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
97	Evergreen Neurology and Neurodiagnostics, PLLC	Everett	Washington	United States	98201

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00863772

Other Study ID Numbers:

A4091026
NERVE SAFETY STUDY

First Posted:

Mar 18, 2009

Last Update Posted:

Feb 4, 2021

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Osteoarthritis

Tanezumab

Study Results

Participant Flow

Recruitment Details	Participants who discontinued due to lack of efficacy or completed the treatment in this study, were eligible to enroll in the safety extension study A4091040 (NCT00960804).
Pre-assignment Detail

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Period Title: Overall Study
STARTED	74	74	72
Treated	73	74	72
COMPLETED	6	9	11
NOT COMPLETED	68	65	61

Baseline Characteristics

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo	Total
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Total of all reporting groups
Overall Participants	73	74	72	219
Age, Customized (Count of Participants)
18 to 44 years	3 4.1%	4 5.4%	11 15.3%	18 8.2%
45 to 64 years	63 86.3%	53 71.6%	50 69.4%	166 75.8%
Greater than or equal to (>=) 65 years	7 9.6%	17 23%	11 15.3%	35 16%
Sex: Female, Male (Count of Participants)
Female	44 60.3%	47 63.5%	39 54.2%	130 59.4%
Male	29 39.7%	27 36.5%	33 45.8%	89 40.6%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in 5 Nerve Conduction Tests-Normal Deviate and Heart Rate Deep Breathing-Normal Deviate (5NC [nd] + HRdb [nd]) Composite Score at Week 24: Intent to Treat (ITT) Analysis Set
Description	5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency [MNDL],peroneal nerve compound muscle action potential[CMAP],peroneal motor nerve conduction velocity[MNCV],tibial MNDL,sural sensory nerve action potential amplitude [SNAP])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score >0=worse response,less than(<)0=better response compared to normal matched population.Score change>0=worsening,<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using last observation carried forward (LOCF) method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	0.61 (2.96)	1.52 (2.50)	0.51 (2.71)
Change at Week 24	0.18 (2.38)	-0.18 (1.73)	-0.15 (2.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg, Placebo
	Comments	Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.434
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares (LS) mean difference
	Estimated Value	0.29
	Confidence Interval	(2-Sided) 95% -0.44 to 1.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.37
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg, Placebo
	Comments	ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.883
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95% -0.68 to 0.79
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.37
	Estimation Comments

2. Primary Outcome

Title	Change From Baseline in 5 Nerve Conduction Tests-Normal Deviate and Heart Rate Deep Breathing-Normal Deviate (5NC [nd] + HRdb [nd]) Composite Score at Week 24: Per Protocol Analysis Set (PPAS)
Description	5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency [MNDL],peroneal nerve compound muscle action potential[CMAP],peroneal motor nerve conduction velocity[MNCV],tibial MNDL,sural sensory nerve action potential amplitude [SNAP])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score >0=worse response,less than(<)0=better response compared to normal matched population.Score change>0=worsening,<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	71	73	71
Baseline	0.45 (2.83)	1.46 (2.46)	0.57 (2.69)
Change at Week 24	0.13 (2.41)	-0.19 (1.74)	-0.11 (2.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 5 mg, Placebo
	Comments	Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.720
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95% -0.59 to 0.86
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.37
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tanezumab 10 mg, Placebo
	Comments	ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value	0.985
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95% -0.73 to 0.74
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.37
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Neuropathy Impairment Score - Lower Limbs [NIS (LL)] at Week 24
Description	NIS-LL: assess muscle weakness, reflexes, sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1 = decreased, or 2 = absent. NIS-LL score: sum of scores of NIS items 17-24, 28-29 and 34-37. Total possible NIS-LL score range 0-88, high score = more impairment.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	0.00 (0.00)	0.08 (0.70)	0.00 (0.00)
Change at Week 24	0.21 (0.92)	0.03 (0.95)	0.06 (0.38)

4. Secondary Outcome

Title	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24
Description	NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness are 24 items and scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes and sensation are 13 items and scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0 to 244, higher score = greater impairment.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	0.00 (0.00)	0.09 (0.81)	0.00 (0.00)
Change at Week 24	0.26 (1.33)	0.07 (1.35)	0.06 (0.38)

5. Secondary Outcome

Title	Change From Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24
Description	NSC score is the number of the 38 symptom questions where the participants indicated experiencing the symptom to any severity. Total score range: 0 to 38 where higher score indicated more symptoms. A change from Baseline > 0 indicated some symptoms of peripheral neuropathy.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)
Change at Week 24	0.31 (1.03)	0.13 (0.57)	0.11 (0.55)

6. Secondary Outcome

Title	Change From Baseline in Peroneal Compound Muscle Action Potential Amplitude (CMAP) Score at Week 24: ITT Analysis Set
Description	Peroneal motor nerve compound muscle action potential amplitude (in millivolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score <0 indicated worse response and >0 indicated better response than the normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the two NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	-0.37 (0.94)	-0.55 (0.85)	-0.09 (0.92)
Change at Week 24	-0.12 (0.65)	-0.11 (0.50)	-0.05 (0.59)

7. Secondary Outcome

Title	Change From Baseline in Peroneal Compound Muscle Action Potential Amplitude (CMAP) Score at Week 24: PPAS
Description	Peroneal motor nerve compound muscle action potential amplitude (in millivolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score <0 indicated worse response and >0 indicated better response than the normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	71	73	71
Baseline	-0.35 (0.94)	-0.55 (0.86)	-0.07 (0.91)
Change at Week 24	-0.10 (0.66)	-0.10 (0.50)	-0.06 (0.59)

8. Secondary Outcome

Title	Change From Baseline in Peroneal Motor Nerve Conduction Velocity (MNCV) Score at Week 24: ITT Analysis Set
Description	Peroneal motor nerve conduction velocity (in meters/second) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score <0 indicated worse response and >0 indicated better response than the normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	0.75 (1.50)	0.22 (1.28)	0.26 (1.52)
Change at Week 24	-0.01 (0.91)	0.12 (1.03)	-0.04 (0.67)

9. Secondary Outcome

Title	Change From Baseline in Peroneal Motor Nerve Conduction Velocity (MNCV) Score at Week 24: PPAS
Description	Peroneal motor nerve conduction velocity (in meters/second) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score <0 indicated worse response and >0 indicated better response than the normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	71	73	71
Baseline	0.76 (1.52)	0.24 (1.28)	0.21 (1.48)
Change at Week 24	-0.01 (0.91)	0.11 (1.04)	-0.04 (0.68)

10. Secondary Outcome

Title	Change From Baseline in Peroneal Motor Nerve Distal Latency (MNDL) Score at Week 24: ITT Analysis Set
Description	Peroneal motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score >0 indicated worse response and <0 indicated better response as compared to normal matched population. Score change >0 indicated worsening and <0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	-0.19 (1.27)	0.01 (1.16)	-0.35 (1.07)
Change at Week 24	-0.03 (0.99)	-0.13 (0.56)	-0.08 (0.77)

11. Secondary Outcome

Title	Change From Baseline in Peroneal Motor Nerve Distal Latency (MNDL) Score at Week 24: PPAS
Description	Peroneal motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score >0 indicated worse response and <0 indicated better response as compared to normal matched population. Score change >0 indicated worsening and <0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	71	73	71
Baseline	-0.24 (1.25)	-0.01 (1.15)	-0.32 (1.05)
Change at Week 24	-0.03 (1.01)	-0.14 (0.57)	-0.07 (0.77)

12. Secondary Outcome

Title	Change From Baseline in Tibial Motor Nerve Distal Latency (MNDL) Score at Week 24: ITT Analysis Set
Description	Tibial motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score >0 indicated worse response and <0 indicated better response as compared to normal matched population. Score change >0 indicated worsening and <0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	0.73 (1.25)	0.90 (1.18)	0.83 (1.09)
Change at Week 24	0.20 (1.08)	-0.16 (0.81)	-0.08 (0.91)

13. Secondary Outcome

Title	Change From Baseline in Tibial Motor Nerve Distal Latency (MNDL) Score at Week 24: PPAS
Description	Tibial motor nerve distal latency (in milliseconds) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Score >0 indicated worse response and <0 indicated better response as compared to normal matched population. Score change >0 indicated worsening and <0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here, 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	71	73	71
Baseline	0.69 (1.24)	0.90 (1.19)	0.82 (1.09)
Change at Week 24	0.20 (1.10)	-0.17 (0.80)	-0.09 (0.92)

14. Secondary Outcome

Title	Change From Baseline in Sural Sensory Nerve Action Potential Amplitude (SNAP) Score at Week 24: ITT Analysis Set
Description	Sural sensory nerve action potential amplitude (in microvolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. A score <0 indicated worse response and >0 indicated better response than the normal matched population. A change <0 indicated worsening and >0 indicated improvement compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	-0.20 (1.12)	-0.06 (1.00)	-0.22 (1.07)
Change at Week 24	-0.03 (0.97)	-0.12 (0.71)	0.01 (0.86)

15. Secondary Outcome

Title	Change From Baseline in Sural Sensory Nerve Action Potential Amplitude (SNAP) Score at Week 24: PPAS
Description	Sural sensory nerve action potential amplitude (in microvolts) was measured using electromyography of the left lower limb. Values were scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. A score <0 indicated worse response and >0 indicated better response than the normal matched population. A change <0 indicated worsening and >0 indicated improvement compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here, 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	71	73	71
Baseline	-0.17 (1.09)	-0.05 (1.00)	-0.25 (1.05)
Change at Week 24	0.01 (0.93)	-0.12 (0.72)	0.03 (0.85)

16. Secondary Outcome

Title	Change From Baseline in Heart Rate Deep Breathing [HRdb] at Week 24: ITT Analysis Set
Description	HRdb test was used to evaluate the effect of treatment on autonomic function. Participants took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as a normal deviates. Score <0 indicated worse response and >0 indicated better response as compared to normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Measurements of HRdb were collected twice and highest nd score was selected at each NV. Mean of the 2 selected NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	-0.25 (0.76)	-0.23 (0.79)	0.01 (1.05)
Change at Week 24	0.06 (0.57)	-0.01 (0.66)	0.02 (0.64)

17. Secondary Outcome

Title	Change From Baseline in Heart Rate Deep Breathing [HRdb] at Week 24: PPAS
Description	HRdb test was used to evaluate the effect of treatment on autonomic function. Participants took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as a normal deviates. Score <0 indicated worse response and >0 indicated better response as compared to normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Measurements of HRdb were collected twice and highest nd score was selected at each NV. Mean of the 2 selected NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	71	73	71
Baseline	-0.23 (0.76)	-0.22 (0.79)	0.04 (1.04)
Change at Week 24	0.05 (0.57)	-0.02 (0.66)	0.02 (0.64)

18. Secondary Outcome

Title	Change From Baseline in 5 Nerve Conduction Test - Normal Deviate [5NC (nd)] at Week 24: ITT Analysis Set
Description	5NC (nd) score included 5 NCS attributes: peroneal MNDL, CMAP, MNCV, tibial MNDL and sural SNAP. Values of attributes scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Total score calculated as sum of each NCS attribute. Total score >0 indicated worse and <0 indicated better response as compared to normal matched population. Total score change >0 indicated worsening and <0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	0.36 (2.86)	1.30 (2.18)	0.53 (2.62)
Change at Week 24	0.34 (2.04)	-0.18 (1.60)	-0.09 (2.03)

19. Secondary Outcome

Title	Change From Baseline in 5 Nerve Conduction Test - Normal Deviate (5NC [nd]) at Week 24: PPAS
Description	5NC (nd) score included 5 NCS attributes: peroneal MNDL, CMAP, MNCV, tibial MNDL and sural SNAP. Values of attributes scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as normal deviate (nd) score based on standard normal distribution. Total score calculated as sum of each NCS attribute. Total score >0 indicated worse and <0 indicated better response as compared to normal matched population. Total score change >0 indicated worsening and <0 indicated improvement as compared to baseline.2 neurological visits (NVs) were conducted both at baseline and Week 24. Mean of the 2 NV measurements was calculated to obtain Baseline and Week 24 values.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
PPAS included all randomized participants who received at least 1 dose of intravenous study medication and excluded those who violated the exclusion criterion "significant signs of neuropathy at baseline visits". Missing values were imputed using LOCF method. Here 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	71	73	71
Baseline	0.22 (2.76)	1.25 (2.15)	0.60 (2.56)
Change at Week 24	0.28 (2.05)	-0.20 (1.60)	-0.09 (2.05)

20. Secondary Outcome

Title	Change From Baseline in Protein Gene Product (PGP) 9.5-Positive Intraepidermal Epidermal Nerve Fiber (IENF) Density at Week 24
Description	IENF density was quantified in 3 millimeter (mm) immunostained (PGP 9.5-immunohistochemical staining) skin punch biopsies taken from the distal end of the leg, 10 centimeter (cm) above the lateral malleolus, within the territory of the sural nerve, containing epidermis and superficial dermis to evaluate amount of small diameter nerve fibers. Skin biopsies were taken from normal appearing skin and skin having local scar, signs of trauma, ulceration, or active dermatologic process were avoided.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values imputed using LOCF. Here 'overall number of participants analyzed' signifies participants evaluable for this measure and 'number analyzed' signifies participants evaluable at specific time points for each arm, respectively.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	71	73	71
Baseline	11.61 (6.33)	11.31 (5.01)	12.43 (6.48)
Change at Week 24	0.31 (4.17)	-0.91 (3.86)	-0.52 (4.15)

21. Secondary Outcome

Title	Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 8, 16, and 24
Description	WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Time Frame	Baseline, Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	5.99 (1.49)	6.45 (1.34)	6.54 (1.55)
Change at Week 8	-2.09 (2.44)	-2.87 (2.82)	-1.12 (1.78)
Change at Week 16	-2.12 (2.22)	-2.56 (2.75)	-1.35 (1.80)
Change at Week 24	-2.06 (2.38)	-2.46 (2.68)	-1.39 (1.85)

22. Secondary Outcome

Title	Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 8, 16, and 24
Description	WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function.
Time Frame	Baseline, Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	6.04 (1.55)	6.19 (1.62)	6.52 (1.70)
Change at Week 8	-1.86 (2.44)	-2.90 (2.74)	-1.03 (1.79)
Change at Week 16	-1.99 (2.37)	-2.61 (2.68)	-1.15 (1.85)
Change at Week 24	-1.97 (2.50)	-2.47 (2.62)	-1.19 (1.82)

23. Secondary Outcome

Title	Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 8, 16, and 24
Description	Participants answered: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants rated their condition using a 5-point scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Time Frame	Baseline, Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	3.29 (0.51)	3.28 (0.45)	3.36 (0.56)
Change at Week 8	-0.70 (0.95)	-0.88 (1.08)	-0.46 (0.80)
Change at Week 16	-0.78 (0.98)	-0.82 (1.06)	-0.56 (0.82)
Change at Week 24	-0.75 (1.00)	-0.74 (1.01)	-0.56 (0.85)

24. Secondary Outcome

Title	Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Description	OMERACT-OARSI response: >=50 percent (%) improvement from baseline and absolute change from baseline of >=2 units in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
Time Frame	Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Week 8	49.3 67.5%	64.9 87.7%	37.5 52.1%
Week 16	52.1 71.4%	62.2 84.1%	40.3 56%
Week 24	52.1 71.4%	59.5 80.4%	38.9 54%

25. Secondary Outcome

Title	Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Description	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint ( knee or hip) in the past 48 hours. It is calculated as the mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
Time Frame	Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Week 8: >=30% Reduction	46.6 63.8%	56.8 76.8%	30.6 42.5%
Week 8: >=50% Reduction	37.0 50.7%	44.6 60.3%	15.3 21.3%
Week 8: >=70% Reduction	26.0 35.6%	32.4 43.8%	5.6 7.8%
Week 8: >=90% Reduction	15.1 20.7%	18.9 25.5%	2.8 3.9%
Week 16: >=30% Reduction	47.9 65.6%	54.1 73.1%	36.1 50.1%
Week 16: >=50% Reduction	39.7 54.4%	39.2 53%	15.3 21.3%
Week 16: >=70% Reduction	24.7 33.8%	27.0 36.5%	9.7 13.5%
Week 16: >=90% Reduction	11.0 15.1%	18.9 25.5%	2.8 3.9%
Week 24: >=30% Reduction	46.6 63.8%	52.7 71.2%	36.1 50.1%
Week 24: >=50% Reduction	35.6 48.8%	37.8 51.1%	20.8 28.9%
Week 24: >=70% Reduction	26.0 35.6%	25.7 34.7%	9.7 13.5%
Week 24: >=90% Reduction	13.7 18.8%	17.6 23.8%	4.2 5.8%

26. Secondary Outcome

Title	Percentage of Participants With Improvement of At Least 2 Points From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis
Description	Participants answered: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants rated their condition using a 5-point scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Time Frame	Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Week 8	19.2 26.3%	31.1 42%	8.3 11.5%
Week 16	21.9 30%	29.7 40.1%	12.5 17.4%
Week 24	21.9 30%	27.0 36.5%	9.7 13.5%

27. Secondary Outcome

Title	Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Description	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 are reported.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
>0%	55 75.3%	50 67.6%	51 70.8%
>=10%	45 61.6%	48 64.9%	39 54.2%
>=20%	39 53.4%	46 62.2%	31 43.1%
>=30%	35 47.9%	40 54.1%	26 36.1%
>=40%	34 46.6%	31 41.9%	21 29.2%
>=50%	29 39.7%	29 39.2%	11 15.3%
>=60%	26 35.6%	24 32.4%	9 12.5%
>=70%	18 24.7%	20 27%	7 9.7%
>=80%	13 17.8%	15 20.3%	4 5.6%
>=90%	8 11%	14 18.9%	2 2.8%
100%	4 5.5%	9 12.2%	0 0%

28. Secondary Outcome

Title	Change From Baseline in Average Pain Score in the Index Knee/Hip Joint at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24
Description	Participants assessed daily average index joint pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Higher score indicated greater pain.
Time Frame	Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 16, 17, 18, 19, 20, 21, 22, 23, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	6.04 (1.73)	6.33 (1.67)	6.45 (1.88)
Change at Week 1	-1.62 (1.80)	-2.04 (1.97)	-0.75 (1.36)
Change at Week 2	-1.88 (2.08)	-2.00 (2.35)	-0.94 (1.81)
Change at Week 3	-1.80 (2.26)	-2.13 (2.67)	-0.99 (1.93)
Change at Week 4	-2.32 (2.26)	-2.92 (2.79)	-1.05 (1.86)
Change at Week 5	-2.46 (2.27)	-2.98 (2.86)	-1.17 (1.87)
Change at Week 6	-2.48 (2.31)	-3.00 (2.88)	-1.21 (1.97)
Change at Week 7	-2.48 (2.36)	-2.97 (3.04)	-1.21 (1.93)
Change at Week 8	-2.46 (2.37)	-2.82 (2.97)	-1.10 (1.81)
Change at Week 9	-2.44 (2.41)	-2.87 (2.93)	-1.12 (1.90)
Change at Week 10	-2.42 (2.36)	-2.77 (2.85)	-1.32 (2.14)
Change at Week 11	-2.33 (2.20)	-2.62 (2.88)	-1.36 (2.12)
Change at Week 12	-2.37 (2.28)	-2.72 (2.87)	-1.32 (2.07)
Change at Week 13	-2.26 (2.26)	-2.81 (2.94)	-1.26 (2.04)
Change at Week 14	-2.35 (2.27)	-2.71 (2.94)	-1.23 (1.88)
Change at Week 15	-2.30 (2.23)	-2.74 (2.91)	-1.19 (1.89)
Change at Week 16	-2.27 (2.20)	-2.62 (2.88)	-1.15 (1.96)
Change at Week 17	-2.33 (2.16)	-2.68 (2.96)	-1.25 (2.07)
Change at Week 18	-2.40 (2.33)	-2.71 (2.95)	-1.20 (2.04)
Change at Week 19	-2.26 (2.18)	-2.73 (2.90)	-1.17 (1.95)
Change at Week 20	-2.32 (2.26)	-2.71 (2.89)	-1.20 (1.88)
Change at Week 21	-2.32 (2.24)	-2.74 (2.91)	-1.24 (1.93)
Change at Week 22	-2.30 (2.18)	-2.71 (2.89)	-1.29 (2.00)
Change at Week 23	-2.30 (2.25)	-2.66 (2.90)	-1.28 (1.97)
Change at Week 24	-2.28 (2.30)	-2.64 (2.90)	-1.20 (1.87)

29. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 8, 16, and 24
Description	The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10, with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).
Time Frame	Baseline, Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	6.38 (1.80)	6.74 (1.62)	6.72 (1.82)
Change at Week 8	-2.14 (2.64)	-3.18 (2.95)	-1.08 (1.92)
Change at Week 16	-2.36 (2.53)	-2.84 (2.90)	-1.22 (1.91)
Change at Week 24	-2.37 (2.66)	-2.70 (2.86)	-1.33 (2.02)

30. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 8, 16, and 24
Description	WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC Pain, Physical Function and Stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response. Change from baseline <0 indicates an improvement.
Time Frame	Baseline, Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	6.14 (1.51)	6.46 (1.40)	6.59 (1.62)
Change at Week 8	-2.03 (2.41)	-2.98 (2.78)	-1.08 (1.73)
Change at Week 16	-2.16 (2.29)	-2.67 (2.71)	-1.24 (1.75)
Change at Week 24	-2.13 (2.44)	-2.54 (2.66)	-1.30 (1.80)

31. Secondary Outcome

Title	Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 8, 16, and 24
Description	Participants answered: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain. Change from baseline <0 indicated an improvement.
Time Frame	Baseline, Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	5.88 (1.55)	6.20 (1.52)	6.47 (1.64)
Change at Week 8	-2.01 (2.51)	-2.74 (2.94)	-1.21 (1.96)
Change at Week 16	-2.04 (2.26)	-2.53 (2.84)	-1.44 (1.98)
Change at Week 24	-1.97 (2.41)	-2.35 (2.75)	-1.38 (1.95)

32. Secondary Outcome

Title	Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 8, 16, and 24
Description	Participants answered: How much pain have you had when going up or down stairs?. Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain. Change from baseline <0 indicates an improvement.
Time Frame	Baseline, Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline	7.16 (1.72)	7.49 (1.30)	7.61 (1.60)
Change at Week 8	-2.30 (2.71)	-3.04 (2.98)	-1.17 (2.05)
Change at Week 16	-2.32 (2.49)	-2.74 (2.94)	-1.21 (2.24)
Change at Week 24	-2.22 (2.67)	-2.64 (2.87)	-1.18 (2.16)

33. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24
Description	SF-36v2 is a self-administered questionnaire evaluating 8 aspects/domains of functional health and wellbeing: physical function, role physical, bodily pain, vitality, general health, social function, role emotional and mental health. The total score for each domain is scaled 0-100 (100 = highest level of functioning). Change from baseline >0 indicates an improvement.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline: General Health	72.22 (14.75)	72.36 (16.39)	70.85 (20.25)
Baseline: Physical Function	38.00 (19.58)	38.58 (18.50)	40.28 (23.19)
Baseline: Role Physical	53.08 (24.81)	49.75 (26.26)	49.57 (27.36)
Baseline: Bodily Pain	39.44 (15.53)	36.36 (14.78)	37.97 (16.49)
Baseline: Vitality	55.74 (19.09)	56.53 (19.50)	57.90 (22.15)
Baseline: Social Function	72.09 (22.68)	75.00 (22.38)	73.96 (25.76)
Baseline: Role Emotional	75.23 (26.89)	74.44 (27.97)	71.64 (27.71)
Baseline: Mental Health	76.78 (16.92)	77.70 (16.90)	76.88 (18.30)
Change at Week 24: General Health	0.44 (8.57)	0.72 (5.56)	-0.28 (7.84)
Change at Week 24: Physical Function	3.72 (12.34)	4.66 (12.34)	3.13 (16.43)
Change at Week 24: Role Physical	1.71 (11.47)	5.74 (15.92)	5.82 (12.60)
Change at Week 24: Bodily Pain	3.25 (13.98)	6.30 (16.98)	4.07 (10.88)
Change at Week 24: Vitality	1.20 (8.82)	2.03 (9.82)	0.52 (6.00)
Change at Week 24: Social Function	0.51 (8.70)	1.86 (15.98)	0.17 (10.38)
Change at Week 24: Role Emotional	-2.05 (13.59)	2.14 (16.09)	3.70 (15.57)
Change at Week 24: Mental Health	0.07 (7.61)	0.95 (10.19)	-0.42 (5.98)

34. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24
Description	SF-36v2 is a self-administered questionnaire evaluating 8 aspects/domains of functional health and wellbeing: physical function, role physical, bodily pain, vitality, general health, social function, role emotional and mental health. Total score for each aspect were scaled 0-100(100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale=(observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
Baseline: Mental Component Score	0.34 (1.09)	0.42 (1.12)	0.32 (1.18)
Baseline: Physical Component Score	-1.54 (0.74)	-1.62 (0.74)	-1.55 (0.82)
Change at Week 24: Mental Component Score	-0.08 (0.48)	0.02 (0.57)	-0.00 (0.44)
Change at Week 24: Physical Component Score	0.16 (0.52)	0.23 (0.55)	0.16 (0.49)

35. Secondary Outcome

Title	Number of Participants With Rescue Medication Usage
Description	In case of inadequate pain relief for osteoarthritis during the treatment period, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.
Time Frame	Week 8, 16, 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	70	71	72
Week 8	25 34.2%	38 51.4%	40 55.6%
Week 16	23 31.5%	28 37.8%	41 56.9%
Week 24	23 31.5%	23 31.1%	36 50%

36. Secondary Outcome

Title	Number of Days With Rescue Medication Usage
Description	In case of inadequate pain relief for osteoarthritis during the treatment period, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Result reported is number of days of rescue medication use in each week, and ranges from 0 to 7.
Time Frame	Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	70	71	72
Week 8	1.0 (1.79)	1.2 (1.64)	1.4 (1.80)
Week 16	0.9 (1.69)	0.8 (1.41)	1.3 (1.80)
Week 24	1.0 (1.85)	0.7 (1.40)	1.4 (1.98)

37. Secondary Outcome

Title	Amount of Rescue Medication Used
Description	In case of inadequate pain relief for osteoarthritis during the treatment period, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Results reported is total dose of acetaminophen (in mg) for each week.
Time Frame	Weeks 8, 16, and 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF method. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	70	71	72
Week 8	1192.9 (2317.7)	1422.5 (2391.4)	2402.8 (3899.8)
Week 16	1128.6 (2270.9)	1028.2 (2253.4)	2222.2 (3608.4)
Week 24	1228.6 (2422.2)	908.5 (2252.5)	2194.4 (3598.3)

38. Secondary Outcome

Title	Number of Participants With Anti-Drug Antibody (ADA)
Description	Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semiquantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.
Time Frame	pre-dose on Day 1 (Baseline), Week 8, 16, 24, 32

Outcome Measure Data

Analysis Population Description
ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure at any time point and 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively. This outcome was not planned to be analyzed for the 'placebo" arm.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	71	70
Baseline	1 1.4%	2 2.7%
Week 8	1 1.4%	0 0%
Week 16	0 0%	0 0%
Week 24	2 2.7%	0 0%
Week 32	0 0%	0 0%

39. Secondary Outcome

Title	Plasma Trough Concentration of Tanezumab
Description	Plasma trough concentration of tanezumab was measured using a validated, sensitive and specific enzyme-linked immunosorbent assay (ELISA).
Time Frame	pre-dose on Day 1 (Baseline), Weeks 8, 16, 24, and 32

Outcome Measure Data

Analysis Population Description
ITT analysis set. Here 'overall number of participants analyzed' signifies participants who were evaluable for this measure at any time point and 'number analyzed' signifies participants who were evaluable at specific time points for each arm, respectively. This outcome was not planned to be analyzed for the 'placebo" arm.

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	65	65
Baseline	84.38 (482.59)	35.68 (176.41)
Week 8	144.2 (95.415)	342.3 (183.27)
Week 16	188.3 (131.70)	554.9 (280.30)
Week 24	63.94 (90.513)	279.5 (422.57)
Week 32	34.15 (53.407)	95.90 (53.859)

40. Other Pre-specified Outcome

Title	Number of Participants With Intravenous Doses of Study Medication
Description	Number of participants are reported based on the maximum number of intravenous (IV) doses of either tanezumab or placebo received.
Time Frame	Day 1 up to Week 24

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
1 dose	41 56.2%	40 54.1%	33 45.8%
2 doses	16 21.9%	16 21.6%	16 22.2%
3 doses	16 21.9%	18 24.3%	23 31.9%

41. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the 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. AEs included both serious AEs and non-serious AEs.
Time Frame	Baseline through 112 days after last Intravenous dose of Investigational product to last participant treated with study medication on study (up to Week 32 after last IV dose of investigational product to last participant treated)

Outcome Measure Data

Analysis Population Description
ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).

Arm/Group Title	Tanezumab 5 mg	Tanezumab 10 mg	Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.	Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
Measure Participants	73	74	72
AEs	41 56.2%	48 64.9%	39 54.2%
SAEs	0 0%	3 4.1%	0 0%

Adverse Events

	Tanezumab 5 mg		Tanezumab 10 mg		Placebo
Time Frame
Adverse Event Reporting Description	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 non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Arm/Group Title	Tanezumab 5 mg		Tanezumab 10 mg		Placebo
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.		Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.		Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes on Day 1, Week 8 and Week 16.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Tanezumab 5 mg		Tanezumab 10 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		3/74 (4.1%)		0/72 (0%)
Gastrointestinal disorders
Abdominal pain lower	0/73 (0%)		1/74 (1.4%)		0/72 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/73 (0%)		1/74 (1.4%)		0/72 (0%)
Lumbar spinal stenosis	0/73 (0%)		1/74 (1.4%)		0/72 (0%)
Nervous system disorders
Syncope	0/73 (0%)		1/74 (1.4%)		0/72 (0%)
Skin and subcutaneous tissue disorders
Pruritus	0/73 (0%)		1/74 (1.4%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	Tanezumab 5 mg		Tanezumab 10 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/73 (49.3%)		39/74 (52.7%)		29/72 (40.3%)
Gastrointestinal disorders
Diarrhoea	1/73 (1.4%)		3/74 (4.1%)		1/72 (1.4%)
Nausea	0/73 (0%)		3/74 (4.1%)		1/72 (1.4%)
Vomiting	0/73 (0%)		3/74 (4.1%)		0/72 (0%)
General disorders
Oedema peripheral	3/73 (4.1%)		6/74 (8.1%)		1/72 (1.4%)
Infections and infestations
Cellulitis	0/73 (0%)		3/74 (4.1%)		1/72 (1.4%)
Upper respiratory tract infection	2/73 (2.7%)		2/74 (2.7%)		1/72 (1.4%)
Urinary tract infection	1/73 (1.4%)		1/74 (1.4%)		2/72 (2.8%)
Injury, poisoning and procedural complications
Fall	0/73 (0%)		3/74 (4.1%)		2/72 (2.8%)
Joint sprain	1/73 (1.4%)		0/74 (0%)		2/72 (2.8%)
Investigations
Bacterial test positive	0/73 (0%)		0/74 (0%)		2/72 (2.8%)
Gamma-glutamyltransferase increased	2/73 (2.7%)		0/74 (0%)		1/72 (1.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	12/73 (16.4%)		15/74 (20.3%)		6/72 (8.3%)
Back pain	2/73 (2.7%)		2/74 (2.7%)		3/72 (4.2%)
Joint swelling	3/73 (4.1%)		3/74 (4.1%)		1/72 (1.4%)
Muscle spasms	2/73 (2.7%)		2/74 (2.7%)		2/72 (2.8%)
Musculoskeletal pain	4/73 (5.5%)		6/74 (8.1%)		2/72 (2.8%)
Myalgia	3/73 (4.1%)		3/74 (4.1%)		0/72 (0%)
Neck pain	0/73 (0%)		2/74 (2.7%)		3/72 (4.2%)
Osteoarthritis	1/73 (1.4%)		3/74 (4.1%)		2/72 (2.8%)
Pain in extremity	7/73 (9.6%)		5/74 (6.8%)		5/72 (6.9%)
Synovial cyst	1/73 (1.4%)		2/74 (2.7%)		0/72 (0%)
Tendonitis	2/73 (2.7%)		4/74 (5.4%)		2/72 (2.8%)
Nervous system disorders
Allodynia	0/73 (0%)		3/74 (4.1%)		0/72 (0%)
Decreased vibratory sense	0/73 (0%)		0/74 (0%)		2/72 (2.8%)
Dysaesthesia	2/73 (2.7%)		0/74 (0%)		0/72 (0%)
Headache	1/73 (1.4%)		3/74 (4.1%)		2/72 (2.8%)
Hyperaesthesia	2/73 (2.7%)		1/74 (1.4%)		0/72 (0%)
Hypoaesthesia	6/73 (8.2%)		4/74 (5.4%)		2/72 (2.8%)
Hyporeflexia	2/73 (2.7%)		0/74 (0%)		0/72 (0%)
Paraesthesia	12/73 (16.4%)		9/74 (12.2%)		2/72 (2.8%)
Sciatica	0/73 (0%)		2/74 (2.7%)		0/72 (0%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion	0/73 (0%)		0/74 (0%)		2/72 (2.8%)
Skin and subcutaneous tissue disorders
Erythema	0/73 (0%)		1/74 (1.4%)		2/72 (2.8%)
Vascular disorders
Hypertension	0/73 (0%)		0/74 (0%)		2/72 (2.8%)

Limitations/Caveats

Due to US FDA imposed clinical hold (effective 23 June 2010), study was terminated early and planned sample size was not achieved. Due to change in planned analysis pre-specified outcome measure 'time to discontinuation due to lack of efficacy' was removed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00863772

Other Study ID Numbers:

A4091026
NERVE SAFETY STUDY

First Posted:

Mar 18, 2009

Last Update Posted:

Feb 4, 2021

Last Verified:

Dec 1, 2020

Tanezumab and Nerve Function In Arthritis Patients

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Other Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

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Certain Agreements

Results Point of Contact