Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01089725
• Collaborator: (none)
• Enrollment: 385
• Locations: 91
• Arms: 5
• Actual Duration (Months): 10.7
• Patients Per Site: 4.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Arthritis; Pain	Biological: Placebo IV; Biological: Placebo SC; Biological: Tanezumab SC; Biological: Placebo IV; Biological: Tanezumab SC; Biological: Placebo IV; Biological: Tanezumab SC; Biological: Placebo IV; Biological: Tanezumab IV; Biological: Placebo SC	Phase 3

Detailed Description

This study was terminated on 08 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: 385 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 THE ANALGESIC EFFICACY AND SAFETY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE.
• Actual Study Start Date: Mar 30, 2010
• Actual Primary Completion Date: Nov 8, 2010
• Actual Study Completion Date: Feb 18, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Biological: Placebo IV; 1 ml of placebo administered SC and IV once every 8 weeks.; Biological: Placebo SC; 1 ml of placebo administered SC and IV once every 8 weeks.
Experimental: 2.5 mg tanezumab SC and placebo IV	Biological: Tanezumab SC; 1 ml tanezumab injection SC administered every 8 weeks; Biological: Placebo IV; 1 ml placebo administered IV every 8 weeks
Experimental: 5 mg tanezumab SC and placebo IV	Biological: Tanezumab SC; 1 ml tanezumab injection SC administered every 8 weeks; Biological: Placebo IV; 1ml placebo administered IV every 8 weeks
Experimental: 10 mg tanezumab SC and placebo IV	Biological: Tanezumab SC; 1 ml tanezumab injection SC administered every 8 weeks; Biological: Placebo IV; 1ml placebo administered IV every 8 weeks
Experimental: 10 mg tanezumab IV	Biological: Tanezumab IV; 1 ml tanezumab injection IV administered every 8 weeks; Biological: Placebo SC; 1ml placebo administered SC every 8 weeks

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 [Baseline, 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 knee 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.

2. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 [Baseline, Week 16]

   The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint 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.

3. Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 [Baseline, Week 16]

   Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by 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.

Secondary Outcome Measures

1. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 [Baseline, Weeks 1, 2, 4, 8, and 12]

   The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee 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.

2. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 [Baseline, Weeks 1, 2, 4, 8, and 12]

   The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint 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.

3. Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 [Baseline, Weeks 1, 2, 4, 8, and 12]

   Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by 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.

4. Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response [Weeks 1, 2, 4, 8, 12, and 16]

   The OMERACT-OARSI responder index is based on 3 parameters. OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at week of interest 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 at week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score range: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score range: 0-10, higher score=higher pain/difficulty).

5. 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 1, 2, 4, 8, 12, and 16]

   The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee 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.

6. Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 [Weeks 1, 2, 4, 8, 12, 16]

   The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a 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.

7. Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis [Weeks 1, 2, 4, 8, 12, and 16]

   Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by 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. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value.

8. Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 [Baseline, Weeks 1, 2, 4, 8, 12, and 16]

   Participants assessed average osteoarthritis pain in their knee in the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Higher score indicated greater pain. Baseline score was calculated as the mean of the scores over the 3 days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores within each study week.

9. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 [Baseline, Weeks 1, 2, 4, 8, 12, and 16]

   The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced in the index joint 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 is defined as a sensation of decreased ease in movement of the knee.

10. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 [Baseline, Weeks 1, 2, 4, 8, 12, and 16]

    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. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores. WOMAC pain, physical function and stiffness subscale and average score ranges from 0 to 10, where higher score indicates worse response.

11. Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 1, 2, 4, 8, 12, and 16 [Baseline, Weeks 1, 2, 4, 8, 12, and 16]

    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.

12. Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 1, 2, 4, 8, 12, and 16 [Baseline, Weeks 1, 2, 4, 8, 12, and 16]

    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.

13. Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 [Baseline, Week 16]

    SF-36v2 is a standardized self-administered survey evaluating 8 aspects/domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The total score for each domain is scaled 0-100 (100 = highest level of functioning).

14. Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 [Baseline, Week 16]

    SF-36v2: standardized self-administered survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, 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.

15. Time to Discontinuation Due to Lack of Efficacy [Baseline up to Week 24]

    Median time to discontinuation due to lack of efficacy for participants who discontinued due to lack of efficacy was reported.

16. Percentage of Participants Who Used Rescue Medication [Weeks 1, 2, 4, 8, 12, and 16]

    In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Incidence of rescue medication use is calculated as any use of rescue medication during the study week in question.

17. Duration of Rescue Medication Use [Weeks 1, 2, 4, 8, 12, and 16]

    In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Duration of rescue medication use is calculated as the number of study days per week when any rescue medication was taken.

18. Amount of Rescue Medication Taken [Weeks 1, 2, 4, 8, 12, and 16]

    In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. The amount of rescue medication taken is the total dose (in mg) of acetaminophen rescue medication over the study week in question.

Other Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 112 days after last dose of study treatment]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

2. Number of Participants With Abnormal Laboratory Findings [Day 1 up to Week 24]

   Laboratory examination included blood chemistry, hematology and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.

3. Number of Participants With Abnormal Electrocardiogram (ECG) Findings [Baseline up to Week 24]

   Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate (HR). Number of participants with clinically significant abnormal ECG findings reported as adverse events were presented.

4. Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 [Baseline, Weeks 2, 4, 8, 12, 16, and 24]

   The NIS constitutes the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) are scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score range 0-244 with higher score = more impairment.

5. Number of Participants With Anti-drug Antibodies (ADA) [Baseline, Weeks 8, 16, 24 or Early Termination]

   Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.

6. Number of Participants With Abnormal Physical Examination Findings [Baseline up to Week 24]

   Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat, lungs and thyroid.

7. Number of Participants With Clinically Significant Abnormality in Vital Signs [Baseline to Week 24]

   Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, pulse rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs reported as adverse events were presented.

8. Number of Participants With Injection and Infusion Site Reactions [Baseline, Weeks 1, 2, 4, 8, 12, 16, and 24]

   The injection and infusion site reactions were assessed based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after administration of subcutaneous injection or intravenous infusion.

9. Plasma Tanezumab Concentration [Baseline (pre-dose), Weeks 1, 2, 4, 8 (pre-dose), 12, 16, 24 or End of treatment]

10. Total and Free Nerve Growth Factor (NGF) Concentration [Baseline (pre-dose), Weeks 1, 2, 4, 8 (pre-dose), 12, 16, and 24 or End of treatment]

    Serum samples were analyzed for determining total and free (unbound) NGF concentration. Total NGF was analyzed using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method and free (unbound) NGF was analyzed using a validated, sensitive, and specific electrochemiluminescence (ECL) ligand binding assay.

11. Number of Participants With Intravenous or Subcutaneous Doses of Study Medication [Baseline up to Week 8]

    Number of participants were reported based on the maximum number of intravenous or subcutaneous 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: No

Inclusion Criteria:

• Diagnosis of osteoarthritis (OA) of the knee according to American College of Rheumatology (ACR) criteria with a Kellgren- Lawrence score of greater than or equal to 2

• 18 years of age or greater

• Two methods of birth control one of which must be barrier if of childbearing potential

• Willing to discontinue pain medication except as permitted per protocol

Exclusion Criteria:

• Pregnancy or wishing to be pregnant during the course of the study, lactating women

• Body Mass Index (BMI) greater than 39

• Clinically significant cardiac, neurological, psychiatric conditions and other conditions that are excluded by the protocol.

• Previous exposure to a Nerve Growth Factor (NGF) antibody

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vaughn H. Mancha, Jr., MD, PC	Montgomery	Alabama	United States	36117
2	Novara Clinical Research	Mesa	Arizona	United States	85206
3	Redpoint Research	Phoenix	Arizona	United States	85029
4	Advanced Clinical Research Institute	Anaheim	California	United States	92801
5	West Coast Radiology Center	Anaheim	California	United States	92801
6	Providence Clinical Research	Burbank	California	United States	91505
7	Valley Research	Fresno	California	United States	93720
8	Allergy and Rheumatology Medical Clinic, Inc.	La Jolla	California	United States	92037-1233
9	Triwest Research Associates	La Mesa	California	United States	91942
10	Synergy Clinical Research Center	National City	California	United States	91950
11	Benchmark Research	Sacramento	California	United States	95816
12	Probe Clinical Research Corp.	Santa Ana	California	United States	92701
13	Trinity Clinical Trials	Santa Ana	California	United States	92701
14	FMC Clinical Trials	Upland	California	United States	91786
15	Colorado Hematology	Englewood	Colorado	United States	80110
16	Colorado Orthopedic Consultants, P.C.	Englewood	Colorado	United States	80110
17	Stamford Therapeutics Consortium	Stamford	Connecticut	United States	06905
18	Office of Cynthia Morgan, MD	Washington	District of Columbia	United States	20003
19	Innovative Research of West Florida, Inc.	Clearwater	Florida	United States	33756
20	Nature Coast Clinical Research	Crystal River	Florida	United States	34429
21	Fleming Island Center for Clinical Research	Fleming Island	Florida	United States	32003
22	Westside Center for Clinical Research	Jacksonville	Florida	United States	32205
23	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
24	BayCare Outpatient Imaging at Bardmoor	Largo	Florida	United States	33777
25	Sunshine Research Center	Opa-locka	Florida	United States	33054
26	DMI Research, Inc.	Pinellas Park	Florida	United States	33782
27	St. Petersburg Arthritis Center	Saint Petersburg	Florida	United States	33710
28	North Georgia Clinical Research	Woodstock	Georgia	United States	30189
29	North Georgia Internal Medicine	Woodstock	Georgia	United States	30189
30	East-West Medical Research Institute	Honolulu	Hawaii	United States	96814
31	Sonoma Clinical Research, LLC.	Boise	Idaho	United States	83702
32	Sonora Clinical Research	Boise	Idaho	United States	83702
33	Apex Medical Research, AMR, Inc.	Chicago	Illinois	United States	60616
34	Professional Research Network of Kansas, LLC	Wichita	Kansas	United States	67203
35	Wichita Clinic PA	Wichita	Kansas	United States	67208
36	Bluegrass Community Research, Inc.	Lexington	Kentucky	United States	40504
37	BenchMark Research	Metairie	Louisiana	United States	70006
38	Arthritis Treatment Center	Frederick	Maryland	United States	21702
39	The Center for Rheumatology and Bone Research	Wheaton	Maryland	United States	20902
40	Beacon Clinical Research, LLC	Brockton	Massachusetts	United States	02301
41	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01610
42	Ann Arbor Clinical Reserch	Ann Arbor	Michigan	United States	48103
43	Troy Internal Medicine, PC	Troy	Michigan	United States	48098
44	Arthritis Associates, PLLC	Hattiesburg	Mississippi	United States	39402
45	Billings Clinic Infusion Center	Billings	Montana	United States	59101
46	Billings Clinic Research Center	Billings	Montana	United States	59101
47	Physician Research Collaboration, LLC	Lincoln	Nebraska	United States	68516
48	Midwest Minor Medical	Omaha	Nebraska	United States	68114
49	Quality Clinical Research, Inc.	Omaha	Nebraska	United States	68114
50	Midwest Minor Medical	Omaha	Nebraska	United States	68127
51	Midwest Minor Medical	Omaha	Nebraska	United States	68144
52	G. Timothy Kelly, MD	Las Vegas	Nevada	United States	89128
53	Andrew Porges, MD, PC	Roslyn	New York	United States	11576
54	PMG Research of Charlotte	Charlotte	North Carolina	United States	28209-3734
55	Greensboro Imaging	Greensboro	North Carolina	United States	27407
56	Pharmquest	Greensboro	North Carolina	United States	27408
57	Wake Internal Medicine Consultants, Inc.	Raleigh	North Carolina	United States	27612
58	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
59	Community Research	Cincinnati	Ohio	United States	45245
60	Sterling Research Group, Ltd.	Cincinnati	Ohio	United States	45246
61	LION Research	Norman	Oklahoma	United States	73069
62	McBride Clinic	Norman	Oklahoma	United States	73072
63	Health Research Institute	Oklahoma City	Oklahoma	United States	73109
64	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
65	Lebanon Internal Medicine Associates	Lebanon	Pennsylvania	United States	17042
66	Founders Research Corporation	Philadelphia	Pennsylvania	United States	19152
67	Clinical Research Center of Reading, LLP	Wyomissing	Pennsylvania	United States	19610
68	Coastal Carolina Research Center	Mount Pleasant	South Carolina	United States	29464
69	Health Concepts	Rapid City	South Dakota	United States	57702
70	SoFHA Clinical Research	Johnson City	Tennessee	United States	37604
71	FutureSearch Trials of Neurology	Austin	Texas	United States	78731
72	Tekton Research, Inc.	Austin	Texas	United States	78745
73	Tekton Research, Inc	Austin	Texas	United States	78745
74	Westbury Medical Clinic	Houston	Texas	United States	77005
75	Asif Cochinwala, MD, P.A.	Houston	Texas	United States	77008
76	Accurate Clinical Research	Houston	Texas	United States	77034
77	Mercury Clinical Research	Houston	Texas	United States	77036
78	Pioneer Research Solutions, Inc	Houston	Texas	United States	77036
79	Clinical Trial Network	Houston	Texas	United States	77074
80	Houston Institute for Clinical Research	Houston	Texas	United States	77074
81	Little York Medical Center	Houston	Texas	United States	77093
82	Internist Associates of Texas	Kingwood	Texas	United States	77339
83	Accurate Clinical Research Inc	Nassau Bay	Texas	United States	77058
84	Clinical Investigations of Texas, LLC	Plano	Texas	United States	75075
85	Benchmark Research	San Angelo	Texas	United States	76904
86	Pioneer Research Solutions, Inc	Sugar Land	Texas	United States	77479
87	Grayline Clinical Drug Trials	Wichita Falls	Texas	United States	76309
88	Advanced Clinical Research	West Jordan	Utah	United States	84088
89	Charlottesville Medical Research	Charlottesville	Virginia	United States	22911
90	Hypothe Test, LLC	Roanoke	Virginia	United States	24018
91	Mountain State Clinical Research	Clarksburg	West Virginia	United States	26301

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: NCT01089725
• Other Study ID Numbers: A4091027; SC/IV OA STUDY
• First Posted: Mar 18, 2010
• Last Update Posted: May 5, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Pfizer: safety; efficacy; parallel group; double-blind; multicenter; injection; infusion; osteoarthritis; bridging; subcutaneous; intravenous; tanezumab
• Additional relevant MeSH terms: Osteoarthritis; Tanezumab

Study Results

Participant Flow

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Period Title: Overall Study
STARTED	72	75	65	87	86
Treated	72	74	63	86	84
COMPLETED	6	7	4	8	6
NOT COMPLETED	66	68	61	79	80

Baseline Characteristics

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion	Total
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.	Total of all reporting groups
Overall Participants	72	74	63	86	84	379
Age, Customized (Count of Participants)
18 to 44 years	8 11.1%	3 4.1%	7 11.1%	4 4.7%	3 3.6%	25 6.6%
45 to 64 years	38 52.8%	48 64.9%	32 50.8%	62 72.1%	56 66.7%	236 62.3%
Greater than or equal to (>=) 65 years	26 36.1%	23 31.1%	24 38.1%	20 23.3%	25 29.8%	118 31.1%
Sex: Female, Male (Count of Participants)
Female	47 65.3%	48 64.9%	36 57.1%	54 62.8%	48 57.1%	233 61.5%
Male	25 34.7%	26 35.1%	27 42.9%	32 37.2%	36 42.9%	146 38.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16
Description	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee 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, Week 16

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Last observation carried forward (LOCF) method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
Baseline	7.31 (1.41)	7.70 (1.46)	7.48 (1.43)	7.51 (1.29)	7.24 (1.37)
Change at Week 16	-2.79 (2.14)	-3.84 (2.79)	-3.77 (2.62)	-3.88 (2.72)	-3.63 (2.41)

2. Primary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16
Description	The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint 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, Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	83
Baseline	6.99 (1.67)	7.25 (1.60)	7.03 (1.64)	7.12 (1.42)	6.75 (1.42)
Change at Week 16	-2.29 (2.02)	-3.28 (2.89)	-3.22 (2.49)	-3.51 (2.57)	-3.18 (2.28)

3. Primary Outcome

Title	Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16
Description	Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by 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, Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	83
Baseline	3.47 (0.63)	3.43 (0.64)	3.43 (0.61)	3.49 (0.65)	3.30 (0.51)
Change at Week 16	-0.81 (0.87)	-1.03 (1.02)	-0.92 (0.92)	-1.08 (1.10)	-0.92 (0.97)

4. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12
Description	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee 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 1, 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
Change at Week 1	-2.15 (2.25)	-3.06 (2.47)	-2.67 (2.56)	-3.27 (2.49)	-3.41 (2.76)
Change at Week 2	-2.46 (2.28)	-3.76 (2.69)	-3.23 (2.70)	-3.19 (2.67)	-2.59 (2.64)
Change at Week 4	-2.74 (2.20)	-4.15 (2.72)	-3.63 (2.59)	-3.89 (2.83)	-3.58 (2.47)
Change at Week 8	-2.74 (2.09)	-3.89 (2.76)	-3.80 (2.64)	-3.89 (2.73)	-3.59 (2.38)
Change at Week 12	-2.81 (2.13)	-3.87 (2.76)	-3.81 (2.67)	-3.88 (2.72)	-3.62 (2.42)

5. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12
Description	The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint 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 1, 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	83
Change at Week 1	-1.75 (2.24)	-2.78 (2.49)	-2.22 (2.26)	-2.99 (2.30)	-2.99 (2.46)
Change at Week 2	-1.97 (2.08)	-3.27 (2.73)	-2.89 (2.57)	-3.01 (2.46)	-2.45 (2.36)
Change at Week 4	-2.21 (2.07)	-3.55 (2.81)	-3.20 (2.52)	-3.57 (2.53)	-3.17 (2.31)
Change at Week 8	-2.26 (2.01)	-3.31 (2.86)	-3.28 (2.53)	-3.51 (2.58)	-3.13 (2.25)
Change at Week 12	-2.31 (2.02)	-3.29 (2.87)	-3.27 (2.55)	-3.50 (2.58)	-3.16 (2.29)

6. Secondary Outcome

Title	Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12
Description	Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by 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 1, 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	83
Change at Week 1	-0.57 (0.82)	-0.82 (0.94)	-0.75 (0.86)	-0.87 (0.85)	-0.88 (1.04)
Change at Week 2	-0.67 (0.86)	-0.93 (1.05)	-0.83 (0.89)	-0.94 (1.01)	-0.58 (0.93)
Change at Week 4	-0.76 (0.76)	-1.12 (1.03)	-1.02 (0.92)	-1.03 (1.10)	-0.88 (0.90)
Change at Week 8	-0.78 (0.83)	-1.07 (1.00)	0.95 (0.92)	-1.08 (1.10)	-0.90 (0.96)
Change at Week 12	-0.81 (0.87)	-1.05 (0.99)	-0.94 (0.93)	-1.08 (1.10)	-0.92 (0.97)

7. Secondary Outcome

Title	Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Description	The OMERACT-OARSI responder index is based on 3 parameters. OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at week of interest 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 at week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score range: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score range: 0-10, higher score=higher pain/difficulty).
Time Frame	Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
Week 1	41.7 57.9%	68.9 93.1%	58.7 93.2%	68.6 79.8%	64.3 76.5%
Week 2	54.2 75.3%	68.9 93.1%	68.3 108.4%	64.0 74.4%	59.5 70.8%
Week 4	63.9 88.8%	78.4 105.9%	74.6 118.4%	72.1 83.8%	73.8 87.9%
Week 8	59.7 82.9%	74.3 100.4%	74.6 118.4%	79.1 92%	76.2 90.7%
Week 12	61.1 84.9%	74.3 100.4%	74.6 118.4%	79.1 92%	76.2 90.7%
Week 16	61.1 84.9%	74.3 100.4%	74.6 118.4%	79.1 92%	76.2 90.7%

8. 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 knee 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	Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
Week 1: >=30% reduction	36.1 50.1%	54.1 73.1%	49.2 78.1%	65.1 75.7%	64.3 76.5%
Week 1: >=50% reduction	25.0 34.7%	40.5 54.7%	33.3 52.9%	45.3 52.7%	51.2 61%
Week 1: >=70% reduction	13.9 19.3%	23.0 31.1%	23.8 37.8%	27.9 32.4%	33.3 39.6%
Week 1: >=90% reduction	8.3 11.5%	9.5 12.8%	11.1 17.6%	5.8 6.7%	14.3 17%
Week 2: >=30% reduction	48.6 67.5%	63.5 85.8%	57.1 90.6%	61.6 71.6%	54.8 65.2%
Week 2: >=50% reduction	30.6 42.5%	52.7 71.2%	44.4 70.5%	38.4 44.7%	39.3 46.8%
Week 2: >=70% reduction	18.1 25.1%	36.5 49.3%	30.2 47.9%	27.9 32.4%	20.2 24%
Week 2: >=90% reduction	8.3 11.5%	17.6 23.8%	15.9 25.2%	14.0 16.3%	6.0 7.1%
Week 4: >=30% reduction	56.9 79%	66.2 89.5%	65.1 103.3%	66.3 77.1%	66.7 79.4%
Week 4: >=50% reduction	31.9 44.3%	55.4 74.9%	54.0 85.7%	53.5 62.2%	53.6 63.8%
Week 4: >=70% reduction	19.4 26.9%	44.6 60.3%	34.9 55.4%	43.0 50%	32.1 38.2%
Week 4: >=90% reduction	5.6 7.8%	27.0 36.5%	19.0 30.2%	16.3 19%	13.1 15.6%
Week 8: >=30% reduction	59.7 82.9%	62.2 84.1%	68.3 108.4%	69.8 81.2%	71.4 85%
Week 8: >=50% reduction	33.3 46.3%	47.3 63.9%	57.1 90.6%	53.5 62.2%	51.2 61%
Week 8: >=70% reduction	16.7 23.2%	40.5 54.7%	42.9 68.1%	38.4 44.7%	29.8 35.5%
Week 8: >=90% reduction	4.2 5.8%	24.3 32.8%	19.0 30.2%	15.1 17.6%	16.7 19.9%
Week 12: >=30% reduction	61.1 84.9%	62.2 84.1%	68.3 108.4%	69.8 81.2%	70.2 83.6%
Week 12: >=50% reduction	34.7 48.2%	45.9 62%	57.1 90.6%	53.5 62.2%	51.2 61%
Week 12: >=70% reduction	18.1 25.1%	40.5 54.7%	42.9 68.1%	38.4 44.7%	31.0 36.9%
Week 12: >=90% reduction	4.2 5.8%	24.3 32.8%	19.0 30.2%	14.0 16.3%	17.9 21.3%
Week 16: >=30% reduction	61.1 84.9%	60.8 82.2%	68.3 108.4%	69.8 81.2%	70.2 83.6%
Week 16: >=50% reduction	33.3 46.3%	45.9 62%	57.1 90.6%	53.5 62.2%	52.4 62.4%
Week 16: >=70% reduction	18.1 25.1%	40.5 54.7%	41.3 65.6%	38.4 44.7%	31.0 36.9%
Week 16: >=90% reduction	4.2 5.8%	24.3 32.8%	17.5 27.8%	14.0 16.3%	17.9 21.3%

9. Secondary Outcome

Title	Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score at Weeks 1, 2, 4, 8, 12, and 16
Description	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a 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	Weeks 1, 2, 4, 8, 12, 16

Outcome Measure Data

Analysis Population Description

ITT population. LOCF method was used to impute missing values. Results for Week 1, 2, 4, 8 and 12 were not reported because analysis was not performed as per change in planned analysis.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
Week 16: Greater than 0% reduction	63 87.5%	69 93.2%	57 90.5%	77 89.5%	78 92.9%
Week 16: >=10% reduction	57 79.2%	64 86.5%	53 84.1%	72 83.7%	73 86.9%
Week 16: >=20% reduction	50 69.4%	56 75.7%	47 74.6%	65 75.6%	65 77.4%
Week 16: >=30% reduction	44 61.1%	45 60.8%	43 68.3%	60 69.8%	59 70.2%
Week 16: >=40% reduction	32 44.4%	40 54.1%	39 61.9%	54 62.8%	52 61.9%
Week 16: >=50% reduction	24 33.3%	34 45.9%	36 57.1%	46 53.5%	44 52.4%
Week 16: >=60% reduction	21 29.2%	30 40.5%	29 46%	42 48.8%	34 40.5%
Week 16: >=70% reduction	13 18.1%	30 40.5%	26 41.3%	33 38.4%	26 31%
Week 16: >=80% reduction	11 15.3%	24 32.4%	17 27%	22 25.6%	21 25%
Week 16: >=90% reduction	3 4.2%	18 24.3%	11 17.5%	12 14%	15 17.9%
Week 16: 100% reduction	1 1.4%	8 10.8%	3 4.8%	5 5.8%	8 9.5%

10. Secondary Outcome

Title	Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
Description	Participants answered the question: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?" Participants responded by 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. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value.
Time Frame	Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
Week 1	11 15.3%	17 23%	12 19%	21 24.4%	24 28.6%
Week 2	10 13.9%	23 31.1%	15 23.8%	23 26.7%	10 11.9%
Week 4	9 12.5%	24 32.4%	20 31.7%	25 29.1%	18 21.4%
Week 8	13 18.1%	22 29.7%	16 25.4%	27 31.4%	23 27.4%
Week 12	14 19.4%	21 28.4%	16 25.4%	27 31.4%	24 28.6%
Week 16	14 19.4%	21 28.4%	15 23.8%	27 31.4%	24 28.6%

11. Secondary Outcome

Title	Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16
Description	Participants assessed average osteoarthritis pain in their knee in the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Higher score indicated greater pain. Baseline score was calculated as the mean of the scores over the 3 days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores within each study week.
Time Frame	Baseline, Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' included those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	70	74	62	85	84
Baseline	7.12 (1.75)	6.96 (1.97)	6.72 (2.10)	6.93 (1.76)	6.44 (1.88)
Change at Week 1	-1.17 (1.93)	-1.36 (1.69)	-1.27 (1.73)	-1.93 (1.99)	-1.82 (1.96)
Change at Week 2	-1.74 (2.27)	-2.54 (2.25)	-2.23 (2.33)	-2.47 (2.62)	-1.78 (2.17)
Change at Week 4	-2.10 (2.30)	-2.85 (2.35)	-2.95 (2.41)	-3.12 (2.73)	-2.37 (2.25)
Change at Week 8	-2.27 (2.60)	-2.55 (2.47)	-2.85 (2.26)	-3.01 (2.63)	-2.34 (2.34)
Change at Week 12	-2.32 (2.59)	-2.48 (2.44)	-3.00 (2.43)	-3.00 (2.68)	-2.34 (2.29)
Change at Week 16	-2.33 (2.59)	-2.49 (2.45)	-2.93 (2.39)	-2.97 (2.65)	-2.33 (2.29)

12. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16
Description	The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced in the index joint 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 is defined as a sensation of decreased ease in movement of the knee.
Time Frame	Baseline, Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
Baseline	7.19 (1.78)	7.33 (2.20)	7.26 (1.73)	7.41 (1.59)	6.99 (1.85)
Change at Week 1	-1.75 (1.92)	-2.78 (2.65)	-2.40 (2.44)	-3.18 (2.65)	-3.24 (2.70)
Change at Week 2	-2.05 (2.11)	-3.38 (2.81)	-3.10 (2.71)	-3.38 (2.74)	-2.64 (2.61)
Change at Week 4	-2.17 (2.19)	-3.61 (3.05)	-3.52 (2.70)	-3.85 (2.82)	-3.38 (2.72)
Change at Week 8	-2.15 (2.04)	-3.32 (3.18)	-3.52 (2.68)	-3.87 (2.89)	-3.32 (2.66)
Change at Week 12	-2.19 (2.03)	-3.30 (3.19)	-3.52 (2.69)	-3.86 (2.87)	-3.36 (2.71)
Change at Week 16	-2.17 (2.03)	-3.30 (3.20)	-3.47 (2.64)	-3.87 (2.87)	-3.37 (2.69)

13. Secondary Outcome

Title	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16
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. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores. WOMAC pain, physical function and stiffness subscale and average score ranges from 0 to 10, where higher score indicates worse response.
Time Frame	Baseline, Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
Baseline	7.17 (1.44)	7.43 (1.58)	7.26 (1.44)	7.35 (1.27)	6.99 (1.30)
Change at Week 1	-1.88 (2.04)	-2.89 (2.36)	-2.43 (2.25)	-3.15 (2.37)	-3.21 (2.48)
Change at Week 2	-2.18 (2.01)	-3.48 (2.59)	-3.07 (2.55)	-3.19 (2.50)	-2.56 (2.37)
Change at Week 4	-2.39 (2.00)	-3.78 (2.72)	-3.46 (2.49)	-3.77 (2.60)	-3.37 (2.36)
Change at Week 8	-2.40 (1.88)	-3.52 (2.79)	-3.54 (2.50)	-3.76 (2.59)	-3.34 (2.27)
Change at Week 12	-2.45 (1.90)	-3.50 (2.79)	-3.54 (2.53)	-3.75 (2.58)	-3.38 (2.31)
Change at Week 16	-2.44 (1.90)	-3.49 (2.81)	-3.49 (2.47)	-3.75 (2.58)	-3.39 (2.30)

14. Secondary Outcome

Title	Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 1, 2, 4, 8, 12, and 16
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.
Time Frame	Baseline, Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
Baseline	7.28 (1.69)	7.73 (1.74)	7.43 (1.71)	7.41 (1.58)	7.24 (1.68)
Change at Week 1	-2.01 (2.76)	-3.14 (2.54)	-2.67 (2.74)	-3.30 (2.67)	-3.40 (2.83)
Change at Week 2	-2.40 (2.75)	-3.82 (2.82)	-3.29 (2.77)	-3.26 (2.81)	-2.75 (2.82)
Change at Week 4	-2.68 (2.63)	-4.20 (2.94)	-3.60 (2.67)	-3.91 (2.89)	-3.64 (2.56)
Change at Week 8	-2.51 (2.49)	-4.01 (2.94)	-3.84 (2.71)	-3.85 (2.85)	-3.62 (2.50)
Change at Week 12	-2.57 (2.53)	-3.99 (2.94)	-3.84 (2.74)	-3.84 (2.84)	-3.64 (2.54)
Change at Week 16	-2.56 (2.53)	-3.99 (2.96)	-3.83 (2.72)	-3.85 (2.83)	-3.65 (2.54)

15. Secondary Outcome

Title	Change From Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 1, 2, 4, 8, 12, and 16
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.
Time Frame	Baseline, Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
Baseline	8.50 (1.39)	8.65 (1.34)	8.44 (1.17)	8.40 (1.33)	8.25 (1.26)
Change at Week 1	-2.21 (2.75)	-3.14 (2.56)	-2.71 (2.69)	-3.30 (2.59)	-3.45 (2.95)
Change at Week 2	-2.74 (2.72)	-3.93 (2.93)	-3.54 (2.82)	-3.50 (2.99)	-2.95 (2.83)
Change at Week 4	-2.92 (2.69)	-4.36 (3.00)	-3.76 (2.84)	-4.08 (3.02)	-3.89 (2.58)
Change at Week 8	-2.85 (2.57)	-4.03 (3.06)	-3.98 (2.76)	-3.98 (2.93)	-3.86 (2.60)
Change at Week 12	-2.93 (2.61)	-4.00 (3.04)	-3.98 (2.78)	-3.98 (2.94)	-3.89 (2.64)
Change at Week 16	-2.92 (2.60)	-3.96 (3.08)	-3.94 (2.73)	-3.99 (2.94)	-3.92 (2.62)

16. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16
Description	SF-36v2 is a standardized self-administered survey evaluating 8 aspects/domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The total score for each domain is scaled 0-100 (100 = highest level of functioning).
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	71	73	62	86	84
Baseline: General Health Score	66.01 (18.38)	66.81 (20.54)	68.73 (17.95)	65.72 (19.98)	65.02 (19.42)
Baseline: Physical Function Score	34.30 (23.80)	32.05 (20.80)	30.63 (18.07)	38.55 (23.58)	37.35 (21.80)
Baseline: Role Physical Score	40.85 (27.57)	42.64 (27.68)	39.42 (23.07)	47.31 (27.70)	49.03 (27.03)
Baseline: Bodily Pain Score	34.18 (19.25)	32.85 (16.97)	34.10 (17.02)	33.70 (19.80)	36.31 (18.06)
Baseline: Vitality Score	50.62 (20.97)	52.91 (21.98)	55.04 (18.35)	51.74 (20.49)	50.45 (19.97)
Baseline: Social Function Score	64.96 (30.95)	69.69 (26.59)	72.18 (24.94)	65.41 (28.42)	69.79 (25.61)
Baseline: Role Emotional Score	67.72 (31.81)	73.63 (32.36)	73.25 (29.99)	73.45 (30.85)	73.31 (28.22)
Baseline: Mental Health Score	72.89 (20.03)	73.90 (19.10)	77.82 (16.59)	75.41 (17.41)	75.77 (16.84)
Change at Week 16: General Health Score	0.07 (0.59)	-0.48 (2.91)	-0.08 (0.64)	0.00 (0.00)	0.44 (4.04)
Change at Week 16: Physical Function Score	0.35 (2.97)	-0.21 (4.75)	0.48 (3.81)	0.35 (3.23)	0.06 (0.55)
Change at Week 16: Role Physical Score	0.26 (2.23)	-0.77 (9.99)	0.20 (1.59)	0.00 (0.00)	0.22 (2.05)
Change at Week 16: Bodily Pain Score	0.30 (2.49)	-0.29 (2.34)	0.31 (2.41)	0.00 (0.00)	0.36 (3.27)
Change at Week 16: Vitality Score	0.18 (1.48)	-0.43 (3.66)	-0.40 (3.18)	0.07 (0.67)	0.22 (2.05)
Change at Week 16: Social Function Score	0.18 (1.48)	-0.34 (2.93)	0.60 (4.76)	0.29 (2.70)	0.30 (2.73)
Change at Week 16: Role Emotional Score	0.00 (0.00)	0.68 (5.85)	0.13 (1.06)	0.29 (2.70)	0.10 (0.91)
Change at Week 16: Mental Health Score	0.00 (0.00)	0.14 (1.17)	-0.56 (4.45)	0.23 (2.16)	-0.18 (1.64)

17. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16
Description	SF-36v2: standardized self-administered survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, 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.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	71	73	62	86	84
Baseline: Physical Component Score	-1.78 (0.81)	-1.86 (0.79)	-1.93 (0.70)	-1.71 (0.88)	-1.68 (0.82)
Baseline: Mental Component Score	0.03 (1.25)	0.27 (1.23)	0.44 (1.11)	0.16 (1.17)	0.19 (1.08)
Change at Week 16: Physical Component Score	0.01 (0.12)	-0.03 (0.26)	0.02 (0.15)	0.00 (0.01)	0.02 (0.14)
Change at Week 16: Mental Component Score	-0.00 (0.02)	0.02 (0.09)	-0.02 (0.13)	0.01 (0.12)	-0.00 (0.00)

18. Secondary Outcome

Title	Time to Discontinuation Due to Lack of Efficacy
Description	Median time to discontinuation due to lack of efficacy for participants who discontinued due to lack of efficacy was reported.
Time Frame	Baseline 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 or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	4	3	1	0	4
Median (Full Range) [days]	14.0	29.0	8.0	16.5

19. Secondary Outcome

Title	Percentage of Participants Who Used Rescue Medication
Description	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Incidence of rescue medication use is calculated as any use of rescue medication during the study week in question.
Time Frame	Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT population. LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	71	73	59	82	81
Week 1	70.0 97.2%	54.8 74.1%	57.9 91.9%	53.1 61.7%	50.0 59.5%
Week 2	56.3 78.2%	47.9 64.7%	52.5 83.3%	57.3 66.6%	55.0 65.5%
Week 4	43.7 60.7%	38.4 51.9%	39.0 61.9%	40.2 46.7%	37.0 44%
Week 8	45.1 62.6%	30.1 40.7%	40.7 64.6%	35.4 41.2%	42.0 50%
Week 12	43.7 60.7%	28.8 38.9%	39.0 61.9%	35.4 41.2%	39.5 47%
Week 16	43.7 60.7%	28.8 38.9%	39.0 61.9%	35.4 41.2%	39.5 47%

20. Secondary Outcome

Title	Duration of Rescue Medication Use
Description	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. Duration of rescue medication use is calculated as the number of study days per week when any rescue medication was taken.
Time Frame	Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT population. LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	71	73	59	82	81
Week 1	2.2 (2.25)	1.8 (2.14)	1.7 (2.01)	1.6 (2.07)	1.5 (2.13)
Week 2	2.0 (2.27)	1.3 (1.88)	1.7 (2.06)	1.5 (1.72)	1.7 (2.15)
Week 4	1.6 (2.41)	1.0 (1.63)	1.2 (2.01)	1.0 (1.82)	1.4 (2.33)
Week 8	1.6 (2.41)	0.8 (1.48)	1.5 (2.32)	0.8 (1.61)	1.5 (2.33)
Week 12	1.5 (2.32)	0.8 (1.53)	1.4 (2.29)	0.8 (1.69)	1.4 (2.33)
Week 16	1.5 (2.32)	0.8 (1.53)	1.4 (2.29)	0.8 (1.69)	1.4 (2.33)

21. Secondary Outcome

Title	Amount of Rescue Medication Taken
Description	In case of inadequate pain relief for osteoarthritis, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. The amount of rescue medication taken is the total dose (in mg) of acetaminophen rescue medication over the study week in question.
Time Frame	Weeks 1, 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

ITT population. LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	71	73	59	82	81
Week 1	3128.57 (3529.06)	2609.59 (3737.24)	2324.56 (3291.62)	2425.93 (3976.58)	1631.25 (2616.58)
Week 2	3077.46 (4623.42)	1753.42 (3210.36)	2440.68 (3312.83)	2189.02 (3864.72)	2425.00 (3693.22)
Week 4	2556.34 (4842.93)	1239.73 (2691.43)	1889.83 (4100.11)	1445.12 (2946.02)	1716.05 (3534.60)
Week 8	2464.79 (4729.33)	1047.95 (2636.77)	2042.37 (4175.35)	981.71 (2028.26)	1777.78 (3280.62)
Week 12	2140.85 (4297.16)	1061.64 (2658.77)	1940.68 (4132.59)	951.22 (1888.25)	1654.32 (3242.92)
Week 16	2140.85 (4297.16)	1061.64 (2658.77)	1940.68 (4132.59)	951.22 (1888.25)	1654.32 (3242.92)

22. Other Pre-specified Outcome

Title	Number of Participants With Treatment-Emergent 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. An 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. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame	Baseline up to 112 days after last dose of study treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
AEs	37 51.4%	35 47.3%	31 49.2%	36 41.9%	44 52.4%
SAEs	2 2.8%	2 2.7%	0 0%	0 0%	1 1.2%

23. Other Pre-specified Outcome

Title	Number of Participants With Abnormal Laboratory Findings
Description	Laboratory examination included blood chemistry, hematology and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.
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 or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	68	71	61	82	83
Count of Participants [Participants]	56 77.8%	48 64.9%	44 69.8%	61 70.9%	60 71.4%

24. Other Pre-specified Outcome

Title	Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Description	Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate (HR). Number of participants with clinically significant abnormal ECG findings reported as adverse events were presented.
Time Frame	Baseline 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 or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	70	73	62	84	84
Count of Participants [Participants]	0 0%	1 1.4%	1 1.6%	0 0%	1 1.2%

25. Other Pre-specified Outcome

Title	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24
Description	The NIS constitutes the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) are scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score range 0-244 with higher score = more impairment.
Time Frame	Baseline, Weeks 2, 4, 8, 12, 16, and 24

Outcome Measure Data

Analysis Population Description

ITT population. LOCF method was used to impute missing values. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	72	63	85	84
Baseline	1.06 (3.13)	1.53 (5.09)	0.86 (2.40)	0.75 (2.69)	1.71 (3.85)
Change at Week 2	-0.09 (2.20)	-0.26 (1.79)	-0.13 (0.72)	-0.08 (1.97)	-0.36 (2.17)
Change at Week 4	0.11 (1.31)	-0.14 (2.22)	-0.19 (0.87)	-0.22 (1.51)	0.14 (3.14)
Change at Week 8	-0.07 (1.60)	-0.14 (2.34)	-0.26 (0.99)	-0.20 (1.59)	-0.39 (2.45)
Change at Week 12	-0.10 (1.47)	-0.27 (2.07)	-0.32 (1.32)	-0.40 (2.34)	-0.81 (2.80)
Change at Week 16	-0.16 (1.15)	-0.63 (2.60)	-0.23 (1.26)	-0.33 (1.65)	-0.62 (2.18)
Change at Week 24	-0.19 (2.02)	-0.86 (3.05)	-0.55 (1.53)	-0.52 (2.01)	-0.90 (2.34)

26. Other Pre-specified Outcome

Title	Number of Participants With Anti-drug Antibodies (ADA)
Description	Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.
Time Frame	Baseline, Weeks 8, 16, 24 or Early Termination

Outcome Measure Data

Analysis Population Description

ITT population. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	75	66	87	85
Baseline	0 0%	0 0%	1 1.6%	0 0%
Week 8	1 1.4%	0 0%	1 1.6%	0 0%
Week 16	0 0%	0 0%	0 0%	0 0%
Week 24 (End of treatment)	1 1.4%	3 4.1%	1 1.6%	1 1.2%

27. Other Pre-specified Outcome

Title	Number of Participants With Abnormal Physical Examination Findings
Description	Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat, lungs and thyroid.
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description

Data was not summarized separately and any clinically significant abnormality in physical finding was reported as an adverse event in this study.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	0	0	0	0	0

28. Other Pre-specified Outcome

Title	Number of Participants With Clinically Significant Abnormality in Vital Signs
Description	Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, pulse rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs reported as adverse events were presented.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of intravenous or subcutaneous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	73	63	86	84
Count of Participants [Participants]	1 1.4%	0 0%	1 1.6%	1 1.2%	0 0%

29. Other Pre-specified Outcome

Title	Number of Participants With Injection and Infusion Site Reactions
Description	The injection and infusion site reactions were assessed based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after administration of subcutaneous injection or intravenous infusion.
Time Frame	Baseline, Weeks 1, 2, 4, 8, 12, 16, and 24

Outcome Measure Data

Analysis Population Description

ITT population. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	72	63	85	84
Baseline: Injection site	1 1.4%	2 2.7%	0 0%	1 1.2%	1 1.2%
Baseline: Infusion site	1 1.4%	2 2.7%	1 1.6%	1 1.2%	0 0%
Week 1: Injection site	1 1.4%	0 0%	0 0%	2 2.3%	1 1.2%
Week 1: Infusion site	1 1.4%	0 0%	0 0%	0 0%	2 2.4%
Week 2: Injection site	0 0%	0 0%	0 0%	0 0%	1 1.2%
Week 2: Infusion site	0 0%	0 0%	0 0%	0 0%	0 0%
Week 4: Injection site	0 0%	0 0%	0 0%	0 0%	0 0%
Week 4: Infusion site	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8: Injection site	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8: Infusion site	0 0%	0 0%	0 0%	0 0%	0 0%
Week 12: Injection site	0 0%	0 0%	0 0%	0 0%	0 0%
Week 12: Infusion site	0 0%	0 0%	0 0%	0 0%	0 0%
Week 16: Injection site	0 0%	0 0%	0 0%	0 0%	0 0%
Week 16: Infusion site	0 0%	0 0%	0 0%	0 0%	0 0%
Week 24: Injection site	0 0%	0 0%	0 0%	0 0%	0 0%
Week 24: Infusion site	0 0%	0 0%	0 0%	0 0%	0 0%

30. Other Pre-specified Outcome

Title	Plasma Tanezumab Concentration
Time Frame	Baseline (pre-dose), Weeks 1, 2, 4, 8 (pre-dose), 12, 16, 24 or End of treatment

Outcome Measure Data

Analysis Population Description

ITT population. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	69	60	82	80
Baseline: pre-dose	12.65 (36.610)	14.43 (45.560)	30.90 (81.647)	138.5 (820.35)
Week 1	265.7 (132.17)	480.7 (249.53)	1015 (429.96)	1700 (874.30)
Week 2	270.2 (110.93)	486.3 (160.85)	1012 (350.47)	1378 (772.25)
Week 4	207.4 (95.228)	371.8 (185.63)	791.1 (228.97)	887.5 (280.47)
Week 8: pre-dose	81.51 (59.632)	158.1 (89.087)	370.2 (176.99)	428.1 (213.49)
Week 12	52.55 (92.620)	88.13 (150.90)	323.8 (349.02)	304.8 (286.23)
Week 16	99.73 (70.613)	257.0 (298.20)	628.6 (244.38)	501.7 (218.74)
Week 24 (End of treatment)	17.58 (38.959)	58.57 (142.04)	113.2 (139.49)	264.2 (960.42)

31. Other Pre-specified Outcome

Title	Total and Free Nerve Growth Factor (NGF) Concentration
Description	Serum samples were analyzed for determining total and free (unbound) NGF concentration. Total NGF was analyzed using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method and free (unbound) NGF was analyzed using a validated, sensitive, and specific electrochemiluminescence (ECL) ligand binding assay.
Time Frame	Baseline (pre-dose), Weeks 1, 2, 4, 8 (pre-dose), 12, 16, and 24 or End of treatment

Outcome Measure Data

Analysis Population Description

ITT population. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	66	69	60	82	80
Baseline (pre-dose): Total NGF	34.9 (10.1)	44.6 (41.8)	79.2 (276)	35.1 (8.7)	32.7 (9.2)
Baseline (pre-dose): Free NGF	1.7 (0.9)	1.8 (1.0)	1.6 (0.8)	1.5 (0.7)	1.5 (0.8)
Week 1: Total NGF	71.3 (232)	742 (302)	941 (419)	1196 (452)	1432 (477)
Week 1: Free NGF	1.6 (1.2)	1.1 (1.1)	0.9 (2.1)	0.2 (0.6)	0.1 (0.4)
Week 2: Total NGF	35.0 (13.8)	1202 (400)	1497 (532)	1867 (588)	2149 (601)
Week 2: Free NGF	1.7 (0.7)	2.5 (1.4)	2.1 (1.4)	0.8 (1.0)	0.8 (1.2)
Week 4: Total NGF	35.5 (13.4)	1596 (542)	2108 (1129)	2554 (828)	2629 (750)
Week 4: Free NGF	1.7 (1.0)	3.3 (1.5)	3.4 (1.4)	2.5 (1.3)	2.7 (1.4)
Week 8 (pre-dose): Total NGF	35.7 (12.8)	1388 (606)	1867 (890)	2544 (869)	2724 (931)
Week 8 (pre-dose): Free NGF	1.6 (0.8)	2.3 (1.3)	3.1 (1.4)	4.5 (2.5)	4.7 (1.9)
Week 12: Total NGF	33.7 (13.1)	798 (768)	1216 (751)	2253 (1024)	2521 (1166)
Week 12: Free NGF	1.7 (0.9)	1.4 (1.3)	1.9 (1.6)	3.1 (1.8)	3.5 (1.8)
Week 16: Total NGF	35.2 (10.1)	1900 (1428)	1206 (830)	3320 (502)	4082 (1940)
Week 16: Free NGF	2.0 (0.7)	1.9 (1.2)	3.7 (4.1)	5.9 (4.3)	5.3 (1.5)
Week 24 (End of treatment): Total NGF	31.7 (10.9)	251 (323)	489 (634)	1114 (737)	1445 (997)
Week 24 (End of treatment): Free NGF	1.6 (1.0)	1.5 (0.9)	1.5 (1.0)	2.1 (2.0)	2.0 (1.5)

32. Other Pre-specified Outcome

Title	Number of Participants With Intravenous or Subcutaneous Doses of Study Medication
Description	Number of participants were reported based on the maximum number of intravenous or subcutaneous doses of either tanezumab or placebo received.
Time Frame	Baseline up to Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	Tanezumab 2.5 mg Subcutaneous Injection	Tanezumab 5 mg Subcutaneous Injection	Tanezumab 10 mg Subcutaneous Injection	Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.	Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
Measure Participants	72	74	63	86	84
1 dose	65 90.3%	67 90.5%	56 88.9%	78 90.7%	77 91.7%
2 doses	7 9.7%	7 9.5%	7 11.1%	8 9.3%	7 8.3%

Adverse Events

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	Placebo		Tanezumab 2.5 mg Subcutaneous Injection		Tanezumab 5 mg Subcutaneous Injection		Tanezumab 10 mg Subcutaneous Injection		Tanezumab 10 mg Intravenous Infusion
Arm/Group Description	Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.		Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.		Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.		Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8.		Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8.
All Cause Mortality
	Placebo		Tanezumab 2.5 mg Subcutaneous Injection		Tanezumab 5 mg Subcutaneous Injection		Tanezumab 10 mg Subcutaneous Injection		Tanezumab 10 mg Intravenous Infusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Tanezumab 2.5 mg Subcutaneous Injection		Tanezumab 5 mg Subcutaneous Injection		Tanezumab 10 mg Subcutaneous Injection		Tanezumab 10 mg Intravenous Infusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/72 (2.8%)		2/74 (2.7%)		0/63 (0%)		0/86 (0%)		1/84 (1.2%)
General disorders
Oedema peripheral	0/72 (0%)		0/74 (0%)		0/63 (0%)		0/86 (0%)		1/84 (1.2%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/72 (1.4%)		2/74 (2.7%)		0/63 (0%)		0/86 (0%)		0/84 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant	1/72 (1.4%)		0/74 (0%)		0/63 (0%)		0/86 (0%)		0/84 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Tanezumab 2.5 mg Subcutaneous Injection		Tanezumab 5 mg Subcutaneous Injection		Tanezumab 10 mg Subcutaneous Injection		Tanezumab 10 mg Intravenous Infusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/72 (36.1%)		24/74 (32.4%)		22/63 (34.9%)		29/86 (33.7%)		31/84 (36.9%)
Gastrointestinal disorders
Diarrhoea	0/72 (0%)		3/74 (4.1%)		0/63 (0%)		0/86 (0%)		1/84 (1.2%)
Nausea	2/72 (2.8%)		1/74 (1.4%)		0/63 (0%)		0/86 (0%)		0/84 (0%)
Vomiting	0/72 (0%)		2/74 (2.7%)		0/63 (0%)		0/86 (0%)		0/84 (0%)
General disorders
Chills	0/72 (0%)		0/74 (0%)		0/63 (0%)		0/86 (0%)		2/84 (2.4%)
Fatigue	0/72 (0%)		0/74 (0%)		0/63 (0%)		1/86 (1.2%)		3/84 (3.6%)
Influenza like illness	0/72 (0%)		0/74 (0%)		0/63 (0%)		0/86 (0%)		2/84 (2.4%)
Infusion site reaction	1/72 (1.4%)		2/74 (2.7%)		1/63 (1.6%)		1/86 (1.2%)		2/84 (2.4%)
Injection site reaction	2/72 (2.8%)		2/74 (2.7%)		0/63 (0%)		4/86 (4.7%)		3/84 (3.6%)
Oedema peripheral	0/72 (0%)		1/74 (1.4%)		3/63 (4.8%)		4/86 (4.7%)		2/84 (2.4%)
Infections and infestations
Bronchitis	0/72 (0%)		1/74 (1.4%)		0/63 (0%)		2/86 (2.3%)		1/84 (1.2%)
Upper respiratory tract infection	0/72 (0%)		2/74 (2.7%)		1/63 (1.6%)		0/86 (0%)		2/84 (2.4%)
Urinary tract infection	0/72 (0%)		2/74 (2.7%)		0/63 (0%)		2/86 (2.3%)		0/84 (0%)
Injury, poisoning and procedural complications
Contusion	0/72 (0%)		1/74 (1.4%)		2/63 (3.2%)		1/86 (1.2%)		0/84 (0%)
Fall	0/72 (0%)		2/74 (2.7%)		1/63 (1.6%)		1/86 (1.2%)		1/84 (1.2%)
Muscle strain	1/72 (1.4%)		1/74 (1.4%)		0/63 (0%)		2/86 (2.3%)		2/84 (2.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/72 (5.6%)		4/74 (5.4%)		7/63 (11.1%)		5/86 (5.8%)		5/84 (6%)
Back pain	0/72 (0%)		2/74 (2.7%)		1/63 (1.6%)		1/86 (1.2%)		0/84 (0%)
Joint effusion	0/72 (0%)		0/74 (0%)		2/63 (3.2%)		1/86 (1.2%)		0/84 (0%)
Joint swelling	4/72 (5.6%)		1/74 (1.4%)		2/63 (3.2%)		3/86 (3.5%)		1/84 (1.2%)
Muscle spasms	1/72 (1.4%)		1/74 (1.4%)		2/63 (3.2%)		1/86 (1.2%)		2/84 (2.4%)
Musculoskeletal pain	0/72 (0%)		2/74 (2.7%)		2/63 (3.2%)		2/86 (2.3%)		2/84 (2.4%)
Myalgia	1/72 (1.4%)		0/74 (0%)		0/63 (0%)		0/86 (0%)		2/84 (2.4%)
Osteoarthritis	4/72 (5.6%)		2/74 (2.7%)		0/63 (0%)		1/86 (1.2%)		0/84 (0%)
Pain in extremity	2/72 (2.8%)		1/74 (1.4%)		3/63 (4.8%)		4/86 (4.7%)		3/84 (3.6%)
Synovial cyst	0/72 (0%)		0/74 (0%)		0/63 (0%)		2/86 (2.3%)		0/84 (0%)
Tendonitis	0/72 (0%)		0/74 (0%)		2/63 (3.2%)		1/86 (1.2%)		0/84 (0%)
Nervous system disorders
Burning sensation	0/72 (0%)		1/74 (1.4%)		2/63 (3.2%)		0/86 (0%)		2/84 (2.4%)
Dizziness	3/72 (4.2%)		0/74 (0%)		0/63 (0%)		1/86 (1.2%)		2/84 (2.4%)
Headache	3/72 (4.2%)		5/74 (6.8%)		0/63 (0%)		5/86 (5.8%)		2/84 (2.4%)
Hypoaesthesia	0/72 (0%)		2/74 (2.7%)		1/63 (1.6%)		6/86 (7%)		2/84 (2.4%)
Paraesthesia	0/72 (0%)		1/74 (1.4%)		2/63 (3.2%)		6/86 (7%)		6/84 (7.1%)
Sensory disturbance	0/72 (0%)		0/74 (0%)		0/63 (0%)		2/86 (2.3%)		0/84 (0%)
Psychiatric disorders
Depression	0/72 (0%)		0/74 (0%)		0/63 (0%)		0/86 (0%)		2/84 (2.4%)
Respiratory, thoracic and mediastinal disorders
Cough	2/72 (2.8%)		1/74 (1.4%)		1/63 (1.6%)		0/86 (0%)		1/84 (1.2%)
Oropharyngeal pain	0/72 (0%)		2/74 (2.7%)		0/63 (0%)		1/86 (1.2%)		0/84 (0%)

Limitations/Caveats

Due to United States Food and Drug Administration (FDA) imposed clinical hold, enrollment was stopped prematurely and, therefore, was insufficient to yield adequate power to fulfill the primary objectives.

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Certain Agreements

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

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