Arthritis, Osteoarthritis, Pain
Conditions
Keywords
safety, efficacy, parallel group, double-blind, multicenter, injection, infusion, osteoarthritis, bridging, subcutaneous, intravenous, tanezumab
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.
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.
Interventions
BIOLOGICALPlacebo IV
1 ml of placebo administered SC and IV once every 8 weeks.
BIOLOGICALPlacebo SC
1 ml of placebo administered SC and IV once every 8 weeks.
BIOLOGICALTanezumab SC
1 ml tanezumab injection SC administered every 8 weeks
BIOLOGICALTanezumab IV
1 ml tanezumab injection IV administered every 8 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Plasma Tanezumab Concentration | Baseline (pre-dose), Weeks 1, 2, 4, 8 (pre-dose), 12, 16, 24 or End of treatment | — |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8. | 72 |
| Tanezumab 2.5 mg Subcutaneous Injection Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8. | 74 |
| Tanezumab 5 mg Subcutaneous Injection Tanezumab (RN624 or PF-04383119) 5 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8. | 63 |
| Tanezumab 10 mg Subcutaneous Injection Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection along with placebo matched to tanezumab intravenous infusion at Baseline and Week 8. | 86 |
| Tanezumab 10 mg Intravenous Infusion Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion along with placebo matched to tanezumab subcutaneous injection at Baseline and Week 8. | 84 |
| Total | 379 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 0 | 2 |
| Overall Study | Lack of Efficacy | 4 | 3 | 1 | 0 | 4 |
| Overall Study | Lost to Follow-up | 2 | 2 | 0 | 3 | 0 |
| Overall Study | Other | 3 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Randomized, but not treated | 0 | 1 | 2 | 1 | 2 |
| Overall Study | Study Terminated by Sponsor | 51 | 56 | 53 | 68 | 68 |
| Overall Study | Withdrawal by Subject | 5 | 5 | 4 | 5 | 4 |
Baseline characteristics
| Characteristic | Placebo | Tanezumab 2.5 mg Subcutaneous Injection | Tanezumab 5 mg Subcutaneous Injection | Tanezumab 10 mg Subcutaneous Injection | Tanezumab 10 mg Intravenous Infusion | Total |
|---|---|---|---|---|---|---|
| Age, Customized 18 to 44 years | 8 Participants | 3 Participants | 7 Participants | 4 Participants | 3 Participants | 25 Participants |
| Age, Customized 45 to 64 years | 38 Participants | 48 Participants | 32 Participants | 62 Participants | 56 Participants | 236 Participants |
| Age, Customized Greater than or equal to (>=) 65 years | 26 Participants | 23 Participants | 24 Participants | 20 Participants | 25 Participants | 118 Participants |
| Sex: Female, Male Female | 47 Participants | 48 Participants | 36 Participants | 54 Participants | 48 Participants | 233 Participants |
| Sex: Female, Male Male | 25 Participants | 26 Participants | 27 Participants | 32 Participants | 36 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 26 / 72 | 24 / 74 | 22 / 63 | 29 / 86 | 31 / 84 |
| serious Total, serious adverse events | 2 / 72 | 2 / 74 | 0 / 63 | 0 / 86 | 1 / 84 |
Outcome results
Primary
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at 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.
Time frame: Baseline, Week 16
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Baseline | 3.47 units on a scale | Standard Deviation 0.63 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Change at Week 16 | -0.81 units on a scale | Standard Deviation 0.87 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Baseline | 3.43 units on a scale | Standard Deviation 0.64 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Change at Week 16 | -1.03 units on a scale | Standard Deviation 1.02 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Baseline | 3.43 units on a scale | Standard Deviation 0.61 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Change at Week 16 | -0.92 units on a scale | Standard Deviation 0.92 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Change at Week 16 | -1.08 units on a scale | Standard Deviation 1.1 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Baseline | 3.49 units on a scale | Standard Deviation 0.65 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Baseline | 3.30 units on a scale | Standard Deviation 0.51 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Change at Week 16 | -0.92 units on a scale | Standard Deviation 0.97 |
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at 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.
Time frame: Baseline, Week 16
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 7.31 units on a scale | Standard Deviation 1.41 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -2.79 units on a scale | Standard Deviation 2.14 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 7.70 units on a scale | Standard Deviation 1.46 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -3.84 units on a scale | Standard Deviation 2.79 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 7.48 units on a scale | Standard Deviation 1.43 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -3.77 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -3.88 units on a scale | Standard Deviation 2.72 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 7.51 units on a scale | Standard Deviation 1.29 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 7.24 units on a scale | Standard Deviation 1.37 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -3.63 units on a scale | Standard Deviation 2.41 |
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at 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.
Time frame: Baseline, Week 16
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.99 units on a scale | Standard Deviation 1.67 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -2.29 units on a scale | Standard Deviation 2.02 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 7.25 units on a scale | Standard Deviation 1.6 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -3.28 units on a scale | Standard Deviation 2.89 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 7.03 units on a scale | Standard Deviation 1.64 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -3.22 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -3.51 units on a scale | Standard Deviation 2.57 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 7.12 units on a scale | Standard Deviation 1.42 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.75 units on a scale | Standard Deviation 1.42 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -3.18 units on a scale | Standard Deviation 2.28 |
Secondary
Amount of Rescue Medication Taken
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Amount of Rescue Medication Taken | Week 4 | 2556.34 mg/week | Standard Deviation 4842.93 |
| Placebo | Amount of Rescue Medication Taken | Week 1 | 3128.57 mg/week | Standard Deviation 3529.06 |
| Placebo | Amount of Rescue Medication Taken | Week 16 | 2140.85 mg/week | Standard Deviation 4297.16 |
| Placebo | Amount of Rescue Medication Taken | Week 8 | 2464.79 mg/week | Standard Deviation 4729.33 |
| Placebo | Amount of Rescue Medication Taken | Week 2 | 3077.46 mg/week | Standard Deviation 4623.42 |
| Placebo | Amount of Rescue Medication Taken | Week 12 | 2140.85 mg/week | Standard Deviation 4297.16 |
| Tanezumab 2.5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 2 | 1753.42 mg/week | Standard Deviation 3210.36 |
| Tanezumab 2.5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 4 | 1239.73 mg/week | Standard Deviation 2691.43 |
| Tanezumab 2.5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 16 | 1061.64 mg/week | Standard Deviation 2658.77 |
| Tanezumab 2.5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 12 | 1061.64 mg/week | Standard Deviation 2658.77 |
| Tanezumab 2.5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 8 | 1047.95 mg/week | Standard Deviation 2636.77 |
| Tanezumab 2.5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 1 | 2609.59 mg/week | Standard Deviation 3737.24 |
| Tanezumab 5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 1 | 2324.56 mg/week | Standard Deviation 3291.62 |
| Tanezumab 5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 16 | 1940.68 mg/week | Standard Deviation 4132.59 |
| Tanezumab 5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 2 | 2440.68 mg/week | Standard Deviation 3312.83 |
| Tanezumab 5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 4 | 1889.83 mg/week | Standard Deviation 4100.11 |
| Tanezumab 5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 8 | 2042.37 mg/week | Standard Deviation 4175.35 |
| Tanezumab 5 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 12 | 1940.68 mg/week | Standard Deviation 4132.59 |
| Tanezumab 10 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 16 | 951.22 mg/week | Standard Deviation 1888.25 |
| Tanezumab 10 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 12 | 951.22 mg/week | Standard Deviation 1888.25 |
| Tanezumab 10 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 1 | 2425.93 mg/week | Standard Deviation 3976.58 |
| Tanezumab 10 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 8 | 981.71 mg/week | Standard Deviation 2028.26 |
| Tanezumab 10 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 2 | 2189.02 mg/week | Standard Deviation 3864.72 |
| Tanezumab 10 mg Subcutaneous Injection | Amount of Rescue Medication Taken | Week 4 | 1445.12 mg/week | Standard Deviation 2946.02 |
| Tanezumab 10 mg Intravenous Infusion | Amount of Rescue Medication Taken | Week 16 | 1654.32 mg/week | Standard Deviation 3242.92 |
| Tanezumab 10 mg Intravenous Infusion | Amount of Rescue Medication Taken | Week 4 | 1716.05 mg/week | Standard Deviation 3534.6 |
| Tanezumab 10 mg Intravenous Infusion | Amount of Rescue Medication Taken | Week 1 | 1631.25 mg/week | Standard Deviation 2616.58 |
| Tanezumab 10 mg Intravenous Infusion | Amount of Rescue Medication Taken | Week 8 | 1777.78 mg/week | Standard Deviation 3280.62 |
| Tanezumab 10 mg Intravenous Infusion | Amount of Rescue Medication Taken | Week 12 | 1654.32 mg/week | Standard Deviation 3242.92 |
| Tanezumab 10 mg Intravenous Infusion | Amount of Rescue Medication Taken | Week 2 | 2425.00 mg/week | Standard Deviation 3693.22 |
Secondary
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
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Change at Week 2 | -2.74 units on a scale | Standard Deviation 2.72 |
| Placebo | 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 | Change at Week 1 | -2.21 units on a scale | Standard Deviation 2.75 |
| Placebo | 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 | Change at Week 8 | -2.85 units on a scale | Standard Deviation 2.57 |
| Placebo | 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 | Change at Week 12 | -2.93 units on a scale | Standard Deviation 2.61 |
| Placebo | 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 | Change at Week 16 | -2.92 units on a scale | Standard Deviation 2.6 |
| Placebo | 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 | Change at Week 4 | -2.92 units on a scale | Standard Deviation 2.69 |
| Placebo | 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 | 8.50 units on a scale | Standard Deviation 1.39 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | 8.65 units on a scale | Standard Deviation 1.34 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 4 | -4.36 units on a scale | Standard Deviation 3 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 1 | -3.14 units on a scale | Standard Deviation 2.56 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 8 | -4.03 units on a scale | Standard Deviation 3.06 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 16 | -3.96 units on a scale | Standard Deviation 3.08 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 12 | -4.00 units on a scale | Standard Deviation 3.04 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 2 | -3.93 units on a scale | Standard Deviation 2.93 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 16 | -3.94 units on a scale | Standard Deviation 2.73 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 8 | -3.98 units on a scale | Standard Deviation 2.76 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | 8.44 units on a scale | Standard Deviation 1.17 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 1 | -2.71 units on a scale | Standard Deviation 2.69 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 2 | -3.54 units on a scale | Standard Deviation 2.82 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 4 | -3.76 units on a scale | Standard Deviation 2.84 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 12 | -3.98 units on a scale | Standard Deviation 2.78 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | 8.40 units on a scale | Standard Deviation 1.33 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 12 | -3.98 units on a scale | Standard Deviation 2.94 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 2 | -3.50 units on a scale | Standard Deviation 2.99 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 16 | -3.99 units on a scale | Standard Deviation 2.94 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 8 | -3.98 units on a scale | Standard Deviation 2.93 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 4 | -4.08 units on a scale | Standard Deviation 3.02 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 1 | -3.30 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 1 | -3.45 units on a scale | Standard Deviation 2.95 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 12 | -3.89 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 8 | -3.86 units on a scale | Standard Deviation 2.6 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 2 | -2.95 units on a scale | Standard Deviation 2.83 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 16 | -3.92 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 4 | -3.89 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg Intravenous Infusion | 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 | 8.25 units on a scale | Standard Deviation 1.26 |
Secondary
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
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Change at Week 2 | -2.40 units on a scale | Standard Deviation 2.75 |
| Placebo | 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 | Change at Week 8 | -2.51 units on a scale | Standard Deviation 2.49 |
| Placebo | 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 | Change at Week 12 | -2.57 units on a scale | Standard Deviation 2.53 |
| Placebo | 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 | Change at Week 16 | -2.56 units on a scale | Standard Deviation 2.53 |
| Placebo | 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 | Change at Week 1 | -2.01 units on a scale | Standard Deviation 2.76 |
| Placebo | 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 | Change at Week 4 | -2.68 units on a scale | Standard Deviation 2.63 |
| Placebo | 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 | 7.28 units on a scale | Standard Deviation 1.69 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 2 | -3.82 units on a scale | Standard Deviation 2.82 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 16 | -3.99 units on a scale | Standard Deviation 2.96 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 4 | -4.20 units on a scale | Standard Deviation 2.94 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | 7.73 units on a scale | Standard Deviation 1.74 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 8 | -4.01 units on a scale | Standard Deviation 2.94 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 1 | -3.14 units on a scale | Standard Deviation 2.54 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Change at Week 12 | -3.99 units on a scale | Standard Deviation 2.94 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 16 | -3.83 units on a scale | Standard Deviation 2.72 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 12 | -3.84 units on a scale | Standard Deviation 2.74 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 8 | -3.84 units on a scale | Standard Deviation 2.71 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | 7.43 units on a scale | Standard Deviation 1.71 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 4 | -3.60 units on a scale | Standard Deviation 2.67 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 1 | -2.67 units on a scale | Standard Deviation 2.74 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Change at Week 2 | -3.29 units on a scale | Standard Deviation 2.77 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 2 | -3.26 units on a scale | Standard Deviation 2.81 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 12 | -3.84 units on a scale | Standard Deviation 2.84 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | 7.41 units on a scale | Standard Deviation 1.58 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 1 | -3.30 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 4 | -3.91 units on a scale | Standard Deviation 2.89 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 8 | -3.85 units on a scale | Standard Deviation 2.85 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Change at Week 16 | -3.85 units on a scale | Standard Deviation 2.83 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 8 | -3.62 units on a scale | Standard Deviation 2.5 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 12 | -3.64 units on a scale | Standard Deviation 2.54 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 2 | -2.75 units on a scale | Standard Deviation 2.82 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 1 | -3.40 units on a scale | Standard Deviation 2.83 |
| Tanezumab 10 mg Intravenous Infusion | 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 | 7.24 units on a scale | Standard Deviation 1.68 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 4 | -3.64 units on a scale | Standard Deviation 2.56 |
| Tanezumab 10 mg Intravenous Infusion | 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 | Change at Week 16 | -3.65 units on a scale | Standard Deviation 2.54 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at 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).
Time frame: Baseline, Week 16
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Bodily Pain Score | 34.18 units on a scale | Standard Deviation 19.25 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Physical Function Score | 0.35 units on a scale | Standard Deviation 2.97 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Mental Health Score | 0.00 units on a scale | Standard Deviation 0 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: General Health Score | 66.01 units on a scale | Standard Deviation 18.38 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Vitality Score | 0.18 units on a scale | Standard Deviation 1.48 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Vitality Score | 50.62 units on a scale | Standard Deviation 20.97 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Physical Function Score | 34.30 units on a scale | Standard Deviation 23.8 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Mental Health Score | 72.89 units on a scale | Standard Deviation 20.03 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: General Health Score | 0.07 units on a scale | Standard Deviation 0.59 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Bodily Pain Score | 0.30 units on a scale | Standard Deviation 2.49 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Social Function Score | 64.96 units on a scale | Standard Deviation 30.95 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Social Function Score | 0.18 units on a scale | Standard Deviation 1.48 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Role Emotional Score | 0.00 units on a scale | Standard Deviation 0 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Role Physical Score | 40.85 units on a scale | Standard Deviation 27.57 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Role Physical Score | 0.26 units on a scale | Standard Deviation 2.23 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Role Emotional Score | 67.72 units on a scale | Standard Deviation 31.81 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Role Physical Score | 42.64 units on a scale | Standard Deviation 27.68 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Social Function Score | -0.34 units on a scale | Standard Deviation 2.93 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Physical Function Score | -0.21 units on a scale | Standard Deviation 4.75 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Mental Health Score | 73.90 units on a scale | Standard Deviation 19.1 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: General Health Score | -0.48 units on a scale | Standard Deviation 2.91 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Bodily Pain Score | 32.85 units on a scale | Standard Deviation 16.97 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Physical Function Score | 32.05 units on a scale | Standard Deviation 20.8 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: General Health Score | 66.81 units on a scale | Standard Deviation 20.54 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Role Emotional Score | 73.63 units on a scale | Standard Deviation 32.36 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Mental Health Score | 0.14 units on a scale | Standard Deviation 1.17 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Vitality Score | -0.43 units on a scale | Standard Deviation 3.66 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Vitality Score | 52.91 units on a scale | Standard Deviation 21.98 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Role Emotional Score | 0.68 units on a scale | Standard Deviation 5.85 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Bodily Pain Score | -0.29 units on a scale | Standard Deviation 2.34 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Social Function Score | 69.69 units on a scale | Standard Deviation 26.59 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Role Physical Score | -0.77 units on a scale | Standard Deviation 9.99 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Mental Health Score | 77.82 units on a scale | Standard Deviation 16.59 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: General Health Score | 68.73 units on a scale | Standard Deviation 17.95 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Physical Function Score | 30.63 units on a scale | Standard Deviation 18.07 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Role Physical Score | 39.42 units on a scale | Standard Deviation 23.07 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Bodily Pain Score | 34.10 units on a scale | Standard Deviation 17.02 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Vitality Score | 55.04 units on a scale | Standard Deviation 18.35 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Social Function Score | 72.18 units on a scale | Standard Deviation 24.94 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Role Emotional Score | 73.25 units on a scale | Standard Deviation 29.99 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: General Health Score | -0.08 units on a scale | Standard Deviation 0.64 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Physical Function Score | 0.48 units on a scale | Standard Deviation 3.81 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Role Physical Score | 0.20 units on a scale | Standard Deviation 1.59 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Bodily Pain Score | 0.31 units on a scale | Standard Deviation 2.41 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Vitality Score | -0.40 units on a scale | Standard Deviation 3.18 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Social Function Score | 0.60 units on a scale | Standard Deviation 4.76 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Role Emotional Score | 0.13 units on a scale | Standard Deviation 1.06 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Mental Health Score | -0.56 units on a scale | Standard Deviation 4.45 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Physical Function Score | 0.35 units on a scale | Standard Deviation 3.23 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Social Function Score | 65.41 units on a scale | Standard Deviation 28.42 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Role Physical Score | 0.00 units on a scale | Standard Deviation 0 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Vitality Score | 51.74 units on a scale | Standard Deviation 20.49 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Bodily Pain Score | 0.00 units on a scale | Standard Deviation 0 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Bodily Pain Score | 33.70 units on a scale | Standard Deviation 19.8 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: General Health Score | 65.72 units on a scale | Standard Deviation 19.98 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Vitality Score | 0.07 units on a scale | Standard Deviation 0.67 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Social Function Score | 0.29 units on a scale | Standard Deviation 2.7 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Role Physical Score | 47.31 units on a scale | Standard Deviation 27.7 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Physical Function Score | 38.55 units on a scale | Standard Deviation 23.58 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Mental Health Score | 75.41 units on a scale | Standard Deviation 17.41 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Mental Health Score | 0.23 units on a scale | Standard Deviation 2.16 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: General Health Score | 0.00 units on a scale | Standard Deviation 0 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Role Emotional Score | 73.45 units on a scale | Standard Deviation 30.85 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Role Emotional Score | 0.29 units on a scale | Standard Deviation 2.7 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Vitality Score | 0.22 units on a scale | Standard Deviation 2.05 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Physical Function Score | 0.06 units on a scale | Standard Deviation 0.55 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Social Function Score | 69.79 units on a scale | Standard Deviation 25.61 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Physical Function Score | 37.35 units on a scale | Standard Deviation 21.8 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Role Emotional Score | 0.10 units on a scale | Standard Deviation 0.91 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Role Physical Score | 49.03 units on a scale | Standard Deviation 27.03 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Role Physical Score | 0.22 units on a scale | Standard Deviation 2.05 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Vitality Score | 50.45 units on a scale | Standard Deviation 19.97 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Mental Health Score | -0.18 units on a scale | Standard Deviation 1.64 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: General Health Score | 65.02 units on a scale | Standard Deviation 19.42 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Mental Health Score | 75.77 units on a scale | Standard Deviation 16.84 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Bodily Pain Score | 0.36 units on a scale | Standard Deviation 3.27 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Bodily Pain Score | 36.31 units on a scale | Standard Deviation 18.06 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: Social Function Score | 0.30 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Baseline: Role Emotional Score | 73.31 units on a scale | Standard Deviation 28.22 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 16 | Change at Week 16: General Health Score | 0.44 units on a scale | Standard Deviation 4.04 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at 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.
Time frame: Baseline, Week 16
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Baseline: Physical Component Score | -1.78 z-score | Standard Deviation 0.81 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Baseline: Mental Component Score | 0.03 z-score | Standard Deviation 1.25 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Change at Week 16: Physical Component Score | 0.01 z-score | Standard Deviation 0.12 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Change at Week 16: Mental Component Score | -0.00 z-score | Standard Deviation 0.02 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Baseline: Physical Component Score | -1.86 z-score | Standard Deviation 0.79 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Change at Week 16: Mental Component Score | 0.02 z-score | Standard Deviation 0.09 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Baseline: Mental Component Score | 0.27 z-score | Standard Deviation 1.23 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Change at Week 16: Physical Component Score | -0.03 z-score | Standard Deviation 0.26 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Change at Week 16: Mental Component Score | -0.02 z-score | Standard Deviation 0.13 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Baseline: Mental Component Score | 0.44 z-score | Standard Deviation 1.11 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Change at Week 16: Physical Component Score | 0.02 z-score | Standard Deviation 0.15 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Baseline: Physical Component Score | -1.93 z-score | Standard Deviation 0.7 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Baseline: Physical Component Score | -1.71 z-score | Standard Deviation 0.88 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Baseline: Mental Component Score | 0.16 z-score | Standard Deviation 1.17 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Change at Week 16: Mental Component Score | 0.01 z-score | Standard Deviation 0.12 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Change at Week 16: Physical Component Score | 0.00 z-score | Standard Deviation 0.01 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Change at Week 16: Mental Component Score | -0.00 z-score | Standard Deviation 0 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Change at Week 16: Physical Component Score | 0.02 z-score | Standard Deviation 0.14 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Baseline: Mental Component Score | 0.19 z-score | Standard Deviation 1.08 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 16 | Baseline: Physical Component Score | -1.68 z-score | Standard Deviation 0.82 |
Secondary
Change From Baseline in Average Pain Score in the Index Knee at 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.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, and 16
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 4 | -2.10 units on a scale | Standard Deviation 2.3 |
| Placebo | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 2 | -1.74 units on a scale | Standard Deviation 2.27 |
| Placebo | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 16 | -2.33 units on a scale | Standard Deviation 2.59 |
| Placebo | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 12 | -2.32 units on a scale | Standard Deviation 2.59 |
| Placebo | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 7.12 units on a scale | Standard Deviation 1.75 |
| Placebo | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 1 | -1.17 units on a scale | Standard Deviation 1.93 |
| Placebo | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 8 | -2.27 units on a scale | Standard Deviation 2.6 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 8 | -2.55 units on a scale | Standard Deviation 2.47 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 6.96 units on a scale | Standard Deviation 1.97 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 2 | -2.54 units on a scale | Standard Deviation 2.25 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 4 | -2.85 units on a scale | Standard Deviation 2.35 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 12 | -2.48 units on a scale | Standard Deviation 2.44 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 1 | -1.36 units on a scale | Standard Deviation 1.69 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 16 | -2.49 units on a scale | Standard Deviation 2.45 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 2 | -2.23 units on a scale | Standard Deviation 2.33 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 1 | -1.27 units on a scale | Standard Deviation 1.73 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 6.72 units on a scale | Standard Deviation 2.1 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 4 | -2.95 units on a scale | Standard Deviation 2.41 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 8 | -2.85 units on a scale | Standard Deviation 2.26 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 16 | -2.93 units on a scale | Standard Deviation 2.39 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 12 | -3.00 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 2 | -2.47 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 12 | -3.00 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 16 | -2.97 units on a scale | Standard Deviation 2.65 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 1 | -1.93 units on a scale | Standard Deviation 1.99 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 8 | -3.01 units on a scale | Standard Deviation 2.63 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 6.93 units on a scale | Standard Deviation 1.76 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 4 | -3.12 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 8 | -2.34 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 2 | -1.78 units on a scale | Standard Deviation 2.17 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 1 | -1.82 units on a scale | Standard Deviation 1.96 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 12 | -2.34 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 4 | -2.37 units on a scale | Standard Deviation 2.25 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 6.44 units on a scale | Standard Deviation 1.88 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Average Pain Score in the Index Knee at Weeks 1, 2, 4, 8, 12 and 16 | Change at Week 16 | -2.33 units on a scale | Standard Deviation 2.29 |
Secondary
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at 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.
Time frame: Baseline, Weeks 1, 2, 4, 8, and 12
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -0.76 units on a scale | Standard Deviation 0.76 |
| Placebo | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -0.67 units on a scale | Standard Deviation 0.86 |
| Placebo | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -0.57 units on a scale | Standard Deviation 0.82 |
| Placebo | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -0.81 units on a scale | Standard Deviation 0.87 |
| Placebo | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -0.78 units on a scale | Standard Deviation 0.83 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -0.93 units on a scale | Standard Deviation 1.05 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -1.12 units on a scale | Standard Deviation 1.03 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -1.05 units on a scale | Standard Deviation 0.99 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -1.07 units on a scale | Standard Deviation 1 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -0.82 units on a scale | Standard Deviation 0.94 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -1.02 units on a scale | Standard Deviation 0.92 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -0.83 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -0.75 units on a scale | Standard Deviation 0.86 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | 0.95 units on a scale | Standard Deviation 0.92 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -0.94 units on a scale | Standard Deviation 0.93 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -1.08 units on a scale | Standard Deviation 1.1 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -0.87 units on a scale | Standard Deviation 0.85 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -1.08 units on a scale | Standard Deviation 1.1 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -1.03 units on a scale | Standard Deviation 1.1 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -0.94 units on a scale | Standard Deviation 1.01 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -0.88 units on a scale | Standard Deviation 0.9 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -0.90 units on a scale | Standard Deviation 0.96 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -0.88 units on a scale | Standard Deviation 1.04 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -0.92 units on a scale | Standard Deviation 0.97 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -0.58 units on a scale | Standard Deviation 0.93 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at 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.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, and 16
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Baseline | 7.17 units on a scale | Standard Deviation 1.44 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 16 | -2.44 units on a scale | Standard Deviation 1.9 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 1 | -1.88 units on a scale | Standard Deviation 2.04 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 2 | -2.18 units on a scale | Standard Deviation 2.01 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 4 | -2.39 units on a scale | Standard Deviation 2 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 8 | -2.40 units on a scale | Standard Deviation 1.88 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 12 | -2.45 units on a scale | Standard Deviation 1.9 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 12 | -3.50 units on a scale | Standard Deviation 2.79 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 1 | -2.89 units on a scale | Standard Deviation 2.36 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 16 | -3.49 units on a scale | Standard Deviation 2.81 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Baseline | 7.43 units on a scale | Standard Deviation 1.58 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 2 | -3.48 units on a scale | Standard Deviation 2.59 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 8 | -3.52 units on a scale | Standard Deviation 2.79 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 4 | -3.78 units on a scale | Standard Deviation 2.72 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Baseline | 7.26 units on a scale | Standard Deviation 1.44 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 16 | -3.49 units on a scale | Standard Deviation 2.47 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 4 | -3.46 units on a scale | Standard Deviation 2.49 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 8 | -3.54 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 12 | -3.54 units on a scale | Standard Deviation 2.53 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 2 | -3.07 units on a scale | Standard Deviation 2.55 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 1 | -2.43 units on a scale | Standard Deviation 2.25 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 16 | -3.75 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 1 | -3.15 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 2 | -3.19 units on a scale | Standard Deviation 2.5 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Baseline | 7.35 units on a scale | Standard Deviation 1.27 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 4 | -3.77 units on a scale | Standard Deviation 2.6 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 12 | -3.75 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 8 | -3.76 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 2 | -2.56 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 12 | -3.38 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 16 | -3.39 units on a scale | Standard Deviation 2.3 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Baseline | 6.99 units on a scale | Standard Deviation 1.3 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 1 | -3.21 units on a scale | Standard Deviation 2.48 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 8 | -3.34 units on a scale | Standard Deviation 2.27 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 4 | -3.37 units on a scale | Standard Deviation 2.36 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at 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.
Time frame: Baseline, Weeks 1, 2, 4, 8, and 12
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -2.74 units on a scale | Standard Deviation 2.09 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -2.15 units on a scale | Standard Deviation 2.25 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -2.81 units on a scale | Standard Deviation 2.13 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -2.46 units on a scale | Standard Deviation 2.28 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -2.74 units on a scale | Standard Deviation 2.2 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -3.89 units on a scale | Standard Deviation 2.76 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -4.15 units on a scale | Standard Deviation 2.72 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -3.76 units on a scale | Standard Deviation 2.69 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -3.87 units on a scale | Standard Deviation 2.76 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -3.06 units on a scale | Standard Deviation 2.47 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -3.63 units on a scale | Standard Deviation 2.59 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -2.67 units on a scale | Standard Deviation 2.56 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -3.23 units on a scale | Standard Deviation 2.7 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -3.80 units on a scale | Standard Deviation 2.64 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -3.81 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -3.88 units on a scale | Standard Deviation 2.72 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -3.27 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -3.89 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -3.89 units on a scale | Standard Deviation 2.83 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -3.19 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -3.58 units on a scale | Standard Deviation 2.47 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -3.59 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -3.41 units on a scale | Standard Deviation 2.76 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -3.62 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -2.59 units on a scale | Standard Deviation 2.64 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at 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.
Time frame: Baseline, Weeks 1, 2, 4, 8, and 12
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -2.26 units on a scale | Standard Deviation 2.01 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -1.75 units on a scale | Standard Deviation 2.24 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -2.31 units on a scale | Standard Deviation 2.02 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -1.97 units on a scale | Standard Deviation 2.08 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -2.21 units on a scale | Standard Deviation 2.07 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -3.31 units on a scale | Standard Deviation 2.86 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -3.55 units on a scale | Standard Deviation 2.81 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -3.27 units on a scale | Standard Deviation 2.73 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -3.29 units on a scale | Standard Deviation 2.87 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -2.78 units on a scale | Standard Deviation 2.49 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -3.20 units on a scale | Standard Deviation 2.52 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -2.22 units on a scale | Standard Deviation 2.26 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -2.89 units on a scale | Standard Deviation 2.57 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -3.28 units on a scale | Standard Deviation 2.53 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -3.27 units on a scale | Standard Deviation 2.55 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -3.50 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -2.99 units on a scale | Standard Deviation 2.3 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -3.51 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -3.57 units on a scale | Standard Deviation 2.53 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -3.01 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 4 | -3.17 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 8 | -3.13 units on a scale | Standard Deviation 2.25 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 1 | -2.99 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 12 | -3.16 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12 | Change at Week 2 | -2.45 units on a scale | Standard Deviation 2.36 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at 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.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, and 16
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 16 | -2.17 units on a scale | Standard Deviation 2.03 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 12 | -2.19 units on a scale | Standard Deviation 2.03 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 2 | -2.05 units on a scale | Standard Deviation 2.11 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 8 | -2.15 units on a scale | Standard Deviation 2.04 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 4 | -2.17 units on a scale | Standard Deviation 2.19 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 1 | -1.75 units on a scale | Standard Deviation 1.92 |
| Placebo | 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 | 7.19 units on a scale | Standard Deviation 1.78 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 8 | -3.32 units on a scale | Standard Deviation 3.18 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 1 | -2.78 units on a scale | Standard Deviation 2.65 |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | 7.33 units on a scale | Standard Deviation 2.2 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 12 | -3.30 units on a scale | Standard Deviation 3.19 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 2 | -3.38 units on a scale | Standard Deviation 2.81 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 4 | -3.61 units on a scale | Standard Deviation 3.05 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 16 | -3.30 units on a scale | Standard Deviation 3.2 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 2 | -3.10 units on a scale | Standard Deviation 2.71 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 12 | -3.52 units on a scale | Standard Deviation 2.69 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 4 | -3.52 units on a scale | Standard Deviation 2.7 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 1 | -2.40 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 8 | -3.52 units on a scale | Standard Deviation 2.68 |
| Tanezumab 5 mg Subcutaneous Injection | 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 | 7.26 units on a scale | Standard Deviation 1.73 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 16 | -3.47 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 12 | -3.86 units on a scale | Standard Deviation 2.87 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 1 | -3.18 units on a scale | Standard Deviation 2.65 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 2 | -3.38 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 4 | -3.85 units on a scale | Standard Deviation 2.82 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 8 | -3.87 units on a scale | Standard Deviation 2.89 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 16 | -3.87 units on a scale | Standard Deviation 2.87 |
| Tanezumab 10 mg Subcutaneous Injection | 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 | 7.41 units on a scale | Standard Deviation 1.59 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 4 | -3.38 units on a scale | Standard Deviation 2.72 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 2 | -2.64 units on a scale | Standard Deviation 2.61 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 1 | -3.24 units on a scale | Standard Deviation 2.7 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 16 | -3.37 units on a scale | Standard Deviation 2.69 |
| Tanezumab 10 mg Intravenous Infusion | 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 | 6.99 units on a scale | Standard Deviation 1.85 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 12 | -3.36 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 1, 2, 4, 8, 12, and 16 | Change at Week 8 | -3.32 units on a scale | Standard Deviation 2.66 |
Secondary
Duration of Rescue Medication Use
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Duration of Rescue Medication Use | Week 4 | 1.6 days/week | Standard Deviation 2.41 |
| Placebo | Duration of Rescue Medication Use | Week 2 | 2.0 days/week | Standard Deviation 2.27 |
| Placebo | Duration of Rescue Medication Use | Week 8 | 1.6 days/week | Standard Deviation 2.41 |
| Placebo | Duration of Rescue Medication Use | Week 1 | 2.2 days/week | Standard Deviation 2.25 |
| Placebo | Duration of Rescue Medication Use | Week 12 | 1.5 days/week | Standard Deviation 2.32 |
| Placebo | Duration of Rescue Medication Use | Week 16 | 1.5 days/week | Standard Deviation 2.32 |
| Tanezumab 2.5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 8 | 0.8 days/week | Standard Deviation 1.48 |
| Tanezumab 2.5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 12 | 0.8 days/week | Standard Deviation 1.53 |
| Tanezumab 2.5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 16 | 0.8 days/week | Standard Deviation 1.53 |
| Tanezumab 2.5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 2 | 1.3 days/week | Standard Deviation 1.88 |
| Tanezumab 2.5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 4 | 1.0 days/week | Standard Deviation 1.63 |
| Tanezumab 2.5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 1 | 1.8 days/week | Standard Deviation 2.14 |
| Tanezumab 5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 1 | 1.7 days/week | Standard Deviation 2.01 |
| Tanezumab 5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 12 | 1.4 days/week | Standard Deviation 2.29 |
| Tanezumab 5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 4 | 1.2 days/week | Standard Deviation 2.01 |
| Tanezumab 5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 8 | 1.5 days/week | Standard Deviation 2.32 |
| Tanezumab 5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 2 | 1.7 days/week | Standard Deviation 2.06 |
| Tanezumab 5 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 16 | 1.4 days/week | Standard Deviation 2.29 |
| Tanezumab 10 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 12 | 0.8 days/week | Standard Deviation 1.69 |
| Tanezumab 10 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 1 | 1.6 days/week | Standard Deviation 2.07 |
| Tanezumab 10 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 2 | 1.5 days/week | Standard Deviation 1.72 |
| Tanezumab 10 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 4 | 1.0 days/week | Standard Deviation 1.82 |
| Tanezumab 10 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 8 | 0.8 days/week | Standard Deviation 1.61 |
| Tanezumab 10 mg Subcutaneous Injection | Duration of Rescue Medication Use | Week 16 | 0.8 days/week | Standard Deviation 1.69 |
| Tanezumab 10 mg Intravenous Infusion | Duration of Rescue Medication Use | Week 4 | 1.4 days/week | Standard Deviation 2.33 |
| Tanezumab 10 mg Intravenous Infusion | Duration of Rescue Medication Use | Week 2 | 1.7 days/week | Standard Deviation 2.15 |
| Tanezumab 10 mg Intravenous Infusion | Duration of Rescue Medication Use | Week 1 | 1.5 days/week | Standard Deviation 2.13 |
| Tanezumab 10 mg Intravenous Infusion | Duration of Rescue Medication Use | Week 12 | 1.4 days/week | Standard Deviation 2.33 |
| Tanezumab 10 mg Intravenous Infusion | Duration of Rescue Medication Use | Week 16 | 1.4 days/week | Standard Deviation 2.33 |
| Tanezumab 10 mg Intravenous Infusion | Duration of Rescue Medication Use | Week 8 | 1.5 days/week | Standard Deviation 2.33 |
Secondary
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
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 | Week 16: >=60% reduction | 21 Participants |
| Placebo | 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 | Week 16: >=70% reduction | 13 Participants |
| Placebo | 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 | Week 16: Greater than 0% reduction | 63 Participants |
| Placebo | 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 | Week 16: >=50% reduction | 24 Participants |
| Placebo | 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 | Week 16: >=40% reduction | 32 Participants |
| Placebo | 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 | Week 16: >=20% reduction | 50 Participants |
| Placebo | 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 | Week 16: >=10% reduction | 57 Participants |
| Placebo | 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 | Week 16: 100% reduction | 1 Participants |
| Placebo | 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 | Week 16: >=90% reduction | 3 Participants |
| Placebo | 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 | Week 16: >=80% reduction | 11 Participants |
| Placebo | 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 | Week 16: >=30% reduction | 44 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=20% reduction | 56 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=10% reduction | 64 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=30% reduction | 45 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=40% reduction | 40 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=50% reduction | 34 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=70% reduction | 30 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=80% reduction | 24 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=90% reduction | 18 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: 100% reduction | 8 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: Greater than 0% reduction | 69 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=60% reduction | 30 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=30% reduction | 43 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=70% reduction | 26 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: Greater than 0% reduction | 57 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=80% reduction | 17 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=90% reduction | 11 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=20% reduction | 47 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=10% reduction | 53 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: 100% reduction | 3 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=40% reduction | 39 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=50% reduction | 36 Participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=60% reduction | 29 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: Greater than 0% reduction | 77 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=90% reduction | 12 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=50% reduction | 46 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: 100% reduction | 5 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=30% reduction | 60 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=60% reduction | 42 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=40% reduction | 54 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=70% reduction | 33 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=80% reduction | 22 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=20% reduction | 65 Participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=10% reduction | 72 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=40% reduction | 52 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=50% reduction | 44 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=90% reduction | 15 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=60% reduction | 34 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=80% reduction | 21 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: Greater than 0% reduction | 78 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=70% reduction | 26 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: 100% reduction | 8 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=20% reduction | 65 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=30% reduction | 59 Participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=10% reduction | 73 Participants |
Secondary
Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 1 | 11 Participants |
| Placebo | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 2 | 10 Participants |
| Placebo | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 9 Participants |
| Placebo | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 8 | 13 Participants |
| Placebo | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 14 Participants |
| Placebo | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 14 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 21 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 21 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 1 | 17 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 24 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 8 | 22 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 2 | 23 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 8 | 16 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 16 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 1 | 12 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 20 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 2 | 15 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 15 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 8 | 27 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 2 | 23 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 25 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 27 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 27 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 1 | 21 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 24 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 18 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 2 | 10 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 24 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 8 | 23 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 1 | 24 Participants |
Secondary
Percentage of Participants Who Used Rescue Medication
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Used Rescue Medication | Week 8 | 45.1 percentage of participants |
| Placebo | Percentage of Participants Who Used Rescue Medication | Week 12 | 43.7 percentage of participants |
| Placebo | Percentage of Participants Who Used Rescue Medication | Week 1 | 70.0 percentage of participants |
| Placebo | Percentage of Participants Who Used Rescue Medication | Week 2 | 56.3 percentage of participants |
| Placebo | Percentage of Participants Who Used Rescue Medication | Week 4 | 43.7 percentage of participants |
| Placebo | Percentage of Participants Who Used Rescue Medication | Week 16 | 43.7 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 4 | 38.4 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 8 | 30.1 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 2 | 47.9 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 16 | 28.8 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 12 | 28.8 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 1 | 54.8 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 1 | 57.9 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 2 | 52.5 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 4 | 39.0 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 8 | 40.7 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 12 | 39.0 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 16 | 39.0 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 2 | 57.3 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 16 | 35.4 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 1 | 53.1 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 12 | 35.4 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 4 | 40.2 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants Who Used Rescue Medication | Week 8 | 35.4 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants Who Used Rescue Medication | Week 16 | 39.5 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants Who Used Rescue Medication | Week 8 | 42.0 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants Who Used Rescue Medication | Week 2 | 55.0 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants Who Used Rescue Medication | Week 12 | 39.5 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants Who Used Rescue Medication | Week 1 | 50.0 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants Who Used Rescue Medication | Week 4 | 37.0 percentage of participants |
Secondary
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
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | Week 2: >=70% reduction | 18.1 percentage of participants |
| Placebo | 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 | Week 16: >=90% reduction | 4.2 percentage of participants |
| Placebo | 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 | Week 16: >=30% reduction | 61.1 percentage of participants |
| Placebo | 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 | Week 2: >=90% reduction | 8.3 percentage of participants |
| Placebo | 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 | Week 4: >=50% reduction | 31.9 percentage of participants |
| Placebo | 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 | Week 4: >=30% reduction | 56.9 percentage of participants |
| Placebo | 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 | Week 16: >=50% reduction | 33.3 percentage of participants |
| Placebo | 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 | Week 12: >=70% reduction | 18.1 percentage of participants |
| Placebo | 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 | Week 12: >=50% reduction | 34.7 percentage of participants |
| Placebo | 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 | Week 1: >=30% reduction | 36.1 percentage of participants |
| Placebo | 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 | Week 16: >=70% reduction | 18.1 percentage of participants |
| Placebo | 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 | Week 12: >=30% reduction | 61.1 percentage of participants |
| Placebo | 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 | Week 1: >=50% reduction | 25.0 percentage of participants |
| Placebo | 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 | Week 8: >=90% reduction | 4.2 percentage of participants |
| Placebo | 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 | Week 1: >=70% reduction | 13.9 percentage of participants |
| Placebo | 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 | Week 8: >=70% reduction | 16.7 percentage of participants |
| Placebo | 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 | Week 8: >=50% reduction | 33.3 percentage of participants |
| Placebo | 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 | Week 1: >=90% reduction | 8.3 percentage of participants |
| Placebo | 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 | Week 8: >=30% reduction | 59.7 percentage of participants |
| Placebo | 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 | Week 2: >=30% reduction | 48.6 percentage of participants |
| Placebo | 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 | Week 12: >=90% reduction | 4.2 percentage of participants |
| Placebo | 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 | Week 4: >=90% reduction | 5.6 percentage of participants |
| Placebo | 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 | Week 2: >=50% reduction | 30.6 percentage of participants |
| Placebo | 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 | Week 4: >=70% reduction | 19.4 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 1: >=50% reduction | 40.5 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 2: >=70% reduction | 36.5 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=70% reduction | 40.5 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=30% reduction | 60.8 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 12: >=70% reduction | 40.5 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 8: >=70% reduction | 40.5 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 2: >=90% reduction | 17.6 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=90% reduction | 24.3 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 4: >=50% reduction | 55.4 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 4: >=70% reduction | 44.6 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 1: >=70% reduction | 23.0 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 4: >=30% reduction | 66.2 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 2: >=30% reduction | 63.5 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 8: >=50% reduction | 47.3 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 12: >=50% reduction | 45.9 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 12: >=90% reduction | 24.3 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 2: >=50% reduction | 52.7 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 12: >=30% reduction | 62.2 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 4: >=90% reduction | 27.0 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 1: >=30% reduction | 54.1 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 1: >=90% reduction | 9.5 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 16: >=50% reduction | 45.9 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 8: >=90% reduction | 24.3 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | 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 | Week 8: >=30% reduction | 62.2 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 1: >=70% reduction | 23.8 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=50% reduction | 57.1 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=70% reduction | 41.3 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=90% reduction | 17.5 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 12: >=90% reduction | 19.0 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 1: >=30% reduction | 49.2 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 1: >=50% reduction | 33.3 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 1: >=90% reduction | 11.1 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 2: >=30% reduction | 57.1 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 2: >=50% reduction | 44.4 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 2: >=70% reduction | 30.2 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 2: >=90% reduction | 15.9 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 4: >=30% reduction | 65.1 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 4: >=50% reduction | 54.0 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 16: >=30% reduction | 68.3 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 4: >=70% reduction | 34.9 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 4: >=90% reduction | 19.0 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 8: >=30% reduction | 68.3 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 8: >=50% reduction | 57.1 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 8: >=70% reduction | 42.9 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 8: >=90% reduction | 19.0 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 12: >=30% reduction | 68.3 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 12: >=50% reduction | 57.1 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | 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 | Week 12: >=70% reduction | 42.9 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 1: >=50% reduction | 45.3 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 4: >=90% reduction | 16.3 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=70% reduction | 38.4 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 8: >=90% reduction | 15.1 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 4: >=70% reduction | 43.0 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 1: >=30% reduction | 65.1 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 1: >=70% reduction | 27.9 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 12: >=70% reduction | 38.4 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 12: >=30% reduction | 69.8 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 8: >=50% reduction | 53.5 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 12: >=90% reduction | 14.0 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 2: >=30% reduction | 61.6 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=50% reduction | 53.5 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 4: >=30% reduction | 66.3 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=30% reduction | 69.8 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 1: >=90% reduction | 5.8 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 2: >=90% reduction | 14.0 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 12: >=50% reduction | 53.5 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 4: >=50% reduction | 53.5 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 16: >=90% reduction | 14.0 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 8: >=70% reduction | 38.4 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 2: >=70% reduction | 27.9 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 8: >=30% reduction | 69.8 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | 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 | Week 2: >=50% reduction | 38.4 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 2: >=50% reduction | 39.3 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 4: >=70% reduction | 32.1 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 2: >=30% reduction | 54.8 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=70% reduction | 31.0 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 4: >=90% reduction | 13.1 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 1: >=90% reduction | 14.3 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=30% reduction | 70.2 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 8: >=30% reduction | 71.4 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 1: >=70% reduction | 33.3 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 8: >=50% reduction | 51.2 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 1: >=50% reduction | 51.2 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 12: >=70% reduction | 31.0 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 8: >=70% reduction | 29.8 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 1: >=30% reduction | 64.3 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 8: >=90% reduction | 16.7 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 12: >=90% reduction | 17.9 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=50% reduction | 52.4 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 12: >=30% reduction | 70.2 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 16: >=90% reduction | 17.9 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 4: >=30% reduction | 66.7 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 2: >=90% reduction | 6.0 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 4: >=50% reduction | 53.6 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 2: >=70% reduction | 20.2 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | 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 | Week 12: >=50% reduction | 51.2 percentage of participants |
Secondary
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 1 | 41.7 percentage of participants |
| Placebo | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 2 | 54.2 percentage of participants |
| Placebo | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 4 | 63.9 percentage of participants |
| Placebo | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 8 | 59.7 percentage of participants |
| Placebo | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 12 | 61.1 percentage of participants |
| Placebo | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 16 | 61.1 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 12 | 74.3 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 16 | 74.3 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 1 | 68.9 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 4 | 78.4 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 8 | 74.3 percentage of participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 2 | 68.9 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 8 | 74.6 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 12 | 74.6 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 1 | 58.7 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 4 | 74.6 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 2 | 68.3 percentage of participants |
| Tanezumab 5 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 16 | 74.6 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 8 | 79.1 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 2 | 64.0 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 4 | 72.1 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 16 | 79.1 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 12 | 79.1 percentage of participants |
| Tanezumab 10 mg Subcutaneous Injection | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 1 | 68.6 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 12 | 76.2 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 4 | 73.8 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 2 | 59.5 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 16 | 76.2 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 8 | 76.2 percentage of participants |
| Tanezumab 10 mg Intravenous Infusion | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 1 | 64.3 percentage of participants |
Secondary
Time to Discontinuation Due to Lack of Efficacy
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
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Discontinuation Due to Lack of Efficacy | 14.0 days |
| Tanezumab 2.5 mg Subcutaneous Injection | Time to Discontinuation Due to Lack of Efficacy | 29.0 days |
| Tanezumab 5 mg Subcutaneous Injection | Time to Discontinuation Due to Lack of Efficacy | 8.0 days |
| Tanezumab 10 mg Intravenous Infusion | Time to Discontinuation Due to Lack of Efficacy | 16.5 days |
Other Pre-specified
Change From Baseline in Neuropathy Impairment Score (NIS) at 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.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | 0.11 units on a scale | Standard Deviation 1.31 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -0.07 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -0.10 units on a scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -0.09 units on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -0.16 units on a scale | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 1.06 units on a scale | Standard Deviation 3.13 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -0.19 units on a scale | Standard Deviation 2.02 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 1.53 units on a scale | Standard Deviation 5.09 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -0.14 units on a scale | Standard Deviation 2.22 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -0.26 units on a scale | Standard Deviation 1.79 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -0.27 units on a scale | Standard Deviation 2.07 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -0.86 units on a scale | Standard Deviation 3.05 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -0.14 units on a scale | Standard Deviation 2.34 |
| Tanezumab 2.5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -0.63 units on a scale | Standard Deviation 2.6 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -0.32 units on a scale | Standard Deviation 1.32 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -0.55 units on a scale | Standard Deviation 1.53 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -0.23 units on a scale | Standard Deviation 1.26 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 0.86 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -0.13 units on a scale | Standard Deviation 0.72 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -0.19 units on a scale | Standard Deviation 0.87 |
| Tanezumab 5 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -0.26 units on a scale | Standard Deviation 0.99 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -0.40 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -0.33 units on a scale | Standard Deviation 1.65 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -0.20 units on a scale | Standard Deviation 1.59 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -0.08 units on a scale | Standard Deviation 1.97 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -0.52 units on a scale | Standard Deviation 2.01 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 0.75 units on a scale | Standard Deviation 2.69 |
| Tanezumab 10 mg Subcutaneous Injection | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -0.22 units on a scale | Standard Deviation 1.51 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -0.90 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | 0.14 units on a scale | Standard Deviation 3.14 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -0.81 units on a scale | Standard Deviation 2.8 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 1.71 units on a scale | Standard Deviation 3.85 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -0.36 units on a scale | Standard Deviation 2.17 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -0.39 units on a scale | Standard Deviation 2.45 |
| Tanezumab 10 mg Intravenous Infusion | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -0.62 units on a scale | Standard Deviation 2.18 |
Other Pre-specified
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 1 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 1 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 1 Participants |
Other Pre-specified
Number of Participants With Abnormal Laboratory Findings
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Abnormal Laboratory Findings | 56 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Abnormal Laboratory Findings | 48 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Abnormal Laboratory Findings | 44 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Abnormal Laboratory Findings | 61 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Abnormal Laboratory Findings | 60 Participants |
Other Pre-specified
Number of Participants With Abnormal Physical Examination Findings
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
Population: Data was not summarized separately and any clinically significant abnormality in physical finding was reported as an adverse event in this study.
Other Pre-specified
Number of Participants With Anti-drug Antibodies (ADA)
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) | Week 8 | 1 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) | Baseline | 0 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) | Week 16 | 0 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) | Week 24 (End of treatment) | 1 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Baseline | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Week 16 | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Week 24 (End of treatment) | 3 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Week 8 | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Week 16 | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Week 8 | 1 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Week 24 (End of treatment) | 1 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Baseline | 1 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Week 24 (End of treatment) | 1 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Week 16 | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Week 8 | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Anti-drug Antibodies (ADA) | Baseline | 0 Participants |
Other Pre-specified
Number of Participants With Clinically Significant Abnormality in Vital Signs
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Abnormality in Vital Signs | 1 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Clinically Significant Abnormality in Vital Signs | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Clinically Significant Abnormality in Vital Signs | 1 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Clinically Significant Abnormality in Vital Signs | 1 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Clinically Significant Abnormality in Vital Signs | 0 Participants |
Other Pre-specified
Number of Participants With Injection and Infusion Site Reactions
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 8: Injection site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 1: Injection site | 1 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 24: Infusion site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 4: Injection site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 2: Infusion site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 4: Infusion site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 8: Infusion site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 1: Infusion site | 1 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 24: Injection site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 16: Infusion site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 12: Injection site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 16: Injection site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Baseline: Injection site | 1 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 2: Injection site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Week 12: Infusion site | 0 Participants |
| Placebo | Number of Participants With Injection and Infusion Site Reactions | Baseline: Infusion site | 1 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 12: Infusion site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 12: Injection site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 1: Injection site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 1: Infusion site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 4: Injection site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 16: Infusion site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 24: Injection site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 2: Infusion site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 16: Injection site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 2: Injection site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 4: Infusion site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 24: Infusion site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 8: Infusion site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 8: Injection site | 0 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Baseline: Injection site | 2 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Baseline: Infusion site | 2 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 16: Infusion site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 1: Infusion site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 8: Infusion site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 12: Injection site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 24: Injection site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Baseline: Injection site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Baseline: Infusion site | 1 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 1: Injection site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 2: Injection site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 2: Infusion site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 4: Injection site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 4: Infusion site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 8: Injection site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 12: Infusion site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 16: Injection site | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 24: Infusion site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 1: Infusion site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 4: Injection site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 4: Infusion site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Baseline: Infusion site | 1 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 8: Injection site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 12: Injection site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Baseline: Injection site | 1 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 12: Infusion site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 16: Infusion site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 1: Injection site | 2 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 24: Infusion site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 16: Injection site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 8: Infusion site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 2: Injection site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 24: Injection site | 0 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Injection and Infusion Site Reactions | Week 2: Infusion site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 4: Injection site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 2: Injection site | 1 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 2: Infusion site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 4: Infusion site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Baseline: Infusion site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 1: Infusion site | 2 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 1: Injection site | 1 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 16: Injection site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 8: Injection site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 8: Infusion site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 12: Injection site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Baseline: Injection site | 1 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 16: Infusion site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 24: Infusion site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 24: Injection site | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Injection and Infusion Site Reactions | Week 12: Infusion site | 0 Participants |
Other Pre-specified
Number of Participants With Intravenous or Subcutaneous Doses of Study Medication
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Intravenous or Subcutaneous Doses of Study Medication | 1 dose | 65 Participants |
| Placebo | Number of Participants With Intravenous or Subcutaneous Doses of Study Medication | 2 doses | 7 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Intravenous or Subcutaneous Doses of Study Medication | 1 dose | 67 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Intravenous or Subcutaneous Doses of Study Medication | 2 doses | 7 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Intravenous or Subcutaneous Doses of Study Medication | 1 dose | 56 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Intravenous or Subcutaneous Doses of Study Medication | 2 doses | 7 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Intravenous or Subcutaneous Doses of Study Medication | 2 doses | 8 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Intravenous or Subcutaneous Doses of Study Medication | 1 dose | 78 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Intravenous or Subcutaneous Doses of Study Medication | 1 dose | 77 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Intravenous or Subcutaneous Doses of Study Medication | 2 doses | 7 Participants |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 37 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 35 Participants |
| Tanezumab 2.5 mg Subcutaneous Injection | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Tanezumab 5 mg Subcutaneous Injection | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 31 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 36 Participants |
| Tanezumab 10 mg Subcutaneous Injection | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 44 Participants |
| Tanezumab 10 mg Intravenous Infusion | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
Other Pre-specified
Plasma Tanezumab Concentration
Time frame: Baseline (pre-dose), Weeks 1, 2, 4, 8 (pre-dose), 12, 16, 24 or End of treatment
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma Tanezumab Concentration | Week 12 | 52.55 nanogram per milliliter (ng/mL) | Standard Deviation 92.62 |
| Placebo | Plasma Tanezumab Concentration | Week 16 | 99.73 nanogram per milliliter (ng/mL) | Standard Deviation 70.613 |
| Placebo | Plasma Tanezumab Concentration | Week 24 (End of treatment) | 17.58 nanogram per milliliter (ng/mL) | Standard Deviation 38.959 |
| Placebo | Plasma Tanezumab Concentration | Baseline: pre-dose | 12.65 nanogram per milliliter (ng/mL) | Standard Deviation 36.61 |
| Placebo | Plasma Tanezumab Concentration | Week 1 | 265.7 nanogram per milliliter (ng/mL) | Standard Deviation 132.17 |
| Placebo | Plasma Tanezumab Concentration | Week 2 | 270.2 nanogram per milliliter (ng/mL) | Standard Deviation 110.93 |
| Placebo | Plasma Tanezumab Concentration | Week 4 | 207.4 nanogram per milliliter (ng/mL) | Standard Deviation 95.228 |
| Placebo | Plasma Tanezumab Concentration | Week 8: pre-dose | 81.51 nanogram per milliliter (ng/mL) | Standard Deviation 59.632 |
| Tanezumab 2.5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 8: pre-dose | 158.1 nanogram per milliliter (ng/mL) | Standard Deviation 89.087 |
| Tanezumab 2.5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 1 | 480.7 nanogram per milliliter (ng/mL) | Standard Deviation 249.53 |
| Tanezumab 2.5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 16 | 257.0 nanogram per milliliter (ng/mL) | Standard Deviation 298.2 |
| Tanezumab 2.5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 2 | 486.3 nanogram per milliliter (ng/mL) | Standard Deviation 160.85 |
| Tanezumab 2.5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 12 | 88.13 nanogram per milliliter (ng/mL) | Standard Deviation 150.9 |
| Tanezumab 2.5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Baseline: pre-dose | 14.43 nanogram per milliliter (ng/mL) | Standard Deviation 45.56 |
| Tanezumab 2.5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 24 (End of treatment) | 58.57 nanogram per milliliter (ng/mL) | Standard Deviation 142.04 |
| Tanezumab 2.5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 4 | 371.8 nanogram per milliliter (ng/mL) | Standard Deviation 185.63 |
| Tanezumab 5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 4 | 791.1 nanogram per milliliter (ng/mL) | Standard Deviation 228.97 |
| Tanezumab 5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 24 (End of treatment) | 113.2 nanogram per milliliter (ng/mL) | Standard Deviation 139.49 |
| Tanezumab 5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Baseline: pre-dose | 30.90 nanogram per milliliter (ng/mL) | Standard Deviation 81.647 |
| Tanezumab 5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 1 | 1015 nanogram per milliliter (ng/mL) | Standard Deviation 429.96 |
| Tanezumab 5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 8: pre-dose | 370.2 nanogram per milliliter (ng/mL) | Standard Deviation 176.99 |
| Tanezumab 5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 2 | 1012 nanogram per milliliter (ng/mL) | Standard Deviation 350.47 |
| Tanezumab 5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 12 | 323.8 nanogram per milliliter (ng/mL) | Standard Deviation 349.02 |
| Tanezumab 5 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 16 | 628.6 nanogram per milliliter (ng/mL) | Standard Deviation 244.38 |
| Tanezumab 10 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 8: pre-dose | 428.1 nanogram per milliliter (ng/mL) | Standard Deviation 213.49 |
| Tanezumab 10 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 16 | 501.7 nanogram per milliliter (ng/mL) | Standard Deviation 218.74 |
| Tanezumab 10 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 12 | 304.8 nanogram per milliliter (ng/mL) | Standard Deviation 286.23 |
| Tanezumab 10 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Baseline: pre-dose | 138.5 nanogram per milliliter (ng/mL) | Standard Deviation 820.35 |
| Tanezumab 10 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 4 | 887.5 nanogram per milliliter (ng/mL) | Standard Deviation 280.47 |
| Tanezumab 10 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 1 | 1700 nanogram per milliliter (ng/mL) | Standard Deviation 874.3 |
| Tanezumab 10 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 24 (End of treatment) | 264.2 nanogram per milliliter (ng/mL) | Standard Deviation 960.42 |
| Tanezumab 10 mg Subcutaneous Injection | Plasma Tanezumab Concentration | Week 2 | 1378 nanogram per milliliter (ng/mL) | Standard Deviation 772.25 |
Other Pre-specified
Total and Free Nerve Growth Factor (NGF) Concentration
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 1: Total NGF | 71.3 picogram per milliliter (pg/mL) | Standard Deviation 232 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 16: Total NGF | 35.2 picogram per milliliter (pg/mL) | Standard Deviation 10.1 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 4: Total NGF | 35.5 picogram per milliliter (pg/mL) | Standard Deviation 13.4 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 4: Free NGF | 1.7 picogram per milliliter (pg/mL) | Standard Deviation 1 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose): Total NGF | 34.9 picogram per milliliter (pg/mL) | Standard Deviation 10.1 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 2: Total NGF | 35.0 picogram per milliliter (pg/mL) | Standard Deviation 13.8 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 2: Free NGF | 1.7 picogram per milliliter (pg/mL) | Standard Deviation 0.7 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 24 (End of treatment): Free NGF | 1.6 picogram per milliliter (pg/mL) | Standard Deviation 1 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 8 (pre-dose): Total NGF | 35.7 picogram per milliliter (pg/mL) | Standard Deviation 12.8 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose): Free NGF | 1.7 picogram per milliliter (pg/mL) | Standard Deviation 0.9 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 24 (End of treatment): Total NGF | 31.7 picogram per milliliter (pg/mL) | Standard Deviation 10.9 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 8 (pre-dose): Free NGF | 1.6 picogram per milliliter (pg/mL) | Standard Deviation 0.8 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 16: Free NGF | 2.0 picogram per milliliter (pg/mL) | Standard Deviation 0.7 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 12: Total NGF | 33.7 picogram per milliliter (pg/mL) | Standard Deviation 13.1 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 12: Free NGF | 1.7 picogram per milliliter (pg/mL) | Standard Deviation 0.9 |
| Placebo | Total and Free Nerve Growth Factor (NGF) Concentration | Week 1: Free NGF | 1.6 picogram per milliliter (pg/mL) | Standard Deviation 1.2 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 24 (End of treatment): Free NGF | 1.5 picogram per milliliter (pg/mL) | Standard Deviation 0.9 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 16: Total NGF | 1900 picogram per milliliter (pg/mL) | Standard Deviation 1428 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 12: Free NGF | 1.4 picogram per milliliter (pg/mL) | Standard Deviation 1.3 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 24 (End of treatment): Total NGF | 251 picogram per milliliter (pg/mL) | Standard Deviation 323 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 4: Total NGF | 1596 picogram per milliliter (pg/mL) | Standard Deviation 542 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose): Total NGF | 44.6 picogram per milliliter (pg/mL) | Standard Deviation 41.8 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 12: Total NGF | 798 picogram per milliliter (pg/mL) | Standard Deviation 768 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 4: Free NGF | 3.3 picogram per milliliter (pg/mL) | Standard Deviation 1.5 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 8 (pre-dose): Free NGF | 2.3 picogram per milliliter (pg/mL) | Standard Deviation 1.3 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 8 (pre-dose): Total NGF | 1388 picogram per milliliter (pg/mL) | Standard Deviation 606 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 1: Free NGF | 1.1 picogram per milliliter (pg/mL) | Standard Deviation 1.1 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 2: Total NGF | 1202 picogram per milliliter (pg/mL) | Standard Deviation 400 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 16: Free NGF | 1.9 picogram per milliliter (pg/mL) | Standard Deviation 1.2 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 2: Free NGF | 2.5 picogram per milliliter (pg/mL) | Standard Deviation 1.4 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 1: Total NGF | 742 picogram per milliliter (pg/mL) | Standard Deviation 302 |
| Tanezumab 2.5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose): Free NGF | 1.8 picogram per milliliter (pg/mL) | Standard Deviation 1 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 24 (End of treatment): Free NGF | 1.5 picogram per milliliter (pg/mL) | Standard Deviation 1 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose): Free NGF | 1.6 picogram per milliliter (pg/mL) | Standard Deviation 0.8 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 1: Total NGF | 941 picogram per milliliter (pg/mL) | Standard Deviation 419 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 1: Free NGF | 0.9 picogram per milliliter (pg/mL) | Standard Deviation 2.1 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 2: Free NGF | 2.1 picogram per milliliter (pg/mL) | Standard Deviation 1.4 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 8 (pre-dose): Total NGF | 1867 picogram per milliliter (pg/mL) | Standard Deviation 890 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 8 (pre-dose): Free NGF | 3.1 picogram per milliliter (pg/mL) | Standard Deviation 1.4 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 2: Total NGF | 1497 picogram per milliliter (pg/mL) | Standard Deviation 532 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 4: Total NGF | 2108 picogram per milliliter (pg/mL) | Standard Deviation 1129 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 4: Free NGF | 3.4 picogram per milliliter (pg/mL) | Standard Deviation 1.4 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 12: Total NGF | 1216 picogram per milliliter (pg/mL) | Standard Deviation 751 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 12: Free NGF | 1.9 picogram per milliliter (pg/mL) | Standard Deviation 1.6 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 16: Total NGF | 1206 picogram per milliliter (pg/mL) | Standard Deviation 830 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 16: Free NGF | 3.7 picogram per milliliter (pg/mL) | Standard Deviation 4.1 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 24 (End of treatment): Total NGF | 489 picogram per milliliter (pg/mL) | Standard Deviation 634 |
| Tanezumab 5 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose): Total NGF | 79.2 picogram per milliliter (pg/mL) | Standard Deviation 276 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 12: Free NGF | 3.1 picogram per milliliter (pg/mL) | Standard Deviation 1.8 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 24 (End of treatment): Total NGF | 1114 picogram per milliliter (pg/mL) | Standard Deviation 737 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 8 (pre-dose): Free NGF | 4.5 picogram per milliliter (pg/mL) | Standard Deviation 2.5 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 4: Free NGF | 2.5 picogram per milliliter (pg/mL) | Standard Deviation 1.3 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 1: Total NGF | 1196 picogram per milliliter (pg/mL) | Standard Deviation 452 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 2: Free NGF | 0.8 picogram per milliliter (pg/mL) | Standard Deviation 1 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 24 (End of treatment): Free NGF | 2.1 picogram per milliliter (pg/mL) | Standard Deviation 2 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 16: Free NGF | 5.9 picogram per milliliter (pg/mL) | Standard Deviation 4.3 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose): Total NGF | 35.1 picogram per milliliter (pg/mL) | Standard Deviation 8.7 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 16: Total NGF | 3320 picogram per milliliter (pg/mL) | Standard Deviation 502 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 1: Free NGF | 0.2 picogram per milliliter (pg/mL) | Standard Deviation 0.6 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 8 (pre-dose): Total NGF | 2544 picogram per milliliter (pg/mL) | Standard Deviation 869 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 4: Total NGF | 2554 picogram per milliliter (pg/mL) | Standard Deviation 828 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose): Free NGF | 1.5 picogram per milliliter (pg/mL) | Standard Deviation 0.7 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 12: Total NGF | 2253 picogram per milliliter (pg/mL) | Standard Deviation 1024 |
| Tanezumab 10 mg Subcutaneous Injection | Total and Free Nerve Growth Factor (NGF) Concentration | Week 2: Total NGF | 1867 picogram per milliliter (pg/mL) | Standard Deviation 588 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 12: Total NGF | 2521 picogram per milliliter (pg/mL) | Standard Deviation 1166 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 12: Free NGF | 3.5 picogram per milliliter (pg/mL) | Standard Deviation 1.8 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 1: Total NGF | 1432 picogram per milliliter (pg/mL) | Standard Deviation 477 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose): Total NGF | 32.7 picogram per milliliter (pg/mL) | Standard Deviation 9.2 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 16: Total NGF | 4082 picogram per milliliter (pg/mL) | Standard Deviation 1940 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 8 (pre-dose): Free NGF | 4.7 picogram per milliliter (pg/mL) | Standard Deviation 1.9 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 16: Free NGF | 5.3 picogram per milliliter (pg/mL) | Standard Deviation 1.5 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 8 (pre-dose): Total NGF | 2724 picogram per milliliter (pg/mL) | Standard Deviation 931 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 4: Free NGF | 2.7 picogram per milliliter (pg/mL) | Standard Deviation 1.4 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose): Free NGF | 1.5 picogram per milliliter (pg/mL) | Standard Deviation 0.8 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 24 (End of treatment): Total NGF | 1445 picogram per milliliter (pg/mL) | Standard Deviation 997 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 2: Free NGF | 0.8 picogram per milliliter (pg/mL) | Standard Deviation 1.2 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 24 (End of treatment): Free NGF | 2.0 picogram per milliliter (pg/mL) | Standard Deviation 1.5 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 1: Free NGF | 0.1 picogram per milliliter (pg/mL) | Standard Deviation 0.4 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 4: Total NGF | 2629 picogram per milliliter (pg/mL) | Standard Deviation 750 |
| Tanezumab 10 mg Intravenous Infusion | Total and Free Nerve Growth Factor (NGF) Concentration | Week 2: Total NGF | 2149 picogram per milliliter (pg/mL) | Standard Deviation 601 |