Osteoarthritis
Conditions
Keywords
Arthritis monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN-624 OA
Brief summary
The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.
Detailed description
This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Interventions
BIOLOGICALtanezumab
IV tanezumab 10 mg every 8 weeks (through Week 16)
DRUGdiclofenac
Oral diclofenac SR 75 mg BID for 32 weeks
OTHERIV placebo
IV placebo to match tanezumab every 8 weeks (through Week 16)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence X-ray grade equal to, or greater than, 2. * Patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen. * Pain and function levels as required by the protocol at Screening and Baseline. * Willing to discontinue all non-study pain medications throughout the study except as permitted per protocol. * Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion criteria
* Pregnant women. * BMI greater than 39. * History of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (RA), joint infections, neuropathic disorders, avascular necrosis, Paget's disease or tumors. * Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA. * Signs and symptoms of clinically significant cardiac disease within 6 months prior to screening. * Diagnosis or TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities. * History, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder. * At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 150 micro-mol/L in men or 133 micro-mol/L in women. * Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to Screening. * Known hypersensitivity to NSAIDs (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).
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 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline, Week 16 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Baseline, Week 16 | Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert 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 worst condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Weeks 2, 4, 8, 12, 16, and 24 | OMERACT-OARSI responder: participant has \>=50 percent (%) change and \>=2 absolute change from Baseline in either WOMAC pain or physical function subscale scores or at least 2 of the following being true: \>=20% change and \>=1 absolute change from Baseline in WOMAC pain subscale; \>=20% change and \>=1 absolute change from Baseline in the WOMAC physical function subscale; \>=20% change and \>=1 absolute change from Baseline in PGA of osteoarthritis. WOMAC pain and physical function score: 0 to 10 with higher score = worse response. PGA score: 1 = very good and 5 = very poor. |
| Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Baseline, Week 16 and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. Percentage of participants with cumulative reduction (as percent) (greater than 0%; \>= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16 and 24 were reported. |
| 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; LOCF | Baseline, Weeks 2, 4, 8, 12, 16, and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. Percentage of participants with reduction in WOMAC pain intensity of at least (\>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16, 24 and 32 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. |
| Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Weeks 2, 4, 8, 12, 16, and 24 | Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert 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 worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicated improvement. |
| Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Weeks 2, 4, 8, 12, 16, and 24 | Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert 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 worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicates improvement. |
| Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Participants were asked to assess index joint (knee/hip) pain during the past 24 hours on an 0-10 point integer scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline score was calculated as the mean of the scores in the index joint over the 3 days days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores in the index joint within each study week. The change from Baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score, where negative change indicated an improvement. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Baseline, Weeks 2, 4, 8, 12, 16, and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee/hip. Negative change indicated an improvement. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Baseline, Weeks 2, 4, 8, 12, 16, and 24 | WOMAC Index: 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 the hip and/or knee. WOMAC average score is the mean of the WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, with higher score indicating worse response. Greater reduction in WOMAC average score indicated greater improvement. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Baseline, Week 2, 4, 8, 12, 16, 24 | Participants answered the question: How much pain have you had when walking on a flat surface? Participants responded by using an 11-point scale where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Baseline, Weeks 2, 4, 8, 12, 16, and 24 | Participants answered the question: How much pain have you had when going up or down the stairs? Participants responded by using an 11-point scale, where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement. |
| Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline, Week 12, and 24 | SF-36v2 was a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and role limitations due to emotional problems, bodily pain, general health, vitality, and mental health. The total score and the score for a section was an average of the individual question scores, which were scaled 0-100. Higher scores reflected better participant status and positive change indicated an improvement. |
| Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Baseline, Week 12 and 24 | SF-36v2: standardized survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, role limitations due to physical and emotional problems, bodily pain, general health, vitality, mental health). Total score for each aspect were scaled 0-100. Higher scores reflect better participant status and positive change indicated an improvement. For obtaining physical and mental component scores, z-score for each scale=(observed score - mean score for general 1990 United States \[US\] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score \[better functioning\])/lower (in case of negative z-score \[worse functioning\]) participant's value was relative to the mean of the reference population. |
| Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | Baseline, Week 24 | EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). EQ-5D summary index was obtained with a formula that weights each level of the dimensions. The index-based score was interpreted along a continuum of 0 (death) to 1 (perfect health). Negative change from baseline represented worsening. |
| Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline, Week 24 | EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). Baseline EQ-5D individual health state profile was determined as number of participants no dysfunction, moderate or some dysfunction and extreme dysfunction and change from baseline in EQ-5D individual health state profile was determined as number of participants improved, no change or worsened. |
| Number of Participants Who Discontinued Due to Lack of Efficacy | Baseline up to end of study (Week 32) | Number of participants who discontinued due to lack of efficacy were reported. |
| Time to Discontinuation (TTD) Due to Lack of Efficacy | Baseline up to Week 16 and 24 | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 112 days after last intravenous dose (up to Week 32) | 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. AEs included SAEs as well as non-serious AEs which occurred during the trial. |
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Baseline, Weeks 2, 4, 8, 12, and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. |
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Baseline, Weeks 2, 4, 8, 12, and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Baseline, Weeks 2, 4, 8, 12, and 24 | Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert 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 worst condition. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Intravenous Doses of Study Medication | Day 1 up to Week 16 | Number of participants were reported based on the maximum number of intravenous (IV) doses of either tanezumab or placebo received. |
Countries
Austria, France, Germany, Poland, Romania, Russia, Spain, Sweden, Ukraine, United Kingdom
Participant flow
Recruitment details
Participants with osteoarthritis of knee or hip who were receiving and tolerating stable dose of diclofenac 150 milligram (mg) per day but required additional pain relief were recruited in this study.
Pre-assignment details
After screening, participants received study supplied diclofenac slow release (SR) 75 mg tablet twice daily for a minimum of 14 days prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Placebo + Diclofenac Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 milligram (mg) slow release tablet orally twice daily up to Week 32. | 152 |
| Tanezumab 2.5 mg + Diclofenac Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. | 157 |
| Tanezumab 5 mg + Diclofenac Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. | 150 |
| Tanezumab 10 mg + Diclofenac Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. | 145 |
| Total | 604 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 8 | 11 | 9 |
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 9 | 3 | 7 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 |
| Overall Study | Other | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 | 0 | 1 |
| Overall Study | Randomized but not treated | 2 | 0 | 1 | 0 |
| Overall Study | Terminated by sponsor | 105 | 112 | 102 | 99 |
| Overall Study | Withdrawal by Subject | 15 | 11 | 11 | 12 |
Baseline characteristics
| Characteristic | Placebo + Diclofenac | Tanezumab 2.5 mg + Diclofenac | Tanezumab 5 mg + Diclofenac | Tanezumab 10 mg + Diclofenac | Total |
|---|---|---|---|---|---|
| Age, Customized 18 to 44 years | 4 Participants | 6 Participants | 4 Participants | 1 Participants | 15 Participants |
| Age, Customized 45 to 64 years | 84 Participants | 86 Participants | 88 Participants | 78 Participants | 336 Participants |
| Age, Customized Greater than or equal to (>=) 65 years | 64 Participants | 65 Participants | 58 Participants | 66 Participants | 253 Participants |
| Sex: Female, Male Female | 118 Participants | 121 Participants | 110 Participants | 120 Participants | 469 Participants |
| Sex: Female, Male Male | 34 Participants | 36 Participants | 40 Participants | 25 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 38 / 152 | 36 / 157 | 48 / 150 | 46 / 145 |
| serious Total, serious adverse events | 8 / 152 | 12 / 157 | 8 / 150 | 10 / 145 |
Outcome results
Primary
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16
Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert 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 worst condition.
Time frame: Baseline, Week 16
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Baseline | 3.39 units on a scale | Standard Deviation 0.57 |
| Placebo + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Change at Week 16 | -0.41 units on a scale | Standard Deviation 0.7 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Change at Week 16 | -0.49 units on a scale | Standard Deviation 0.74 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Baseline | 3.28 units on a scale | Standard Deviation 0.46 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Baseline | 3.43 units on a scale | Standard Deviation 0.56 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Change at Week 16 | -0.61 units on a scale | Standard Deviation 0.83 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Baseline | 3.37 units on a scale | Standard Deviation 0.55 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Change at Week 16 | -0.63 units on a scale | Standard Deviation 0.87 |
Comparison: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.02295% CI: [-0.32, -0.03]ANCOVA
Comparison: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.0295% CI: [-0.33, -0.03]ANCOVA
Comparison: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.00295% CI: [-0.4, -0.09]ANCOVA
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), 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 study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. Last observation carried forward (LOCF) method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.06 units on a scale | Standard Deviation 1.23 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -1.91 units on a scale | Standard Deviation 1.9 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -2.18 units on a scale | Standard Deviation 1.9 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 5.78 units on a scale | Standard Deviation 1.36 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 5.76 units on a scale | Standard Deviation 1.32 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -2.28 units on a scale | Standard Deviation 1.99 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 5.87 units on a scale | Standard Deviation 1.3 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -2.42 units on a scale | Standard Deviation 2.09 |
Comparison: LS means were estimated from the corresponding analysis of covariance (ANCOVA) model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.03995% CI: [-0.81, -0.02]ANCOVA
Comparison: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.01195% CI: [-0.91, -0.12]ANCOVA
Comparison: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.00595% CI: [-0.97, -0.17]ANCOVA
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time frame: Baseline, Week 16
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.24 units on a scale | Standard Deviation 1.45 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -1.76 units on a scale | Standard Deviation 1.78 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -2.11 units on a scale | Standard Deviation 1.99 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 5.86 units on a scale | Standard Deviation 1.51 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 5.90 units on a scale | Standard Deviation 1.22 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -2.23 units on a scale | Standard Deviation 1.99 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 5.91 units on a scale | Standard Deviation 1.36 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -2.35 units on a scale | Standard Deviation 2.07 |
Comparison: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.0195% CI: [-0.91, -0.12]ANCOVA
Comparison: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.00295% CI: [-1.03, -0.23]ANCOVA
Comparison: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-1.1, -0.3]ANCOVA
Secondary
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24
SF-36v2 was a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and role limitations due to emotional problems, bodily pain, general health, vitality, and mental health. The total score and the score for a section was an average of the individual question scores, which were scaled 0-100. Higher scores reflected better participant status and positive change indicated an improvement.
Time frame: Baseline, Week 12, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: General Health | 46.37 units on a scale | Standard Deviation 17.64 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Role Physical | 5.17 units on a scale | Standard Deviation 22.95 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Vitality | 3.80 units on a scale | Standard Deviation 14.82 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Bodily Pain | 32.99 units on a scale | Standard Deviation 13.77 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Vitality | 1.66 units on a scale | Standard Deviation 16.11 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Mental Health | 1.27 units on a scale | Standard Deviation 16.66 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Social Function | 5.02 units on a scale | Standard Deviation 22.39 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Vitality | 49.08 units on a scale | Standard Deviation 17.73 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Social Function | 61.02 units on a scale | Standard Deviation 23.59 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Physical Function | 7.36 units on a scale | Standard Deviation 18.33 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Role Emotional | 1.92 units on a scale | Standard Deviation 24.98 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Role Physical | 46.67 units on a scale | Standard Deviation 21.79 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Role Emotional | -0.55 units on a scale | Standard Deviation 25.48 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: General Health | 4.67 units on a scale | Standard Deviation 16.11 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Mental Health | 3.13 units on a scale | Standard Deviation 15.58 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Bodily Pain | 9.14 units on a scale | Standard Deviation 19.41 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Physical Function | 33.51 units on a scale | Standard Deviation 18.98 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Role Physical | 7.61 units on a scale | Standard Deviation 22.23 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: General Health | 2.41 units on a scale | Standard Deviation 16.95 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Bodily Pain | 8.76 units on a scale | Standard Deviation 16.79 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Social Function | 4.36 units on a scale | Standard Deviation 22.85 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Mental Health | 62.80 units on a scale | Standard Deviation 20.39 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Physical Function | 6.21 units on a scale | Standard Deviation 19.01 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Role Emotional | 68.15 units on a scale | Standard Deviation 26.16 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Physical Function | 8.78 units on a scale | Standard Deviation 22.64 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Role Physical | 8.41 units on a scale | Standard Deviation 22.77 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Bodily Pain | 12.54 units on a scale | Standard Deviation 21.4 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Mental Health | 66.57 units on a scale | Standard Deviation 17.12 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Role Physical | 47.44 units on a scale | Standard Deviation 20.65 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Vitality | 2.43 units on a scale | Standard Deviation 17.72 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Role Emotional | 0.69 units on a scale | Standard Deviation 23.91 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: General Health | 49.41 units on a scale | Standard Deviation 15.67 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Physical Function | 36.22 units on a scale | Standard Deviation 18.9 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Mental Health | 2.06 units on a scale | Standard Deviation 16.93 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Physical Function | 10.96 units on a scale | Standard Deviation 20.84 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Bodily Pain | 35.66 units on a scale | Standard Deviation 12.43 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Bodily Pain | 12.51 units on a scale | Standard Deviation 20.98 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Vitality | 4.23 units on a scale | Standard Deviation 16.17 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Social Function | 4.09 units on a scale | Standard Deviation 24.27 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Role Physical | 8.81 units on a scale | Standard Deviation 23.59 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Social Function | 6.25 units on a scale | Standard Deviation 20.55 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: General Health | 5.29 units on a scale | Standard Deviation 14.7 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Role Emotional | 2.24 units on a scale | Standard Deviation 24.4 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Social Function | 67.63 units on a scale | Standard Deviation 23.5 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Mental Health | 1.55 units on a scale | Standard Deviation 16.05 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Role Emotional | 68.96 units on a scale | Standard Deviation 24.22 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: General Health | 4.51 units on a scale | Standard Deviation 14.94 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Vitality | 52.22 units on a scale | Standard Deviation 16.82 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Mental Health | 1.63 units on a scale | Standard Deviation 16.1 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: General Health | 47.00 units on a scale | Standard Deviation 15.79 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Role Physical | 48.50 units on a scale | Standard Deviation 22.21 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Vitality | 53.00 units on a scale | Standard Deviation 17.89 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Social Function | 65.83 units on a scale | Standard Deviation 23.65 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Mental Health | 64.63 units on a scale | Standard Deviation 18.13 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Physical Function | 12.83 units on a scale | Standard Deviation 22.71 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Bodily Pain | 15.18 units on a scale | Standard Deviation 21.49 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Vitality | 3.79 units on a scale | Standard Deviation 18.57 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Social Function | 4.17 units on a scale | Standard Deviation 22.37 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Role Emotional | 2.17 units on a scale | Standard Deviation 29.05 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Mental Health | 2.20 units on a scale | Standard Deviation 16.18 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: General Health | 4.94 units on a scale | Standard Deviation 15.57 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Physical Function | 10.50 units on a scale | Standard Deviation 22.86 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Role Physical | 6.96 units on a scale | Standard Deviation 26.61 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Bodily Pain | 13.27 units on a scale | Standard Deviation 24.78 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Role Emotional | -1.33 units on a scale | Standard Deviation 28.95 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Physical Function | 34.70 units on a scale | Standard Deviation 16.56 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Bodily Pain | 33.95 units on a scale | Standard Deviation 14.15 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Role Emotional | 68.44 units on a scale | Standard Deviation 25.86 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: General Health | 6.55 units on a scale | Standard Deviation 13.94 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Role Physical | 7.71 units on a scale | Standard Deviation 23.45 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Vitality | 2.58 units on a scale | Standard Deviation 20.02 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Social Function | 3.67 units on a scale | Standard Deviation 24.04 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Role Physical | 5.91 units on a scale | Standard Deviation 27.38 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: General Health | 49.31 units on a scale | Standard Deviation 16.81 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Bodily Pain | 35.06 units on a scale | Standard Deviation 13.47 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Physical Function | 8.50 units on a scale | Standard Deviation 23.87 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: General Health | 3.08 units on a scale | Standard Deviation 18.02 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Mental Health | 1.66 units on a scale | Standard Deviation 16.15 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Vitality | 2.76 units on a scale | Standard Deviation 21.47 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Role Emotional | 69.77 units on a scale | Standard Deviation 24.82 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Mental Health | 65.48 units on a scale | Standard Deviation 17.86 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Role Emotional | -1.26 units on a scale | Standard Deviation 27.15 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Social Function | 4.22 units on a scale | Standard Deviation 22.59 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Social Function | 66.55 units on a scale | Standard Deviation 23.29 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: General Health | 4.96 units on a scale | Standard Deviation 16.27 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Vitality | 5.34 units on a scale | Standard Deviation 18.47 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Vitality | 51.29 units on a scale | Standard Deviation 18.21 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Role Physical | 8.49 units on a scale | Standard Deviation 25.63 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Bodily Pain | 12.76 units on a scale | Standard Deviation 22.62 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Mental Health | 0.45 units on a scale | Standard Deviation 18.7 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Role Emotional | -1.95 units on a scale | Standard Deviation 27.43 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 12: Physical Function | 9.90 units on a scale | Standard Deviation 22.6 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Physical Function | 36.52 units on a scale | Standard Deviation 18.46 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Social Function | 1.38 units on a scale | Standard Deviation 28.15 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Change at Week 24: Bodily Pain | 11.52 units on a scale | Standard Deviation 24.58 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | Baseline: Role Physical | 47.46 units on a scale | Standard Deviation 22.31 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24
SF-36v2: standardized survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, role limitations due to physical and emotional problems, bodily pain, general health, vitality, mental health). Total score for each aspect were scaled 0-100. Higher scores reflect better participant status and positive change indicated an improvement. 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 12 and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 12: Physical Component Score | 0.35 z-score | Standard Deviation 0.66 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 12: Mental Component Score | 0.08 z-score | Standard Deviation 0.92 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 24: Mental Component Score | -0.03 z-score | Standard Deviation 0.94 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Baseline: Mental Component Score | -0.30 z-score | Standard Deviation 1.16 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Baseline: Physical Component Score | -1.84 z-score | Standard Deviation 0.67 |
| Placebo + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 24: Physical Component Score | 0.32 z-score | Standard Deviation 0.76 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 24: Mental Component Score | -0.03 z-score | Standard Deviation 0.98 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Baseline: Physical Component Score | -1.76 z-score | Standard Deviation 0.64 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 12: Mental Component Score | 0.01 z-score | Standard Deviation 0.9 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 24: Physical Component Score | 0.45 z-score | Standard Deviation 0.76 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Baseline: Mental Component Score | -0.11 z-score | Standard Deviation 1.05 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 12: Physical Component Score | 0.50 z-score | Standard Deviation 0.76 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Baseline: Physical Component Score | -1.80 z-score | Standard Deviation 0.61 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 12: Mental Component Score | -0.03 z-score | Standard Deviation 0.96 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 24: Mental Component Score | -0.10 z-score | Standard Deviation 0.94 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 12: Physical Component Score | 0.56 z-score | Standard Deviation 0.73 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 24: Physical Component Score | 0.50 z-score | Standard Deviation 0.83 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Baseline: Mental Component Score | -0.17 z-score | Standard Deviation 1.09 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 24: Physical Component Score | 0.43 z-score | Standard Deviation 0.91 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 24: Mental Component Score | -0.14 z-score | Standard Deviation 1.1 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Baseline: Physical Component Score | -1.76 z-score | Standard Deviation 0.61 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 12: Physical Component Score | 0.51 z-score | Standard Deviation 0.86 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Change at Week 12: Mental Component Score | -0.06 z-score | Standard Deviation 1 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | Baseline: Mental Component Score | -0.15 z-score | Standard Deviation 1.12 |
Secondary
Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24
Participants were asked to assess index joint (knee/hip) pain during the past 24 hours on an 0-10 point integer scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline score was calculated as the mean of the scores in the index joint over the 3 days days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores in the index joint within each study week. The change from Baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score, where negative change indicated an improvement.
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Baseline | 6.31 units on a scale | Standard Deviation 1.39 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 16 | -1.53 units on a scale | Standard Deviation 1.82 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 12 | -1.49 units on a scale | Standard Deviation 1.75 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 6 | -1.38 units on a scale | Standard Deviation 1.58 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 1 | -0.55 units on a scale | Standard Deviation 1.12 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 8 | -1.41 units on a scale | Standard Deviation 1.64 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 4 | -1.28 units on a scale | Standard Deviation 1.65 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 3 | -1.19 units on a scale | Standard Deviation 1.65 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 2 | -0.95 units on a scale | Standard Deviation 1.43 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 24 | -1.65 units on a scale | Standard Deviation 1.89 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 20 | -1.61 units on a scale | Standard Deviation 1.85 |
| Placebo + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 10 | -1.41 units on a scale | Standard Deviation 1.77 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 10 | -1.79 units on a scale | Standard Deviation 1.88 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Baseline | 6.29 units on a scale | Standard Deviation 1.3 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 1 | -0.74 units on a scale | Standard Deviation 1.1 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 12 | -1.91 units on a scale | Standard Deviation 1.82 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 16 | -1.87 units on a scale | Standard Deviation 1.9 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 20 | -1.95 units on a scale | Standard Deviation 1.94 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 24 | -1.84 units on a scale | Standard Deviation 1.96 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 2 | -0.91 units on a scale | Standard Deviation 1.4 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 3 | -1.19 units on a scale | Standard Deviation 1.57 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 4 | -1.45 units on a scale | Standard Deviation 1.7 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 6 | -1.57 units on a scale | Standard Deviation 1.75 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 8 | -1.62 units on a scale | Standard Deviation 1.75 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 20 | -2.19 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 6 | -1.88 units on a scale | Standard Deviation 1.96 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Baseline | 6.38 units on a scale | Standard Deviation 1.48 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 24 | -2.07 units on a scale | Standard Deviation 2.31 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 12 | -2.06 units on a scale | Standard Deviation 2.19 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 2 | -1.28 units on a scale | Standard Deviation 1.76 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 8 | -1.84 units on a scale | Standard Deviation 2 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 3 | -1.40 units on a scale | Standard Deviation 1.73 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 1 | -1.22 units on a scale | Standard Deviation 1.49 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 4 | -1.77 units on a scale | Standard Deviation 1.74 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 16 | -2.07 units on a scale | Standard Deviation 2.25 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 10 | -2.09 units on a scale | Standard Deviation 2.13 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 16 | -2.15 units on a scale | Standard Deviation 2.04 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 8 | -1.80 units on a scale | Standard Deviation 1.83 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 6 | -1.69 units on a scale | Standard Deviation 1.71 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 4 | -1.44 units on a scale | Standard Deviation 1.73 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 24 | -2.03 units on a scale | Standard Deviation 2.08 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 3 | -1.08 units on a scale | Standard Deviation 1.58 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 12 | -2.06 units on a scale | Standard Deviation 1.86 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 10 | -2.06 units on a scale | Standard Deviation 1.82 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 2 | -1.03 units on a scale | Standard Deviation 1.46 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 1 | -0.96 units on a scale | Standard Deviation 1.22 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Baseline | 6.34 units on a scale | Standard Deviation 1.31 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Change at Week 20 | -2.15 units on a scale | Standard Deviation 2.07 |
Secondary
Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24
EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). EQ-5D summary index was obtained with a formula that weights each level of the dimensions. The index-based score was interpreted along a continuum of 0 (death) to 1 (perfect health). Negative change from baseline represented worsening.
Time frame: Baseline, Week 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure and 'number analyzed' signifies number of participants evaluable for each specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | Baseline: Index Score | 0.45 units on a scale | Standard Deviation 0.29 |
| Placebo + Diclofenac | Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | Change at Week 24: Index Score | 0.11 units on a scale | Standard Deviation 0.35 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | Change at Week 24: Index Score | 0.15 units on a scale | Standard Deviation 0.29 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | Baseline: Index Score | 0.48 units on a scale | Standard Deviation 0.25 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | Baseline: Index Score | 0.47 units on a scale | Standard Deviation 0.26 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | Change at Week 24: Index Score | 0.14 units on a scale | Standard Deviation 0.33 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | Baseline: Index Score | 0.47 units on a scale | Standard Deviation 0.27 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | Change at Week 24: Index Score | 0.16 units on a scale | Standard Deviation 0.31 |
Secondary
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24
Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert 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 worst condition.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 12 | -0.45 units on a scale | Standard Deviation 0.8 |
| Placebo + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 4 | -0.40 units on a scale | Standard Deviation 0.74 |
| Placebo + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 24 | -0.45 units on a scale | Standard Deviation 0.77 |
| Placebo + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 8 | -0.37 units on a scale | Standard Deviation 0.72 |
| Placebo + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 2 | -0.36 units on a scale | Standard Deviation 0.79 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 8 | -0.44 units on a scale | Standard Deviation 0.7 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 12 | -0.52 units on a scale | Standard Deviation 0.71 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 24 | -0.46 units on a scale | Standard Deviation 0.76 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 4 | -0.45 units on a scale | Standard Deviation 0.63 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 2 | -0.37 units on a scale | Standard Deviation 0.65 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 8 | -0.71 units on a scale | Standard Deviation 0.85 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 2 | -0.40 units on a scale | Standard Deviation 0.68 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 4 | -0.65 units on a scale | Standard Deviation 0.82 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 12 | -0.69 units on a scale | Standard Deviation 0.78 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 24 | -0.57 units on a scale | Standard Deviation 0.86 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 12 | -0.61 units on a scale | Standard Deviation 0.76 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 4 | -0.54 units on a scale | Standard Deviation 0.75 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 2 | -0.28 units on a scale | Standard Deviation 0.71 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 8 | -0.66 units on a scale | Standard Deviation 0.79 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 24 | -0.57 units on a scale | Standard Deviation 0.91 |
Comparison: At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.295% CI: [-0.22, 0.05]ANCOVA
Comparison: At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.75495% CI: [-0.15, 0.11]ANCOVA
Comparison: At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.44995% CI: [-0.08, 0.18]ANCOVA
Comparison: At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.06295% CI: [-0.27, 0.01]ANCOVA
Comparison: At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.00295% CI: [-0.36, -0.08]ANCOVA
Comparison: At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.02695% CI: [-0.3, -0.02]ANCOVA
Comparison: At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.03295% CI: [-0.31, -0.01]ANCOVA
Comparison: At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-0.48, -0.19]ANCOVA
Comparison: At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-0.45, -0.16]ANCOVA
Comparison: At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.03895% CI: [-0.3, -0.01]ANCOVA
Comparison: At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.00395% CI: [-0.37, -0.07]ANCOVA
Comparison: At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.01695% CI: [-0.33, -0.03]ANCOVA
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 12 | -1.81 units on a scale | Standard Deviation 1.59 |
| Placebo + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 4 | -1.51 units on a scale | Standard Deviation 1.55 |
| Placebo + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 24 | -1.81 units on a scale | Standard Deviation 1.91 |
| Placebo + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 8 | -1.63 units on a scale | Standard Deviation 1.54 |
| Placebo + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 2 | -1.30 units on a scale | Standard Deviation 1.43 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 8 | -1.88 units on a scale | Standard Deviation 1.68 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 12 | -2.23 units on a scale | Standard Deviation 1.82 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 24 | -2.11 units on a scale | Standard Deviation 2.08 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 4 | -1.76 units on a scale | Standard Deviation 1.65 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 2 | -1.22 units on a scale | Standard Deviation 1.52 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 8 | -2.22 units on a scale | Standard Deviation 1.92 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 2 | -1.21 units on a scale | Standard Deviation 1.67 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 4 | -2.12 units on a scale | Standard Deviation 1.7 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 12 | -2.50 units on a scale | Standard Deviation 2.03 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 24 | -2.24 units on a scale | Standard Deviation 2.23 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 12 | -2.42 units on a scale | Standard Deviation 2 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 4 | -1.93 units on a scale | Standard Deviation 1.71 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 2 | -0.86 units on a scale | Standard Deviation 1.57 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 8 | -2.34 units on a scale | Standard Deviation 1.92 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | Change at Week 24 | -2.19 units on a scale | Standard Deviation 2.16 |
Comparison: At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.95795% CI: [-0.32, 0.34]ANCOVA
Comparison: At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.89995% CI: [-0.31, 0.35]ANCOVA
Comparison: At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.02295% CI: [0.06, 0.72]ANCOVA
Comparison: At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.05295% CI: [-0.7, 0]ANCOVA
Comparison: At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-1.05, -0.34]ANCOVA
Comparison: At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.00895% CI: [-0.84, -0.13]ANCOVA
Comparison: At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.05895% CI: [-0.72, 0.01]ANCOVA
Comparison: At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-1.05, -0.32]ANCOVA
Comparison: At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-1.12, -0.38]ANCOVA
Comparison: At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.00795% CI: [-0.91, -0.15]ANCOVA
Comparison: At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-1.18, -0.41]ANCOVA
Comparison: At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-1.05, -0.28]ANCOVA
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 4 | -1.46 units on a scale | Standard Deviation 1.49 |
| Placebo + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 2 | -1.31 units on a scale | Standard Deviation 1.42 |
| Placebo + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 24 | -1.70 units on a scale | Standard Deviation 1.86 |
| Placebo + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 8 | -1.59 units on a scale | Standard Deviation 1.52 |
| Placebo + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 12 | -1.75 units on a scale | Standard Deviation 1.6 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 8 | -1.76 units on a scale | Standard Deviation 1.72 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 12 | -2.13 units on a scale | Standard Deviation 1.87 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 24 | -1.99 units on a scale | Standard Deviation 2.13 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 4 | -1.58 units on a scale | Standard Deviation 1.71 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 2 | -1.18 units on a scale | Standard Deviation 1.45 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 4 | -2.09 units on a scale | Standard Deviation 1.84 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 2 | -1.30 units on a scale | Standard Deviation 1.57 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 8 | -2.22 units on a scale | Standard Deviation 1.88 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 12 | -2.43 units on a scale | Standard Deviation 2.01 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 24 | -2.17 units on a scale | Standard Deviation 2.19 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 12 | -2.28 units on a scale | Standard Deviation 1.93 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 4 | -1.81 units on a scale | Standard Deviation 1.68 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 2 | -1.06 units on a scale | Standard Deviation 1.4 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 8 | -2.13 units on a scale | Standard Deviation 1.91 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | Change at Week 24 | -2.08 units on a scale | Standard Deviation 2.21 |
Comparison: At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.75495% CI: [-0.25, 0.35]ANCOVA
Comparison: At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.70695% CI: [-0.36, 0.25]ANCOVA
Comparison: At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.26695% CI: [-0.13, 0.48]ANCOVA
Comparison: At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.19595% CI: [-0.58, 0.12]ANCOVA
Comparison: At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-1.07, -0.36]ANCOVA
Comparison: At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.01995% CI: [-0.78, -0.07]ANCOVA
Comparison: At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.12695% CI: [-0.64, 0.08]ANCOVA
Comparison: At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-1.1, -0.37]ANCOVA
Comparison: At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.00195% CI: [-0.98, -0.25]ANCOVA
Comparison: At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.00795% CI: [-0.9, -0.15]ANCOVA
Comparison: At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: <0.00195% CI: [-1.21, -0.44]ANCOVA
Comparison: At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.p-value: 0.00195% CI: [-1.02, -0.25]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24
WOMAC Index: 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 the hip and/or knee. WOMAC average score is the mean of the WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, with higher score indicating worse response. Greater reduction in WOMAC average score indicated greater improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -1.45 units on a scale | Standard Deviation 1.47 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -1.74 units on a scale | Standard Deviation 1.83 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -1.59 units on a scale | Standard Deviation 1.51 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.31 units on a scale | Standard Deviation 1.36 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 6.05 units on a scale | Standard Deviation 1.31 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -1.74 units on a scale | Standard Deviation 1.56 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -1.80 units on a scale | Standard Deviation 1.78 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.19 units on a scale | Standard Deviation 1.93 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.05 units on a scale | Standard Deviation 2.06 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 5.75 units on a scale | Standard Deviation 1.43 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -1.68 units on a scale | Standard Deviation 1.68 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -1.83 units on a scale | Standard Deviation 1.67 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.23 units on a scale | Standard Deviation 1.44 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.24 units on a scale | Standard Deviation 1.82 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 5.72 units on a scale | Standard Deviation 1.19 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.16 units on a scale | Standard Deviation 2.16 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.22 units on a scale | Standard Deviation 1.93 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.45 units on a scale | Standard Deviation 1.97 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -2.14 units on a scale | Standard Deviation 1.74 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.30 units on a scale | Standard Deviation 1.52 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -2.21 units on a scale | Standard Deviation 1.86 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.17 units on a scale | Standard Deviation 2.09 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 5.80 units on a scale | Standard Deviation 1.32 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.06 units on a scale | Standard Deviation 1.45 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -1.92 units on a scale | Standard Deviation 1.7 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -2.27 units on a scale | Standard Deviation 1.84 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.42 units on a scale | Standard Deviation 1.89 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.43 units on a scale | Standard Deviation 2 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24
Participants answered the question: How much pain have you had when going up or down the stairs? Participants responded by using an 11-point scale, where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -1.58 units on a scale | Standard Deviation 1.89 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.03 units on a scale | Standard Deviation 1.98 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.38 units on a scale | Standard Deviation 1.83 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.00 units on a scale | Standard Deviation 2.13 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -1.95 units on a scale | Standard Deviation 2.24 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -1.78 units on a scale | Standard Deviation 1.81 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 7.24 units on a scale | Standard Deviation 1.57 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 7.04 units on a scale | Standard Deviation 1.65 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.49 units on a scale | Standard Deviation 1.72 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -2.10 units on a scale | Standard Deviation 2.17 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.54 units on a scale | Standard Deviation 2.22 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -2.15 units on a scale | Standard Deviation 2.03 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.54 units on a scale | Standard Deviation 2.25 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.44 units on a scale | Standard Deviation 2.47 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.55 units on a scale | Standard Deviation 1.94 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -2.39 units on a scale | Standard Deviation 2.13 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 7.05 units on a scale | Standard Deviation 1.63 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.53 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -2.51 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.86 units on a scale | Standard Deviation 2.51 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.53 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -2.64 units on a scale | Standard Deviation 2.32 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.21 units on a scale | Standard Deviation 1.78 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -2.10 units on a scale | Standard Deviation 2.01 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.79 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.56 units on a scale | Standard Deviation 2.5 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 7.06 units on a scale | Standard Deviation 1.62 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.77 units on a scale | Standard Deviation 2.36 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24
Participants answered the question: How much pain have you had when walking on a flat surface? Participants responded by using an 11-point scale where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.34 units on a scale | Standard Deviation 1.71 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -1.62 units on a scale | Standard Deviation 1.78 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -1.95 units on a scale | Standard Deviation 2.12 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 6.12 units on a scale | Standard Deviation 1.67 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -1.84 units on a scale | Standard Deviation 2.13 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -1.83 units on a scale | Standard Deviation 1.92 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -1.47 units on a scale | Standard Deviation 1.74 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 5.91 units on a scale | Standard Deviation 1.74 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.23 units on a scale | Standard Deviation 1.76 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -1.75 units on a scale | Standard Deviation 2.07 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -1.81 units on a scale | Standard Deviation 1.84 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.15 units on a scale | Standard Deviation 1.94 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.14 units on a scale | Standard Deviation 1.99 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.08 units on a scale | Standard Deviation 2.38 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -2.01 units on a scale | Standard Deviation 1.99 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -2.05 units on a scale | Standard Deviation 2.15 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.35 units on a scale | Standard Deviation 2.41 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.09 units on a scale | Standard Deviation 2.38 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.07 units on a scale | Standard Deviation 1.82 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 5.81 units on a scale | Standard Deviation 1.54 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.09 units on a scale | Standard Deviation 2.54 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.41 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -1.87 units on a scale | Standard Deviation 1.96 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -2.25 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -0.89 units on a scale | Standard Deviation 1.86 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.10 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.34 units on a scale | Standard Deviation 2.52 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 5.99 units on a scale | Standard Deviation 1.71 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee/hip. Negative change indicated an improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -1.72 units on a scale | Standard Deviation 2.11 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.31 units on a scale | Standard Deviation 1.75 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -1.37 units on a scale | Standard Deviation 1.83 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -1.56 units on a scale | Standard Deviation 1.89 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -1.66 units on a scale | Standard Deviation 1.94 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -1.70 units on a scale | Standard Deviation 2.17 |
| Placebo + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 5.84 units on a scale | Standard Deviation 1.78 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.29 units on a scale | Standard Deviation 1.82 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.36 units on a scale | Standard Deviation 2.16 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 5.61 units on a scale | Standard Deviation 1.85 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.27 units on a scale | Standard Deviation 2.33 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -1.71 units on a scale | Standard Deviation 2.14 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -1.86 units on a scale | Standard Deviation 2.07 |
| Tanezumab 2.5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.06 units on a scale | Standard Deviation 2.35 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.42 units on a scale | Standard Deviation 2.27 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 5.51 units on a scale | Standard Deviation 1.52 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -2.20 units on a scale | Standard Deviation 2.18 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.08 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.38 units on a scale | Standard Deviation 1.77 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -2.21 units on a scale | Standard Deviation 2.07 |
| Tanezumab 5 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.15 units on a scale | Standard Deviation 2.23 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 2 | -1.27 units on a scale | Standard Deviation 1.91 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 4 | -2.01 units on a scale | Standard Deviation 2.16 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 8 | -2.34 units on a scale | Standard Deviation 2.22 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 12 | -2.55 units on a scale | Standard Deviation 2.22 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 16 | -2.53 units on a scale | Standard Deviation 2.26 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Baseline | 5.60 units on a scale | Standard Deviation 1.78 |
| Tanezumab 10 mg + Diclofenac | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | Change at Week 24 | -2.22 units on a scale | Standard Deviation 2.34 |
Secondary
Number of Participants Who Discontinued Due to Lack of Efficacy
Number of participants who discontinued due to lack of efficacy were reported.
Time frame: Baseline up to end of study (Week 32)
Population: The ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo + Diclofenac | Number of Participants Who Discontinued Due to Lack of Efficacy | 9 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants Who Discontinued Due to Lack of Efficacy | 3 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants Who Discontinued Due to Lack of Efficacy | 7 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants Who Discontinued Due to Lack of Efficacy | 2 Participants |
Secondary
Number of Participants With 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. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Time frame: Baseline up to 112 days after last intravenous dose (up to Week 32)
Population: The ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo + Diclofenac | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 8 Participants |
| Placebo + Diclofenac | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 53 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 12 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 71 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 73 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 8 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 10 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 72 Participants |
Secondary
Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24
EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). Baseline EQ-5D individual health state profile was determined as number of participants no dysfunction, moderate or some dysfunction and extreme dysfunction and change from baseline in EQ-5D individual health state profile was determined as number of participants improved, no change or worsened.
Time frame: Baseline, Week 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-No Dysfunction | 65 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-No Change | 106 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-Improved | 27 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-No Dysfunction | 8 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-Worsened | 8 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-No Change | 116 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-Improved | 21 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-Extreme Dysfunction | 6 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-Improved | 19 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-Improved | 28 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-Worsened | 15 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-Moderate Dysfunction | 72 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-Worsened | 11 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-Moderate Dysfunction | 87 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-Improved | 16 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-Extreme Dysfunction | 0 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-No Change | 118 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-No Dysfunction | 74 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-Extreme Dysfunction | 38 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-No Dysfunction | 25 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-No Change | 125 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-No Dysfunction | 0 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-Moderate Dysfunction | 116 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-Worsened | 4 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-Extreme Dysfunction | 1 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-Extreme Dysfunction | 11 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-No Change | 127 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-Moderate Dysfunction | 143 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-Worsened | 19 Participants |
| Placebo + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-Moderate Dysfunction | 114 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-No Change | 111 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-Moderate Dysfunction | 148 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-Extreme Dysfunction | 1 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-No Dysfunction | 61 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-Moderate Dysfunction | 92 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-Extreme Dysfunction | 3 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-No Dysfunction | 13 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-Moderate Dysfunction | 141 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-Extreme Dysfunction | 2 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-Moderate Dysfunction | 125 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-Extreme Dysfunction | 2 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-Improved | 25 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-Worsened | 11 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-No Change | 125 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-Worsened | 4 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-Improved | 29 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-No Change | 125 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-Worsened | 2 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-Improved | 26 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-Worsened | 19 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-No Dysfunction | 7 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-No Dysfunction | 0 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-Extreme Dysfunction | 31 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-No Dysfunction | 82 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-Moderate Dysfunction | 72 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-No Change | 129 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-Worsened | 2 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-Improved | 33 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-No Change | 112 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-Improved | 27 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-No Change | 106 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-Improved | 32 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-Improved | 28 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-No Change | 109 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-Worsened | 13 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-Extreme Dysfunction | 4 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-Moderate Dysfunction | 96 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-Moderate Dysfunction | 126 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-No Dysfunction | 20 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-No Dysfunction | 2 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-Moderate Dysfunction | 115 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-No Change | 110 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-Extreme Dysfunction | 33 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-Extreme Dysfunction | 1 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-Moderate Dysfunction | 136 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-No Dysfunction | 70 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-No Dysfunction | 14 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-Moderate Dysfunction | 75 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-No Dysfunction | 53 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-Improved | 30 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-Improved | 31 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-No Change | 114 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-Extreme Dysfunction | 0 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-Worsened | 7 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-Worsened | 8 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-Worsened | 13 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-Worsened | 6 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-Improved | 34 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-No Change | 109 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-Extreme Dysfunction | 5 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-No Dysfunction | 10 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-Worsened | 7 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-No Dysfunction | 73 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-No Change | 105 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-No Dysfunction | 52 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-Improved | 19 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-Moderate Dysfunction | 111 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-No Change | 111 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-No Change | 107 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-Extreme Dysfunction | 4 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-Improved | 30 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-Extreme Dysfunction | 6 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Anxiety/Depression-Worsened | 19 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-Moderate Dysfunction | 135 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Anxiety/Depression-Moderate Dysfunction | 66 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-Moderate Dysfunction | 123 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-Improved | 27 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-Moderate Dysfunction | 92 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Usual Activities-No Dysfunction | 18 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-Worsened | 0 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-Improved | 25 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Pain/Discomfort-Improved | 33 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Mobility-Extreme Dysfunction | 0 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-No Dysfunction | 1 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Usual Activities-Worsened | 7 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Self Care-Extreme Dysfunction | 1 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-No Change | 104 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Mobility-No Change | 120 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Baseline: Pain/Discomfort-Extreme Dysfunction | 33 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | Change at Week 24: Self Care-Worsened | 11 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; LOCF
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. Percentage of participants with reduction in WOMAC pain intensity of at least (\>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16, 24 and 32 compared to baseline were classified as responders to WOMAC pain subscale and are reported here.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + Diclofenac | 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; LOCF | Week 24: At least 70% reduction | 12.5 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 24: At least 30% reduction | 48.0 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 4: At least 90% reduction | 2.0 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 4: At least 70% reduction | 5.9 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 12: At least 70% reduction | 7.2 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 4: At least 50% reduction | 17.1 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 4: At least 30% reduction | 42.1 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 24: At least 90% reduction | 3.9 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 16: At least 30% reduction | 50.0 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 2: At least 30% reduction | 30.3 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 16: At least 90% reduction | 2.0 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 12: At least 90% reduction | 2.0 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 12: At least 50% reduction | 27.0 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 2: At least 50% reduction | 13.8 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 16: At least 70% reduction | 13.2 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 12: At least 30% reduction | 48.7 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 8: At least 90% reduction | 2.0 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 2: At least 70% reduction | 4.6 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 16: At least 50% reduction | 30.9 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 8: At least 70% reduction | 3.9 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 8: At least 50% reduction | 25.0 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 2: At least 90% reduction | 2.0 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 24: At least 50% reduction | 28.3 percentage of participants |
| Placebo + Diclofenac | 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; LOCF | Week 8: At least 30% reduction | 43.4 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 4: At least 50% reduction | 26.9 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 24: At least 30% reduction | 58.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 24: At least 50% reduction | 38.5 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 2: At least 30% reduction | 28.8 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 2: At least 50% reduction | 16.0 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 2: At least 70% reduction | 6.4 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 2: At least 90% reduction | 1.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 24: At least 70% reduction | 18.6 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 4: At least 30% reduction | 51.9 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 4: At least 70% reduction | 10.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 24: At least 90% reduction | 8.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 4: At least 90% reduction | 1.9 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 8: At least 30% reduction | 51.9 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 8: At least 50% reduction | 27.6 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 8: At least 70% reduction | 9.6 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 8: At least 90% reduction | 5.1 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 12: At least 30% reduction | 57.1 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 12: At least 50% reduction | 36.5 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 12: At least 70% reduction | 16.7 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 12: At least 90% reduction | 6.4 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 16: At least 30% reduction | 54.5 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 16: At least 50% reduction | 35.9 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 16: At least 70% reduction | 17.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | 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; LOCF | Week 16: At least 90% reduction | 5.8 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 24: At least 90% reduction | 8.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 16: At least 70% reduction | 20.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 12: At least 70% reduction | 24.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 8: At least 50% reduction | 38.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 2: At least 30% reduction | 32.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 8: At least 30% reduction | 57.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 12: At least 90% reduction | 8.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 8: At least 90% reduction | 4.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 24: At least 50% reduction | 40.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 4: At least 30% reduction | 57.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 2: At least 70% reduction | 7.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 2: At least 50% reduction | 16.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 24: At least 30% reduction | 59.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 4: At least 50% reduction | 34.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 12: At least 30% reduction | 64.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 24: At least 70% reduction | 22.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 16: At least 50% reduction | 40.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 4: At least 70% reduction | 12.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 8: At least 70% reduction | 17.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 16: At least 30% reduction | 61.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 2: At least 90% reduction | 1.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 16: At least 90% reduction | 6.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 4: At least 90% reduction | 6.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | 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; LOCF | Week 12: At least 50% reduction | 46.7 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 4: At least 90% reduction | 2.1 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 24: At least 30% reduction | 59.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 8: At least 30% reduction | 63.4 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 2: At least 70% reduction | 2.8 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 16: At least 90% reduction | 6.9 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 8: At least 50% reduction | 38.6 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 8: At least 70% reduction | 19.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 2: At least 50% reduction | 9.0 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 16: At least 50% reduction | 49.0 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 8: At least 90% reduction | 6.2 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 12: At least 30% reduction | 63.4 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 2: At least 30% reduction | 24.1 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 12: At least 50% reduction | 42.8 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 12: At least 70% reduction | 24.8 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 16: At least 70% reduction | 19.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 12: At least 90% reduction | 4.8 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 4: At least 30% reduction | 50.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 24: At least 70% reduction | 21.4 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 2: At least 90% reduction | 0.7 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 4: At least 50% reduction | 30.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 24: At least 90% reduction | 8.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 4: At least 70% reduction | 11.7 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 16: At least 30% reduction | 66.2 percentage of participants |
| Tanezumab 10 mg + Diclofenac | 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; LOCF | Week 24: At least 50% reduction | 42.1 percentage of participants |
Secondary
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. Percentage of participants with cumulative reduction (as percent) (greater than 0%; \>= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16 and 24 were reported.
Time frame: Baseline, Week 16 and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here ' overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=20% reduction | 61.8 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=80% reduction | 6.6 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=90% reduction | 2.0 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: Greater than 0% reduction | 81.6 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=30% reduction | 50.0 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=60% reduction | 21.7 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=70% reduction | 13.2 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=50% reduction | 30.9 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=40% reduction | 38.8 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=70% reduction | 12.5 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=60% reduction | 20.4 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=80% reduction | 5.9 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=50% reduction | 28.3 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=40% reduction | 35.5 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=30% reduction | 48.0 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=20% reduction | 60.5 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: Greater than 0% reduction | 84.2 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: 100% reduction | 0.7 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=10% reduction | 73.7 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=90% reduction | 3.9 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=10% reduction | 72.4 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: 100% reduction | 0.7 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=40% reduction | 48.7 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=60% reduction | 26.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=80% reduction | 9.0 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: 100% reduction | 2.6 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: Greater than 0% reduction | 82.7 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: Greater than 0% reduction | 88.5 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=10% reduction | 82.7 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=20% reduction | 69.9 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=30% reduction | 54.5 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=50% reduction | 35.9 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=70% reduction | 17.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=90% reduction | 5.8 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=10% reduction | 76.9 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=20% reduction | 67.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=30% reduction | 58.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=40% reduction | 47.4 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=50% reduction | 38.5 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=60% reduction | 26.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=70% reduction | 18.6 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=80% reduction | 11.5 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=90% reduction | 8.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: 100% reduction | 3.8 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=80% reduction | 14.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=90% reduction | 6.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=10% reduction | 76.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: 100% reduction | 3.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=10% reduction | 74.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=20% reduction | 68.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=20% reduction | 65.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: Greater than 0% reduction | 88.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=30% reduction | 59.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=80% reduction | 10.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=40% reduction | 47.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: Greater than 0% reduction | 82.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=50% reduction | 40.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=60% reduction | 34.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: 100% reduction | 2.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=90% reduction | 8.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=70% reduction | 22.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=30% reduction | 61.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=50% reduction | 40.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=40% reduction | 50.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=60% reduction | 28.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=70% reduction | 20.0 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: 100% reduction | 2.8 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=80% reduction | 13.8 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=90% reduction | 6.9 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=10% reduction | 77.9 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: Greater than 0% reduction | 84.8 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=50% reduction | 42.1 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: 100% reduction | 2.8 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=60% reduction | 31.7 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=10% reduction | 75.2 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: Greater than 0% reduction | 84.1 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=70% reduction | 19.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=60% reduction | 31.7 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=20% reduction | 69.7 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=50% reduction | 49.0 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=80% reduction | 13.8 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=40% reduction | 60.7 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=30% reduction | 59.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=90% reduction | 8.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=30% reduction | 66.2 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 16: >=20% reduction | 75.2 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=40% reduction | 51.0 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | Week 24: >=70% reduction | 21.4 percentage of participants |
Secondary
Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF)
Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert 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 worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicates improvement.
Time frame: Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. BOCF method was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 16 | 4.6 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 2 | 5.9 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 8 | 5.3 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 12 | 6.6 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 4 | 6.6 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 24 | 5.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 12 | 6.4 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 2 | 5.8 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 4 | 3.2 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 8 | 6.4 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 24 | 4.5 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 16 | 5.8 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 24 | 10.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 4 | 14.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 12 | 13.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 16 | 14.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 2 | 4.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 8 | 17.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 4 | 11.7 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 8 | 13.8 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 24 | 9.7 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 16 | 14.5 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 12 | 10.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Week 2 | 5.5 percentage of participants |
Secondary
Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF
Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert 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 worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicated improvement.
Time frame: Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 16 | 4.6 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 12 | 6.6 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 24 | 5.9 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 2 | 5.9 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 4 | 6.6 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 8 | 5.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 12 | 6.4 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 4 | 3.2 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 16 | 5.8 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 8 | 6.4 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 24 | 5.8 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 2 | 5.8 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 24 | 12.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 2 | 4.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 12 | 14.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 4 | 14.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 16 | 14.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 8 | 18.0 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 4 | 12.4 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 8 | 14.5 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 24 | 12.4 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 2 | 5.5 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 12 | 12.4 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Week 16 | 16.6 percentage of participants |
Secondary
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF
OMERACT-OARSI responder: participant has \>=50 percent (%) change and \>=2 absolute change from Baseline in either WOMAC pain or physical function subscale scores or at least 2 of the following being true: \>=20% change and \>=1 absolute change from Baseline in WOMAC pain subscale; \>=20% change and \>=1 absolute change from Baseline in the WOMAC physical function subscale; \>=20% change and \>=1 absolute change from Baseline in PGA of osteoarthritis. WOMAC pain and physical function score: 0 to 10 with higher score = worse response. PGA score: 1 = very good and 5 = very poor.
Time frame: Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 2 | 44.7 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 4 | 51.3 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 8 | 57.2 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 12 | 60.5 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 16 | 57.9 percentage of participants |
| Placebo + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 24 | 55.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 24 | 65.4 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 12 | 67.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 2 | 37.2 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 8 | 58.3 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 4 | 57.1 percentage of participants |
| Tanezumab 2.5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 16 | 66.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 4 | 65.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 8 | 68.0 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 12 | 73.3 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 24 | 64.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 16 | 66.7 percentage of participants |
| Tanezumab 5 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 2 | 43.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 16 | 72.4 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 24 | 67.6 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 4 | 59.3 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 12 | 73.1 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 2 | 34.5 percentage of participants |
| Tanezumab 10 mg + Diclofenac | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | Week 8 | 69.7 percentage of participants |
Secondary
Time to Discontinuation (TTD) Due to Lack of Efficacy
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Time frame: Baseline up to Week 16 and 24
Population: The ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo + Diclofenac | Time to Discontinuation (TTD) Due to Lack of Efficacy | Week 16 | NA days |
| Placebo + Diclofenac | Time to Discontinuation (TTD) Due to Lack of Efficacy | Week 24 | NA days |
| Tanezumab 2.5 mg + Diclofenac | Time to Discontinuation (TTD) Due to Lack of Efficacy | Week 24 | NA days |
| Tanezumab 2.5 mg + Diclofenac | Time to Discontinuation (TTD) Due to Lack of Efficacy | Week 16 | NA days |
| Tanezumab 5 mg + Diclofenac | Time to Discontinuation (TTD) Due to Lack of Efficacy | Week 16 | NA days |
| Tanezumab 5 mg + Diclofenac | Time to Discontinuation (TTD) Due to Lack of Efficacy | Week 24 | NA days |
| Tanezumab 10 mg + Diclofenac | Time to Discontinuation (TTD) Due to Lack of Efficacy | Week 16 | NA days |
| Tanezumab 10 mg + Diclofenac | Time to Discontinuation (TTD) Due to Lack of Efficacy | Week 24 | NA days |
Other Pre-specified
Number of Participants With Intravenous Doses of Study Medication
Number of participants were reported based on the maximum number of intravenous (IV) doses of either tanezumab or placebo received.
Time frame: Day 1 up to Week 16
Population: The ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 1 | 14 Participants |
| Placebo + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 3 | 100 Participants |
| Placebo + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 2 | 38 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 1 | 9 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 3 | 114 Participants |
| Tanezumab 2.5 mg + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 2 | 34 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 2 | 26 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 1 | 15 Participants |
| Tanezumab 5 mg + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 3 | 109 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 1 | 13 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 3 | 101 Participants |
| Tanezumab 10 mg + Diclofenac | Number of Participants With Intravenous Doses of Study Medication | Number of IV Doses: 2 | 31 Participants |