Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, pain, tanezumab.
Brief summary
Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions. The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy benefits with a favorable safety profile when administered intravenously in previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg dose based on data from previous studies.
Detailed description
This is a randomized, double blind, placebo controlled, parallel group multicenter Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for 24 weeks compared to placebo in subjects with osteoarthritis of the knee or hip. A total of approximately 810 subjects will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (ie, 270/group). The randomization will be stratified by index joint (hip or knee), and most severe Kellgren-Lawrence grade (of any knee or hip joint) at study entry (grade 2, 3 or 4). Subjects will receive up to three SC doses of one of the following treatments at an 8-week interval between each injection: 1. tanezumab 2.5 mg; 2. tanezumab 5 mg; 3. Placebo to match tanezumab. The study is designed with a total (post-randomization) duration of 48 weeks and will consist of three periods: Screening (up to 37 days), Double-blind Treatment (24 weeks) and Safety Follow-up (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting a minimum of 2 days for all prohibited pain medications), if required, and an Initial Pain Assessment Period (the 7 days prior to Randomization/Baseline). Week 24 is the landmark analysis in this study. Subjects who do not complete the Double-blind Treatment period will enter and complete the 24-week Early-termination follow-up period.
Interventions
DRUGTanezumab
2.5 mg
DRUGPlacebo
Placebo
Sponsors
Eli Lilly and Company
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence x-ray Grade of at least 2 as diagnosed by the Central Reader * A history of insufficient pain relief from acetaminophen along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking NSAIDs, and tramadol or opioid treatments. * WOMAC Pain subscale score of at least 5 in the index hip or knee at Screening. * Be willing to discontinue all non study pain medications for osteoarthritis and not use prohibited pain medications throughout the duration of the study. * Female subjects of childbearing potential must agree to comply with protocol specified contraceptive requirements.
Exclusion criteria
* Subjects exceeding protocol defined BMI or body weight limits. * History of other diseases specified in the protocol (e.g. inflammatory joint diseases, crystalline diseases such as gout or pseudogout) that may involve the index joint and that could interfere with efficacy assessments. * Radiographic evidence of protocol specified bone or joint conditions in any screening radiograph as determined by the central radiology reviewer. * A history of osteonecrosis or osteoporotic fracture. * History of significant trauma or surgery to a knee, hip or shoulder within the previous year. * Planned surgical procedure during the duration of the study. * Presence of conditions (e.g. fibromyalgia, radiculopathy) associated with moderate to severe pain that may confound assessments or self evaluation of osteoarthritis pain. * Signs or symptoms of carpal tunnel syndrome in the year prior to Screening. * Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required. * History of intolerance or hypersensitivity to acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen is contraindicated. * Use of prohibited medications without the appropriate washout period prior to Screening or Initial Pain Assessment Period. * History of cancer within 5 years of Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision. * Subjects with signs and symptoms of clinically significant cardiac disease as described in the protocol. * Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities. * History, diagnosis, or signs and symptoms of clinically significant neurological disease such as but not limited to peripheral or autonomic neuropathy. * History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder. * History of known alcohol, analgesic or drug abuse within 2 years of Screening. * Previous exposure to exogenous NGF or to an anti-NGF antibody. * History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein. * Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening. * Evidence of protocol defined orthostatic hypotension at Screening. * Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening. * Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits. * Presence of drugs of abuse in screening urine toxicology panel. * Positive hepatitis B, hepatitis C or HIV test results indicative of current infection. * Participation in other investigational drug studies within protocol defined time limits. * Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline, Week 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). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline, Week 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. |
| Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Week 24 | Baseline, Week 24 | PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32 | Baseline, Week 32 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. |
| Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Baseline, Weeks 2, 4, 8, 12 and 16 | PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom 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 and inability to carry out all normal activities). |
| Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32 | Baseline, Week 32 | PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worse condition. |
| Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Weeks 2, 4, 8, 12, 16, 24 and 32 | Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was greater than or equal to (\>=) 50 percent and \>= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and PGA of OA (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF). |
| Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Baseline, Weeks 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. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. 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, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF. |
| Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2, 4, 8, 12, 16, 24 and 32 | 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. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF. |
| Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Weeks 2, 4, 8, 12, 16, 24 and 32 | Percentage of participants with reduction in WOMAC physical function 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 physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF. |
| Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Baseline, Weeks 16 and 24 | Percentage of participants with cumulative reduction (as percent) (greater than 0 %; \>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; =100 %) in WOMAC physical function subscale from Baseline to Weeks 16 and 24 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF. |
| Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Weeks 2, 4, 8, 12, 16, 24 and 32 | PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from Baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF. |
| Change From Baseline for Average Pain Score in the Index Joint 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 assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 8-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score. |
| Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32 | Baseline, Weeks 28 and 32 | Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 8-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale 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. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32 | Baseline, Week 32 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on a NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. |
| 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: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32 | Baseline, Week 32 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response. |
| 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, 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 in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Number of Participants Who Withdrew Due to Lack of Efficacy | Baseline up to Week 24 | Number of participants who withdrew from treatment due to lack of efficacy have been reported here. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 32 | Baseline, Week 32 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| 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 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32 | Baseline, Week 32 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Baseline | WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. |
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Baseline, Weeks 8, 16 and 24 | WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. |
| European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline, Weeks 8, 16 and 24 | EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions. |
| European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Baseline, Weeks 8, 16 and 24 | EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than equal to (\<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions. |
| Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Weeks 16 and 24 | The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. For participant satisfaction, participants responded using interactive response technology (IRT) on a 5 point likert scale from 1-5, where 1=extremely dissatisfied, 2=dissatisfied, 3=neither satisfied nor dissatisfied, 4=satisfied and 5=extremely satisfied. Higher scores indicated greater satisfaction. |
| Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Weeks 16 and 24 | The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess previous treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. |
| Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Weeks 16 and 24 | The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using interactive response technology (IRT) on a 5 point likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product. |
| Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Weeks 16 and 24 | The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess Patient willingness to use drug again, participants responded using interactive response technology (IRT) on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. |
| Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline, Weeks 32 and 48 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Visits of services directly related to osteoarthritis evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner. |
| Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Baseline, Weeks 32 and 48 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of participants who visited the emergency room due to osteoarthritis. |
| Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline, Weeks 32 and 48 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of visits to the emergency room due to OA. |
| Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline, Weeks 32 and 48 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of participants who were hospitalized due to OA. |
| Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Baseline, Weeks 32 and 48 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of nights stayed in the hospital due to OA. |
| Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline, Weeks 32 and 48 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices. |
| Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Baseline, Weeks 32 and 48 | Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 32 and Week 48. Domain evaluated was number of participants who quit job due to OA. |
| Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline, Weeks 32 and 48 | Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 32 and Week 48. Domain evaluated was duration since quitting job due to OA. |
| Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 24 | Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy. |
| Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Weeks 2, 4, 8, 12, 16 and 24 | In case of inadequate pain relief, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication between day 1 and week 24. Number of participants with any use of rescue medication during the particular study week were summarized. |
| Number of Participants Who Took Rescue Medication During Week 32 | Week 32 | In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during the 4 weeks up to and including the particular study week were summarized. |
| Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Weeks 2, 4, 8, 12, 16 and 24 | In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week a could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized. |
| Number of Days of Rescue Medication Used at Week 32 | Week 32 | In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days per week the participants used the rescue medication during the 4 weeks up to and including the particular study week were summarized. |
| Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Weeks 2, 4, 8, 12, 16 and 24 | In case of inadequate pain relief, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | Baseline up to Week 48 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to week 48 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. |
| Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | Baseline up to Week 48 | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to week 48 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator. |
| Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Baseline, Week 24 | The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact. |
| Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | Baseline up to Week 48 | Primary Abnormality criteria: HGB, hematocrit, RBC count \<0.8\* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width \<0.9\*LLN, \>1.1\*upper limit of normal(ULN); platelets \<0.5\*LLN,\>1.75\*ULN; WBC count\<0.6\*LLN, \>1.5\*ULN; Lymphocytes,Leukocytes,Neutrophils \<0.8\*LLN, \>1.2\*ULN; Basophils,Eosinophils,Monocytes\>1.2\*ULN; Prothrombin time/Intl. normalized ratio\>1.1\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides \>1.3\*ULN; Urate\>1.2\*ULN; sodium\<0.95\*LLN,\>1.05\*ULN; potassium,chloride,calcium,magnesium,bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate\<0.8\*LLN, \>1.2\*ULN; glucose\<0.6\*LLN, \>1.5\*ULN; HGB A1C \>1.3\*ULN; creatine kinase\>2.0\*ULN, specific gravity\<1.003, \>1.030; pH\<4.5, \>8; Urine Glucose, protein,HGB,bilirubin \>=1; Ketones\>=1;Urine erythrocytes,Leukocytes\>=20. |
| Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | Baseline up to Week 48 | Primary Abnormality criteria: hemoglobin; hematocrit; RBC count \< 0.8\*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*ULN; platelets \<0.5\*LLN,\>1.75\*upper limit of normal (ULN); white blood cell count\<0.6\*LLN, \>1.5\*ULN; Lymphocytes, Leukocytes, Neutrophils \<0.8\*LLN, \>1.2\*ULN; Basophils, Eosinophils, Monocytes \>1.2\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides \>1.3\*ULN; Urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN; Nitrite \>=1. |
| Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP). |
| Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Baseline, Weeks 2, 4, 8, 12,16, 24, 32 and 48 | Heart rate was measured at sitting position. |
| Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | Baseline, Weeks 24 and 48 | A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, QTcF, RR intervals) were collected. |
| Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48 | Baseline, Weeks 24 and 48 | Heart rate was measured at sitting position. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Baseline, Weeks 2, 4, 8, 12 and 16 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Percentage of Participants With Total Joint Replacements | Baseline up to Week 48 | Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery. |
| Number of Participants With Confirmed Orthostatic Hypotension | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP \<=150 mmHg (mean supine): Reduction in systolic BP\>=20 mmHg or reduction in diastolic BP\>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP \>150 mmHg (mean supine): Reduction in systolic BP\>=30 mmHg or reduction in diastolic BP\>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment. |
| Number of Participants With Anti Tanezumab Antibodies | Baseline, Weeks 8,16, 24, 32 and 48 | Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Participants listed as having anti-tanezumab antibodies had ADA titer level \>=3.32. Less than 3.32 was considered below the limit of quantitation. |
| Percentage of Participants With Adjudicated Joint Safety Outcomes | Baseline up to Week 48 | Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive OA (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32 | Baseline, Week 32 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Baseline, Weeks 2, 4, 8, 12 and 16 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. |
Countries
Austria, Bulgaria, Finland, France, Germany, Hungary, Italy, Japan, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16. | 282 |
| Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16. | 283 |
| Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 mg injection administered subcutaneously on Day 1 (Baseline), Week 8 and Week 16. | 284 |
| Total | 849 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 5 | 3 |
| Overall Study | Death | 0 | 0 | 2 |
| Overall Study | Insufficient clinical response | 7 | 3 | 3 |
| Overall Study | Lost to Follow-up | 3 | 2 | 2 |
| Overall Study | Other | 0 | 2 | 3 |
| Overall Study | Withdrawal by Subject | 32 | 22 | 32 |
Baseline characteristics
| Characteristic | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 64.24 years STANDARD_DEVIATION 9.58 | 65.17 years STANDARD_DEVIATION 8.39 | 65.23 years STANDARD_DEVIATION 10.16 | 64.88 years STANDARD_DEVIATION 9.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 19 Participants | 10 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 263 Participants | 264 Participants | 274 Participants | 801 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 34 Participants | 38 Participants | 34 Participants | 106 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 247 Participants | 245 Participants | 248 Participants | 740 Participants |
| Sex: Female, Male Female | 196 Participants | 198 Participants | 193 Participants | 587 Participants |
| Sex: Female, Male Male | 86 Participants | 85 Participants | 91 Participants | 262 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 282 | 1 / 283 | 2 / 284 |
| other Total, other adverse events | 77 / 282 | 73 / 283 | 60 / 284 |
| serious Total, serious adverse events | 3 / 282 | 8 / 283 | 9 / 284 |
Outcome results
Primary
Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Week 24
PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Time frame: Baseline, Week 24
Population: The intent to treat population was defined as all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Week 24 | -0.72 units on a scale | Standard Error 0.06 |
| Tanezumab 2.5 mg | Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Week 24 | -0.82 units on a scale | Standard Error 0.06 |
| Tanezumab 5 mg | Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Week 24 | -0.90 units on a scale | Standard Error 0.06 |
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.109295% CI: [-0.24, 0.02]ANCOVA
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.005195% CI: [-0.32, -0.06]ANCOVA
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 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). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Week 24
Population: The intent to treat (ITT) population included all randomized participants who received at least one dose of subcutaneous (SC) study medication (either tanezumab or placebo).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | -2.24 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | -2.70 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | -2.85 units on a scale | Standard Error 0.17 |
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.008895% CI: [-0.81, -0.12]ANCOVA
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000695% CI: [-0.97, -0.26]ANCOVA
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Time frame: Baseline, Week 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | -2.11 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | -2.70 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | -2.82 units on a scale | Standard Error 0.17 |
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000895% CI: [-0.93, -0.24]ANCOVA
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.05, -0.36]ANCOVA
Secondary
Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24
In case of inadequate pain relief, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.
Time frame: Weeks 2, 4, 8, 12, 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 2 | 3690.6 milligrams | Standard Error 714.3 |
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 4 | 3139.0 milligrams | Standard Error 707.35 |
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 8 | 2940.9 milligrams | Standard Error 678.61 |
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 12 | 2893.1 milligrams | Standard Error 749.38 |
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 16 | 2627.1 milligrams | Standard Error 658.47 |
| Placebo | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 24 | 2273.8 milligrams | Standard Error 625.84 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 24 | 1868.1 milligrams | Standard Error 482.13 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 2 | 2283.4 milligrams | Standard Error 444.56 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 12 | 1950.1 milligrams | Standard Error 495.07 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 16 | 1864.2 milligrams | Standard Error 458.32 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 4 | 1868.9 milligrams | Standard Error 396.26 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 8 | 1902.4 milligrams | Standard Error 425.3 |
| Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 4 | 2366.6 milligrams | Standard Error 529.63 |
| Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 8 | 2269.4 milligrams | Standard Error 523.1 |
| Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 24 | 1828.8 milligrams | Standard Error 491.51 |
| Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 12 | 1992.3 milligrams | Standard Error 509.28 |
| Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 2 | 2703.4 milligrams | Standard Error 516.83 |
| Tanezumab 5 mg | Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 16 | 1897.6 milligrams | Standard Error 466.14 |
Comparison: Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.044195% CI: [0.39, 0.99]Negative binomial model
Comparison: Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.189595% CI: [0.46, 1.17]Negative binomial model
Comparison: Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.056795% CI: [0.35, 1.01]Negative binomial model
Comparison: Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.29695% CI: [0.44, 1.28]Negative binomial model
Comparison: Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.121595% CI: [0.37, 1.12]Negative binomial model
Comparison: Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.356995% CI: [0.44, 1.34]Negative binomial model
Comparison: Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.209695% CI: [0.36, 1.25]Negative binomial model
Comparison: Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.238795% CI: [0.37, 1.28]Negative binomial model
Comparison: Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.262795% CI: [0.39, 1.29]Negative binomial model
Comparison: Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment groupp-value: 0.286395% CI: [0.4, 1.31]Negative binomial model
Comparison: Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.55695% CI: [0.43, 1.58]Negative binomial model
Comparison: Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.507695% CI: [0.42, 1.53]Negative binomial model
Secondary
Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24
Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 8-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 12 | -1.84 units on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 6 | -1.48 units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 20 | -2.17 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint 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 Error 0.17 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 8 | -1.57 units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 1 | -0.57 units on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint 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 Error 0.15 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 2 | -0.98 units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 16 | -1.98 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 4 | -1.37 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 24 | -2.21 units on a scale | Standard Error 0.19 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 8 | -2.19 units on a scale | Standard Error 0.16 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 1 | -1.06 units on a scale | Standard Error 0.11 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 2 | -1.72 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 3 | -1.97 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 4 | -2.28 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 6 | -2.38 units on a scale | Standard Error 0.16 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 10 | -2.51 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 12 | -2.57 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 16 | -2.50 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 20 | -2.87 units on a scale | Standard Error 0.18 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 24 | -2.60 units on a scale | Standard Error 0.18 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 20 | -2.86 units on a scale | Standard Error 0.18 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 12 | -2.64 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 3 | -1.67 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 1 | -0.93 units on a scale | Standard Error 0.11 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 16 | -2.61 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 2 | -1.49 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 8 | -2.39 units on a scale | Standard Error 0.16 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 6 | -2.43 units on a scale | Standard Error 0.16 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 24 | -2.73 units on a scale | Standard Error 0.18 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 10 | -2.56 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 | Change at Week 4 | -2.13 units on a scale | Standard Error 0.15 |
Comparison: Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-0.7, -0.27]ANCOVA
Comparison: Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000995% CI: [-0.58, -0.15]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1, -0.48]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000195% CI: [-0.77, -0.25]ANCOVA
Comparison: Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.06, -0.5]ANCOVA
Comparison: Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000695% CI: [-0.77, -0.21]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.2, -0.62]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.06, -0.47]ANCOVA
Comparison: Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.2, -0.59]ANCOVA
Comparison: Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.25, -0.64]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000195% CI: [-0.93, -0.3]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.13, -0.5]ANCOVA
Comparison: Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.05, -0.39]ANCOVA
Comparison: Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.1, -0.44]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.06, -0.39]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.13, -0.46]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.00495% CI: [-0.87, -0.16]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000595% CI: [-0.98, -0.27]ANCOVA
Comparison: Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000295% CI: [-1.06, -0.33]ANCOVA
Comparison: Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.000295% CI: [-1.05, -0.32]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.050695% CI: [-0.78, 0]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.008695% CI: [-0.91, -0.13]ANCOVA
Secondary
Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32
Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 8-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Time frame: Baseline, Weeks 28 and 32
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32 | Change at Week 28 | -2.26 units on a scale | Standard Deviation 2.27 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32 | Baseline | 6.79 units on a scale | Standard Deviation 1.56 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32 | Change at Week 32 | -2.19 units on a scale | Standard Deviation 2.4 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32 | Change at Week 28 | -2.63 units on a scale | Standard Deviation 2.32 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32 | Baseline | 7.03 units on a scale | Standard Deviation 1.38 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32 | Change at Week 32 | -2.07 units on a scale | Standard Deviation 2.33 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32 | Baseline | 6.90 units on a scale | Standard Deviation 1.43 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32 | Change at Week 32 | -2.13 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32 | Change at Week 28 | -2.58 units on a scale | Standard Deviation 2.33 |
Secondary
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48
Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 12 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 11.38 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 2 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 10.26 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 4 | -0.3 millimeters of mercury (mmHg) | Standard Deviation 11.09 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 8 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 10.89 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP: Baseline | 132.0 millimeters of mercury (mmHg) | Standard Deviation 13.54 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 16 | -0.4 millimeters of mercury (mmHg) | Standard Deviation 12.18 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 24 | -1.5 millimeters of mercury (mmHg) | Standard Deviation 11.47 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 32 | -2.1 millimeters of mercury (mmHg) | Standard Deviation 12.61 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 48 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 10.38 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP: Baseline | 79.7 millimeters of mercury (mmHg) | Standard Deviation 8.28 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 2 | -0.4 millimeters of mercury (mmHg) | Standard Deviation 6.81 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 4 | -0.6 millimeters of mercury (mmHg) | Standard Deviation 7.06 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 8 | -0.1 millimeters of mercury (mmHg) | Standard Deviation 7.59 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 12 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 7.44 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 16 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 7.85 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 24 | -0.1 millimeters of mercury (mmHg) | Standard Deviation 7.81 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 32 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 8.52 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 48 | -0.6 millimeters of mercury (mmHg) | Standard Deviation 7.22 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 48 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 8.32 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP: Baseline | 132.7 millimeters of mercury (mmHg) | Standard Deviation 12.59 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP: Baseline | 79.3 millimeters of mercury (mmHg) | Standard Deviation 8.45 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 8 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 7.11 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 2 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 11.24 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 16 | -0.6 millimeters of mercury (mmHg) | Standard Deviation 8.26 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 24 | -0.2 millimeters of mercury (mmHg) | Standard Deviation 8.42 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 4 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 10.94 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 2 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 7.18 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 32 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 8.06 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 8 | -2.1 millimeters of mercury (mmHg) | Standard Deviation 10.63 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 48 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 11.6 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 12 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 7.79 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 12 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 11.53 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 32 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 12.4 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 4 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 7.35 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 16 | -1.6 millimeters of mercury (mmHg) | Standard Deviation 12.92 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 24 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 12.55 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 16 | -2.3 millimeters of mercury (mmHg) | Standard Deviation 11.63 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 24 | -2.5 millimeters of mercury (mmHg) | Standard Deviation 12.11 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 32 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 12.55 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 16 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 7.9 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 48 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 11.34 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 48 | -0.9 millimeters of mercury (mmHg) | Standard Deviation 8.17 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP: Baseline | 79.5 millimeters of mercury (mmHg) | Standard Deviation 8.1 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 2 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 7.33 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 24 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 7.9 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 4 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 7.85 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP: Baseline | 132.0 millimeters of mercury (mmHg) | Standard Deviation 12.12 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 2 | -2.4 millimeters of mercury (mmHg) | Standard Deviation 11.24 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 8 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 7.65 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 4 | -2.4 millimeters of mercury (mmHg) | Standard Deviation 11.52 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 8 | -2.5 millimeters of mercury (mmHg) | Standard Deviation 12.07 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | SBP:Change at Week 12 | -2.8 millimeters of mercury (mmHg) | Standard Deviation 11.64 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 12 | -2.8 millimeters of mercury (mmHg) | Standard Deviation 7.94 |
| Tanezumab 5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | DBP:Change at Week 32 | -1.5 millimeters of mercury (mmHg) | Standard Deviation 8.64 |
Secondary
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48
A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, QTcF, RR intervals) were collected.
Time frame: Baseline, Weeks 24 and 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | PR Interval:Change at Week 24 | 0.1 millisecond | Standard Deviation 14.07 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | RR Interval:Change at Week 24 | -3.2 millisecond | Standard Deviation 108.3 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | RR Interval:Change at Week 48 | -19.0 millisecond | Standard Deviation 118.49 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | PR Interval: Baseline | 168.7 millisecond | Standard Deviation 23.95 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | RR Interval: Baseline | 923.9 millisecond | Standard Deviation 124.86 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | PR Interval:Change at Week 48 | 1.3 millisecond | Standard Deviation 13.64 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QRS Interval: Baseline | 95.7 millisecond | Standard Deviation 12.69 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QRS Interval:Change at Week 24 | -0.2 millisecond | Standard Deviation 7.22 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QRS Interval:Change at Week 48 | -0.2 millisecond | Standard Deviation 8.04 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QT Interval: Baseline | 402.0 millisecond | Standard Deviation 28.45 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QT Interval:Change at Week 24 | -2.2 millisecond | Standard Deviation 22.65 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QT Interval:Change at Week 48 | -2.5 millisecond | Standard Deviation 23.27 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCB Interval: Baseline | 419.8 millisecond | Standard Deviation 22.32 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCB Interval:Change at Week 24 | -1.5 millisecond | Standard Deviation 17.56 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCB Interval:Change at Week 48 | 1.5 millisecond | Standard Deviation 16.45 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCF Interval: Baseline | 413.6 millisecond | Standard Deviation 20.7 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCF Interval:Change at Week 24 | -1.7 millisecond | Standard Deviation 15.72 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCF Interval:Change at Week 48 | 0.2 millisecond | Standard Deviation 14.5 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCF Interval:Change at Week 48 | 0.5 millisecond | Standard Deviation 15.58 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | RR Interval: Baseline | 923.6 millisecond | Standard Deviation 139.69 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QT Interval: Baseline | 403.1 millisecond | Standard Deviation 29.92 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCB Interval: Baseline | 421.3 millisecond | Standard Deviation 20.78 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | RR Interval:Change at Week 24 | -14.6 millisecond | Standard Deviation 119.62 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCB Interval:Change at Week 48 | 1.7 millisecond | Standard Deviation 16.7 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCF Interval: Baseline | 414.9 millisecond | Standard Deviation 19.23 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | RR Interval:Change at Week 48 | -16.0 millisecond | Standard Deviation 112.48 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QT Interval:Change at Week 24 | -3.1 millisecond | Standard Deviation 21.78 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCF Interval:Change at Week 24 | -1.0 millisecond | Standard Deviation 14.94 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | PR Interval: Baseline | 165.6 millisecond | Standard Deviation 21.92 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QRS Interval:Change at Week 48 | 0.2 millisecond | Standard Deviation 8.33 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCB Interval:Change at Week 24 | 0.2 millisecond | Standard Deviation 18.47 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | PR Interval:Change at Week 24 | 0.5 millisecond | Standard Deviation 13.38 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QRS Interval:Change at Week 24 | 0.2 millisecond | Standard Deviation 7.57 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QT Interval:Change at Week 48 | -1.6 millisecond | Standard Deviation 24.4 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | PR Interval:Change at Week 48 | -1.1 millisecond | Standard Deviation 14.38 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QRS Interval: Baseline | 95.6 millisecond | Standard Deviation 14.05 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | PR Interval:Change at Week 48 | -0.4 millisecond | Standard Deviation 14.23 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QRS Interval: Baseline | 95.8 millisecond | Standard Deviation 14.48 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QRS Interval:Change at Week 24 | 0.0 millisecond | Standard Deviation 7.34 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCB Interval:Change at Week 48 | 1.8 millisecond | Standard Deviation 16.8 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QRS Interval:Change at Week 48 | 0.8 millisecond | Standard Deviation 8.73 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCF Interval:Change at Week 48 | -0.5 millisecond | Standard Deviation 13.96 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QT Interval: Baseline | 405.6 millisecond | Standard Deviation 26.84 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QT Interval:Change at Week 24 | -3.8 millisecond | Standard Deviation 25.84 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCF Interval: Baseline | 416.6 millisecond | Standard Deviation 18.61 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QT Interval:Change at Week 48 | -4.9 millisecond | Standard Deviation 24.06 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | RR Interval: Baseline | 928.3 millisecond | Standard Deviation 126.14 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | RR Interval:Change at Week 24 | -16.1 millisecond | Standard Deviation 124.65 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCB Interval: Baseline | 422.5 millisecond | Standard Deviation 20.57 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | RR Interval:Change at Week 48 | -26.7 millisecond | Standard Deviation 125.81 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | PR Interval: Baseline | 168.0 millisecond | Standard Deviation 24.54 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | PR Interval:Change at Week 24 | 2.0 millisecond | Standard Deviation 15.43 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCB Interval:Change at Week 24 | 0.0 millisecond | Standard Deviation 16.26 |
| Tanezumab 5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48 | QTCF Interval:Change at Week 24 | -1.3 millisecond | Standard Deviation 15.05 |
Secondary
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48
Heart rate was measured at sitting position.
Time frame: Baseline, Weeks 24 and 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48 | change at Week 24 | 0.3 beats per minute | Standard Deviation 8.05 |
| Placebo | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48 | Baseline | 66.2 beats per minute | Standard Deviation 9.28 |
| Placebo | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48 | Change at Week 48 | 1.4 beats per minute | Standard Deviation 8.59 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48 | change at Week 24 | 0.9 beats per minute | Standard Deviation 9.15 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48 | Baseline | 66.5 beats per minute | Standard Deviation 10.69 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48 | Change at Week 48 | 1.1 beats per minute | Standard Deviation 8.98 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48 | Baseline | 65.9 beats per minute | Standard Deviation 9.22 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48 | Change at Week 48 | 2.3 beats per minute | Standard Deviation 10.44 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48 | change at Week 24 | 1.4 beats per minute | Standard Deviation 10.19 |
Secondary
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48
Heart rate was measured at sitting position.
Time frame: Baseline, Weeks 2, 4, 8, 12,16, 24, 32 and 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 8 | 0.5 beats per minute | Standard Deviation 7.61 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 48 | -0.2 beats per minute | Standard Deviation 8.13 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 16 | -0.3 beats per minute | Standard Deviation 8.13 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 12 | 0.9 beats per minute | Standard Deviation 8.14 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Baseline | 71.1 beats per minute | Standard Deviation 8.45 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 32 | 1.1 beats per minute | Standard Deviation 8.51 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 4 | 0.8 beats per minute | Standard Deviation 7.92 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 2 | 0.2 beats per minute | Standard Deviation 7.26 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 24 | -0.5 beats per minute | Standard Deviation 8.56 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 12 | 1.6 beats per minute | Standard Deviation 8.28 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Baseline | 70.4 beats per minute | Standard Deviation 8.62 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 2 | 1.2 beats per minute | Standard Deviation 7.25 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 4 | 0.9 beats per minute | Standard Deviation 7.91 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 8 | -0.3 beats per minute | Standard Deviation 8.08 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 16 | -0.4 beats per minute | Standard Deviation 8.01 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 24 | 0.5 beats per minute | Standard Deviation 8.77 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 32 | 0.8 beats per minute | Standard Deviation 8.19 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 48 | 1.4 beats per minute | Standard Deviation 9.87 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 4 | -0.1 beats per minute | Standard Deviation 7.99 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Baseline | 70.8 beats per minute | Standard Deviation 8.33 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 24 | 0.4 beats per minute | Standard Deviation 8.86 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 2 | 0.2 beats per minute | Standard Deviation 8.45 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 48 | 0.6 beats per minute | Standard Deviation 10.01 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 12 | 0.5 beats per minute | Standard Deviation 8.39 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 8 | -0.9 beats per minute | Standard Deviation 7.54 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 32 | 0.6 beats per minute | Standard Deviation 9.4 |
| Tanezumab 5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 16 | -0.0 beats per minute | Standard Deviation 8.12 |
Secondary
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48
NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 2 | 0.03 units on a scale | Standard Deviation 0.92 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 32 | -0.23 units on a scale | Standard Deviation 1.69 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 16 | -0.17 units on a scale | Standard Deviation 1.59 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Baseline | 1.35 units on a scale | Standard Deviation 2.85 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 24 | -0.20 units on a scale | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 8 | -0.11 units on a scale | Standard Deviation 1.42 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 4 | 0.01 units on a scale | Standard Deviation 1.16 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 48 | -0.22 units on a scale | Standard Deviation 1.67 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 12 | -0.12 units on a scale | Standard Deviation 1.38 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 2 | -0.09 units on a scale | Standard Deviation 0.68 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 4 | 0.00 units on a scale | Standard Deviation 1.31 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 8 | -0.13 units on a scale | Standard Deviation 1.2 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 12 | -0.03 units on a scale | Standard Deviation 1.5 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 16 | -0.03 units on a scale | Standard Deviation 1.72 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 24 | -0.01 units on a scale | Standard Deviation 1.85 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 32 | 0.00 units on a scale | Standard Deviation 1.75 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 48 | 0.01 units on a scale | Standard Deviation 1.91 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Baseline | 1.35 units on a scale | Standard Deviation 3.72 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 2 | -0.21 units on a scale | Standard Deviation 1.14 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 32 | -0.41 units on a scale | Standard Deviation 1.57 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 8 | -0.41 units on a scale | Standard Deviation 1.56 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Baseline | 1.48 units on a scale | Standard Deviation 3.11 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 48 | -0.43 units on a scale | Standard Deviation 1.57 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 16 | -0.46 units on a scale | Standard Deviation 1.53 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 4 | -0.32 units on a scale | Standard Deviation 1.24 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 24 | -0.47 units on a scale | Standard Deviation 1.58 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48 | Change at Week 12 | -0.39 units on a scale | Standard Deviation 1.59 |
Secondary
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32
PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worse condition.
Time frame: Baseline, Week 32
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32 | Baseline | 3.55 units on a scale | Standard Deviation 0.62 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32 | Change at Week 32 | -0.84 units on a scale | Standard Deviation 0.87 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32 | Baseline | 3.61 units on a scale | Standard Deviation 0.62 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32 | Change at Week 32 | -0.64 units on a scale | Standard Deviation 0.88 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32 | Baseline | 3.56 units on a scale | Standard Deviation 0.63 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32 | Change at Week 32 | -0.63 units on a scale | Standard Deviation 0.91 |
Secondary
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16
PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom 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 and inability to carry out all normal activities).
Time frame: Baseline, Weeks 2, 4, 8, 12 and 16
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -0.50 units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -0.64 units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -0.62 units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -0.71 units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -0.60 units on a scale | Standard Error 0.05 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -0.78 units on a scale | Standard Error 0.06 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -0.79 units on a scale | Standard Error 0.05 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -0.99 units on a scale | Standard Error 0.06 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -0.73 units on a scale | Standard Error 0.05 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -0.85 units on a scale | Standard Error 0.05 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -0.93 units on a scale | Standard Error 0.05 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -0.67 units on a scale | Standard Error 0.05 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -0.88 units on a scale | Standard Error 0.05 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -0.90 units on a scale | Standard Error 0.06 |
| Tanezumab 5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -1.03 units on a scale | Standard Error 0.06 |
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.33, -0.12]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.002295% CI: [-0.27, -0.06]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.35, -0.14]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.43, -0.22]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.002995% CI: [-0.28, -0.06]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.37, -0.15]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.4, -0.17]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.43, -0.2]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.035295% CI: [-0.26, -0.01]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.37, -0.13]ANCOVA
Secondary
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24
The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.
Time frame: Baseline, Week 24
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Number of symptoms reported: Baseline | 0.55 units on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Number of symptoms reported: Change at Week 24 | 0.03 units on a scale | Standard Deviation 1.07 |
| Placebo | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Total Symptom Impact Score: Baseline | 1.14 units on a scale | Standard Deviation 1.94 |
| Placebo | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Total Symptom Impact Score: Change at Week 24 | 0.32 units on a scale | Standard Deviation 2.92 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Total Symptom Impact Score: Change at Week 24 | 0.53 units on a scale | Standard Deviation 3.23 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Number of symptoms reported: Baseline | 0.53 units on a scale | Standard Deviation 0.85 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Total Symptom Impact Score: Baseline | 1.11 units on a scale | Standard Deviation 1.79 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Number of symptoms reported: Change at Week 24 | 0.15 units on a scale | Standard Deviation 1.18 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Total Symptom Impact Score: Change at Week 24 | 0.56 units on a scale | Standard Deviation 3.11 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Number of symptoms reported: Change at Week 24 | 0.18 units on a scale | Standard Deviation 1.22 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Total Symptom Impact Score: Baseline | 1.20 units on a scale | Standard Deviation 1.99 |
| Tanezumab 5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24 | Number of symptoms reported: Baseline | 0.55 units on a scale | Standard Deviation 0.83 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Time frame: Baseline, Week 32
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32 | Baseline | 6.57 units on a scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32 | Change at Week 32 | -2.61 units on a scale | Standard Deviation 1.96 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32 | Baseline | 6.63 units on a scale | Standard Deviation 0.96 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32 | Change at Week 32 | -2.28 units on a scale | Standard Deviation 1.87 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32 | Baseline | 6.60 units on a scale | Standard Deviation 0.91 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32 | Change at Week 32 | -2.27 units on a scale | Standard Deviation 2.12 |
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: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | -1.28 units on a scale | Standard Error 0.13 |
| Placebo | 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 | -1.80 units on a scale | Standard Error 0.14 |
| Placebo | 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 | -1.81 units on a scale | Standard Error 0.15 |
| Placebo | 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 | -2.11 units on a scale | Standard Error 0.16 |
| Placebo | 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 | -2.04 units on a scale | Standard Error 0.17 |
| Placebo | 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 | -2.11 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | 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 | -2.66 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | 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 | -1.99 units on a scale | Standard Error 0.13 |
| Tanezumab 2.5 mg | 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 | -2.89 units on a scale | Standard Error 0.16 |
| Tanezumab 2.5 mg | 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 | -2.67 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | 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 | -2.57 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | 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 | -2.42 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | 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 | -2.60 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | 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 | -2.65 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | 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 | -2.83 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | 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 | -2.92 units on a scale | Standard Error 0.16 |
| Tanezumab 5 mg | 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 | -1.75 units on a scale | Standard Error 0.13 |
| Tanezumab 5 mg | 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 | -2.71 units on a scale | Standard Error 0.16 |
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.96, -0.45]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000495% CI: [-0.73, -0.21]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.04, -0.49]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.08, -0.53]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.9, -0.32]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.13, -0.56]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.09, -0.47]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.12, -0.5]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000195% CI: [-0.95, -0.35]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.99, -0.35]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.001595% CI: [-0.89, -0.21]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.07, -0.39]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Week 32
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32 | Baseline | 6.59 units on a scale | Standard Deviation 0.94 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32 | Change at Week 32 | -2.70 units on a scale | Standard Deviation 2.06 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32 | Baseline | 6.70 units on a scale | Standard Deviation 0.94 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32 | Change at Week 32 | -2.29 units on a scale | Standard Deviation 1.95 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32 | Baseline | 6.60 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32 | Change at Week 32 | -2.26 units on a scale | Standard Deviation 2.24 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 12 and 16
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -2.19 units on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -1.84 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -1.35 units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -1.78 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -2.10 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -2.47 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -2.02 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -2.57 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -2.91 units on a scale | Standard Error 0.16 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -2.69 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -2.69 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -2.96 units on a scale | Standard Error 0.16 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -1.69 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -2.61 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -2.56 units on a scale | Standard Error 0.15 |
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.94, -0.4]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.014995% CI: [-0.61, -0.07]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.08, -0.5]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.07, -0.5]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.92, -0.32]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.07, -0.47]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.05, -0.39]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.09, -0.44]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000595% CI: [-0.93, -0.26]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000495% CI: [-0.93, -0.27]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Week 32
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32 | Baseline | 7.65 units on a scale | Standard Deviation 1.13 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32 | Change at Week 32 | -2.72 units on a scale | Standard Deviation 2.32 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32 | Baseline | 7.79 units on a scale | Standard Deviation 1.06 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32 | Change at Week 32 | -2.23 units on a scale | Standard Deviation 2.09 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32 | Baseline | 7.66 units on a scale | Standard Deviation 1.18 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32 | Change at Week 32 | -2.15 units on a scale | Standard Deviation 2.41 |
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
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | -1.39 units on a scale | Standard Error 0.15 |
| Placebo | 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 | -1.76 units on a scale | Standard Error 0.16 |
| Placebo | 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 | -1.72 units on a scale | Standard Error 0.17 |
| Placebo | 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 | -2.17 units on a scale | Standard Error 0.18 |
| Placebo | 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 | -2.06 units on a scale | Standard Error 0.18 |
| Placebo | 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 | -2.32 units on a scale | Standard Error 0.19 |
| Tanezumab 2.5 mg | 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 | -2.76 units on a scale | Standard Error 0.18 |
| Tanezumab 2.5 mg | 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 | -2.08 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5 mg | 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 | -2.92 units on a scale | Standard Error 0.18 |
| Tanezumab 2.5 mg | 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 | -2.72 units on a scale | Standard Error 0.18 |
| Tanezumab 2.5 mg | 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 | -2.73 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5 mg | 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 | -2.49 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | 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 | -2.72 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | 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 | -2.74 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | 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 | -3.04 units on a scale | Standard Error 0.18 |
| Tanezumab 5 mg | 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 | -3.05 units on a scale | Standard Error 0.18 |
| Tanezumab 5 mg | 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 | -1.96 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | 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 | -2.83 units on a scale | Standard Error 0.18 |
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.99, -0.39]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000295% CI: [-0.87, -0.27]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.29, -0.65]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.28, -0.65]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.11, -0.42]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.35, -0.67]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.11, -0.39]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.23, -0.51]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000595% CI: [-1.03, -0.29]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.13, -0.4]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.024695% CI: [-0.82, -0.06]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000395% CI: [-1.1, -0.33]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 32
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Week 32
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 32 | Baseline | 6.73 units on a scale | Standard Deviation 1.25 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 32 | Change at Week 32 | -2.46 units on a scale | Standard Deviation 2.24 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 32 | Baseline | 6.77 units on a scale | Standard Deviation 1.27 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 32 | Change at Week 32 | -2.01 units on a scale | Standard Deviation 2.1 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 32 | Baseline | 6.79 units on a scale | Standard Deviation 1.19 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 32 | Change at Week 32 | -1.99 units on a scale | Standard Deviation 2.49 |
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
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | -1.27 units on a scale | Standard Error 0.14 |
| Placebo | 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 | -1.69 units on a scale | Standard Error 0.15 |
| Placebo | 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 | -1.77 units on a scale | Standard Error 0.16 |
| Placebo | 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 | -2.17 units on a scale | Standard Error 0.17 |
| Placebo | 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 | -2.06 units on a scale | Standard Error 0.18 |
| Placebo | 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 | -2.21 units on a scale | Standard Error 0.18 |
| Tanezumab 2.5 mg | 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 | -2.61 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | 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 | -1.94 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | 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 | -2.91 units on a scale | Standard Error 0.16 |
| Tanezumab 2.5 mg | 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 | -2.68 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | 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 | -2.51 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5 mg | 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 | -2.36 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | 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 | -2.54 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | 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 | -2.49 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | 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 | -2.80 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | 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 | -2.97 units on a scale | Standard Error 0.16 |
| Tanezumab 5 mg | 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 | -1.64 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | 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 | -2.66 units on a scale | Standard Error 0.17 |
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.96, -0.38]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.013995% CI: [-0.67, -0.08]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.13, -0.51]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.16, -0.55]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000395% CI: [-0.91, -0.27]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.04, -0.4]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.08, -0.39]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.14, -0.44]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000695% CI: [-0.98, -0.27]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000995% CI: [-0.96, -0.25]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.037795% CI: [-0.78, -0.02]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.001995% CI: [-0.96, -0.22]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Time frame: Baseline, Week 32
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32 | Baseline | 6.59 units on a scale | Standard Deviation 0.94 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32 | Change at Week 32 | -2.70 units on a scale | Standard Deviation 2.06 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32 | Baseline | 6.70 units on a scale | Standard Deviation 0.94 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32 | Change at Week 32 | -2.29 units on a scale | Standard Deviation 1.95 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32 | Baseline | 6.60 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32 | Change at Week 32 | -2.26 units on a scale | Standard Deviation 2.24 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Time frame: Baseline, Weeks 2, 4, 8, 12 and 16
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -2.04 units on a scale | Standard Error 2.16 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -1.76 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -1.26 units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -1.71 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -2.02 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -2.38 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -1.95 units on a scale | Standard Error 0.14 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -2.52 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -2.83 units on a scale | Standard Error 0.16 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -2.68 units on a scale | Standard Error 0.16 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -2.69 units on a scale | Standard Error 0.16 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -2.87 units on a scale | Standard Error 0.16 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -1.69 units on a scale | Standard Error 0.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -2.52 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -2.50 units on a scale | Standard Error 0.15 |
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.95, -0.42]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.001495% CI: [-0.7, -0.17]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.09, -0.53]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.08, -0.51]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.93, -0.33]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.06, -0.47]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.11, -0.46]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.15, -0.5]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1, -0.34]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1, -0.35]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on a NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Time frame: Baseline, Week 32
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32 | Baseline | 6.46 units on a scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32 | Change at Week 32 | -2.57 units on a scale | Standard Deviation 2.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32 | Baseline | 6.44 units on a scale | Standard Deviation 1.59 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32 | Change at Week 32 | -2.34 units on a scale | Standard Deviation 2.18 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32 | Baseline | 6.44 units on a scale | Standard Deviation 1.53 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32 | Change at Week 32 | -2.31 units on a scale | Standard Deviation 2.51 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale 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. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 2 | -1.25 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 4 | -1.90 units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 8 | -1.82 units on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 12 | -2.10 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 16 | -2.00 units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 24 | -1.97 units on a scale | Standard Error 0.19 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 24 | -2.59 units on a scale | Standard Error 0.19 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 2 | -2.03 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 12 | -2.90 units on a scale | Standard Error 0.17 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 16 | -2.65 units on a scale | Standard Error 0.18 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 4 | -2.62 units on a scale | Standard Error 0.16 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 8 | -2.41 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 4 | -2.74 units on a scale | Standard Error 0.16 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 8 | -2.81 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 24 | -2.84 units on a scale | Standard Error 0.19 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 12 | -2.95 units on a scale | Standard Error 0.17 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 2 | -1.90 units on a scale | Standard Error 0.15 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24 | Change at Week 16 | -2.77 units on a scale | Standard Error 0.18 |
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.07, -0.48]ANCOVA
Comparison: Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-0.94, -0.35]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.03, -0.41]ANCOVA
Comparison: Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.15, -0.53]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000495% CI: [-0.91, -0.26]ANCOVA
Comparison: Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.31, -0.67]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.14, -0.46]ANCOVA
Comparison: Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.18, -0.5]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000295% CI: [-1, -0.3]ANCOVA
Comparison: Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.12, -0.43]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.p-value: 0.001395% CI: [-0.99, -0.24]ANCOVA
Comparison: Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.25, -0.5]ANCOVA
Secondary
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24
WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Time frame: Baseline, Weeks 8, 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8: Percent Work Time Missed | 0.04 units on a scale | Standard Error 2.12 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8:Percent Impairment While Working | -13.57 units on a scale | Standard Error 3.11 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8: Percent Overall Work Impairment | -13.78 units on a scale | Standard Error 3.2 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8: Percent Activity Impairment | -15.66 units on a scale | Standard Error 1.55 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16: Percent Work Time Missed | 2.36 units on a scale | Standard Error 2.24 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16:Percent Impairment While Working | -15.92 units on a scale | Standard Error 3.28 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16: Percent Overall Work Impairment | -16.38 units on a scale | Standard Error 3.33 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16: Percent Activity Impairment | -19.15 units on a scale | Standard Error 1.77 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24: Percent Work Time Missed | 4.09 units on a scale | Standard Error 3.27 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24:Percent Impairment While Working | -15.03 units on a scale | Standard Error 3.86 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24: Percent Overall Work Impairment | -15.17 units on a scale | Standard Error 3.92 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24: Percent Activity Impairment | -21.49 units on a scale | Standard Error 1.84 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24: Percent Activity Impairment | -24.57 units on a scale | Standard Error 1.79 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8: Percent Work Time Missed | 1.24 units on a scale | Standard Error 2.12 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16: Percent Overall Work Impairment | -25.79 units on a scale | Standard Error 3.37 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24: Percent Work Time Missed | 2.77 units on a scale | Standard Error 3.18 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8:Percent Impairment While Working | -20.26 units on a scale | Standard Error 3.1 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16:Percent Impairment While Working | -26.23 units on a scale | Standard Error 3.33 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24: Percent Overall Work Impairment | -19.03 units on a scale | Standard Error 3.56 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8: Percent Overall Work Impairment | -20.53 units on a scale | Standard Error 3.18 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16: Percent Activity Impairment | -25.16 units on a scale | Standard Error 1.77 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16: Percent Work Time Missed | 1.74 units on a scale | Standard Error 2.29 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8: Percent Activity Impairment | -21.84 units on a scale | Standard Error 1.54 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24:Percent Impairment While Working | -19.31 units on a scale | Standard Error 3.5 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8: Percent Activity Impairment | -24.79 units on a scale | Standard Error 1.53 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16: Percent Work Time Missed | -2.16 units on a scale | Standard Error 2.36 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24:Percent Impairment While Working | -17.77 units on a scale | Standard Error 3.74 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16:Percent Impairment While Working | -26.48 units on a scale | Standard Error 3.42 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16: Percent Overall Work Impairment | -26.42 units on a scale | Standard Error 3.47 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 16: Percent Activity Impairment | -26.13 units on a scale | Standard Error 1.74 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24: Percent Overall Work Impairment | -17.29 units on a scale | Standard Error 3.82 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8: Percent Work Time Missed | -2.05 units on a scale | Standard Error 2.11 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8:Percent Impairment While Working | -26.26 units on a scale | Standard Error 3.12 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24: Percent Work Time Missed | 1.16 units on a scale | Standard Error 3.27 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 8: Percent Overall Work Impairment | -26.26 units on a scale | Standard Error 3.22 |
| Tanezumab 5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24 | Change at Week 24: Percent Activity Impairment | -26.44 units on a scale | Standard Error 1.79 |
Comparison: Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.642795% CI: [-3.9, 6.29]ANCOVA
Comparison: Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.420895% CI: [-7.22, 3.04]ANCOVA
Comparison: Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.820495% CI: [-6.03, 4.79]ANCOVA
Comparison: Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.115795% CI: [-10.16, 1.13]ANCOVA
Comparison: Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.584595% CI: [-6.12, 3.47]ANCOVA
Comparison: Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.251495% CI: [-7.97, 2.11]ANCOVA
Comparison: Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.071795% CI: [-13.97, 0.6]ANCOVA
Comparison: Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.00195% CI: [-20.11, -5.26]ANCOVA
Comparison: Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.007995% CI: [-17.85, -2.77]ANCOVA
Comparison: Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.009695% CI: [-18.49, -2.63]ANCOVA
Comparison: Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.330295% CI: [-12.97, 4.41]ANCOVA
Comparison: Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.548395% CI: [-11.78, 6.3]ANCOVA
Comparison: Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.077495% CI: [-14.26, 0.76]ANCOVA
Comparison: Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.001795% CI: [-20.15, -4.81]ANCOVA
Comparison: Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.013595% CI: [-16.83, -1.99]ANCOVA
Comparison: Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.012995% CI: [-17.91, -2.17]ANCOVA
Comparison: Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.386995% CI: [-12.66, 4.96]ANCOVA
Comparison: Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.648595% CI: [-11.31, 7.08]ANCOVA
Comparison: Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.000195% CI: [-9.34, -3.03]ANCOVA
Comparison: Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: <0.000195% CI: [-12.26, -6]ANCOVA
Comparison: Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.000895% CI: [-9.51, -2.5]ANCOVA
Comparison: Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: <0.000195% CI: [-10.44, -3.51]ANCOVA
Comparison: Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.p-value: 0.100495% CI: [-6.76, 0.6]ANCOVA
Comparison: Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effectp-value: 0.007995% CI: [-8.59, -1.3]ANCOVA
Secondary
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.
Time frame: Baseline, Weeks 8, 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.78 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Usual activities | 2.5 units on a scale | Standard Deviation 0.78 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Self-care | 2.4 units on a scale | Standard Deviation 0.92 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Pain/Discomfort | 2.5 units on a scale | Standard Deviation 0.82 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Pain/Discomfort | 2.7 units on a scale | Standard Deviation 0.85 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Pain/Discomfort | 3.3 units on a scale | Standard Deviation 0.72 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Usual activities | 2.3 units on a scale | Standard Deviation 0.81 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Anxiety/Depression | 1.5 units on a scale | Standard Deviation 0.8 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.67 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Self-care | 1.8 units on a scale | Standard Deviation 0.88 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Mobility | 2.4 units on a scale | Standard Deviation 0.88 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Usual activities | 2.3 units on a scale | Standard Deviation 0.78 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Anxiety/Depression | 1.7 units on a scale | Standard Deviation 0.87 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Pain/Discomfort | 2.5 units on a scale | Standard Deviation 0.81 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Self-care | 1.7 units on a scale | Standard Deviation 0.83 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Mobility | 2.6 units on a scale | Standard Deviation 0.82 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 3.0 units on a scale | Standard Deviation 0.65 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Mobility | 2.4 units on a scale | Standard Deviation 0.78 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Self-care | 2.0 units on a scale | Standard Deviation 0.9 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Mobility | 3.1 units on a scale | Standard Deviation 0.63 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Usual activities | 2.2 units on a scale | Standard Deviation 0.82 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Self-care | 2.3 units on a scale | Standard Deviation 0.92 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Mobility | 3.1 units on a scale | Standard Deviation 0.62 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 3.0 units on a scale | Standard Deviation 0.68 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Pain/Discomfort | 3.2 units on a scale | Standard Deviation 0.73 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Anxiety/Depression | 1.7 units on a scale | Standard Deviation 0.88 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Mobility | 2.3 units on a scale | Standard Deviation 0.83 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Self-care | 1.8 units on a scale | Standard Deviation 0.8 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Usual activities | 2.3 units on a scale | Standard Deviation 0.82 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Pain/Discomfort | 2.5 units on a scale | Standard Deviation 0.8 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.64 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Mobility | 2.2 units on a scale | Standard Deviation 0.84 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Self-care | 1.7 units on a scale | Standard Deviation 0.78 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Usual activities | 2.2 units on a scale | Standard Deviation 0.78 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Pain/Discomfort | 2.3 units on a scale | Standard Deviation 0.8 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Anxiety/Depression | 1.3 units on a scale | Standard Deviation 0.61 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Mobility | 2.3 units on a scale | Standard Deviation 0.84 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Self-care | 1.7 units on a scale | Standard Deviation 0.77 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Pain/Discomfort | 2.4 units on a scale | Standard Deviation 0.78 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.71 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Self-care | 2.3 units on a scale | Standard Deviation 0.9 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Pain/Discomfort | 2.3 units on a scale | Standard Deviation 0.8 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Self-care | 1.6 units on a scale | Standard Deviation 0.78 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.68 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.68 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Mobility | 2.3 units on a scale | Standard Deviation 0.8 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Pain/Discomfort | 2.4 units on a scale | Standard Deviation 0.77 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Mobility | 2.3 units on a scale | Standard Deviation 0.84 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Anxiety/Depression | 1.7 units on a scale | Standard Deviation 0.87 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Mobility | 3.2 units on a scale | Standard Deviation 0.65 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Self-care | 1.6 units on a scale | Standard Deviation 0.76 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Pain/Discomfort | 3.3 units on a scale | Standard Deviation 0.69 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Mobility | 2.2 units on a scale | Standard Deviation 0.84 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.71 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 3.0 units on a scale | Standard Deviation 0.68 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Self-care | 1.6 units on a scale | Standard Deviation 0.8 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Pain/Discomfort | 2.4 units on a scale | Standard Deviation 0.79 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 24: Usual activities | 2.2 units on a scale | Standard Deviation 0.82 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Usual activities | 2.1 units on a scale | Standard Deviation 0.84 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Usual activities | 2.2 units on a scale | Standard Deviation 0.78 |
Secondary
European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than equal to (\<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.
Time frame: Baseline, Weeks 8, 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Baseline | 0.57 units on a scale | Standard Deviation 0.18 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 8 | 0.67 units on a scale | Standard Deviation 0.17 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 16 | 0.70 units on a scale | Standard Deviation 0.19 |
| Placebo | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 24 | 0.70 units on a scale | Standard Deviation 0.16 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 24 | 0.72 units on a scale | Standard Deviation 0.16 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Baseline | 0.56 units on a scale | Standard Deviation 0.18 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 16 | 0.73 units on a scale | Standard Deviation 0.15 |
| Tanezumab 2.5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 8 | 0.71 units on a scale | Standard Deviation 0.16 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 24 | 0.73 units on a scale | Standard Deviation 0.15 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 8 | 0.73 units on a scale | Standard Deviation 0.17 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Week 16 | 0.73 units on a scale | Standard Deviation 0.17 |
| Tanezumab 5 mg | European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value | Baseline | 0.56 units on a scale | Standard Deviation 0.18 |
Secondary
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis
Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 32 and Week 48. Domain evaluated was duration since quitting job due to OA.
Time frame: Baseline, Weeks 32 and 48
Population: ITT population: all randomized participants who received at least one dose of SC study medication (either Tanezumab or placebo). One additional participant apart from the ones who had responded for quitting job responded to duration since quitting job. 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 48 | 0.8 years |
| Placebo | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 32 | 0.5 years |
| Placebo | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline | 2.0 years |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 48 | 2.5 years |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline | 1.0 years |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 32 | 2.4 years |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 48 | 0.7 years |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline | 5.3 years |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 32 | 1.1 years |
Secondary
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of nights stayed in the hospital due to OA.
Time frame: Baseline, Weeks 32 and 48
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Baseline | 1.0 nights |
| Placebo | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 32 | 5.0 nights |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 32 | 21.0 nights |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Baseline | 11.0 nights |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 48 | 1.0 nights |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 32 | 2.0 nights |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 48 | 1.0 nights |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Baseline | 1.0 nights |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of participants who were hospitalized due to OA.
Time frame: Baseline, Weeks 32 and 48
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 32 | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 48 | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 32 | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 48 | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 48 | 5 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 32 | 1 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis
Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 32 and Week 48. Domain evaluated was number of participants who quit job due to OA.
Time frame: Baseline, Weeks 32 and 48
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 32 | 7 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Baseline | 13 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 48 | 7 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 32 | 9 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Baseline | 12 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 48 | 7 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Baseline | 9 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 48 | 4 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 32 | 4 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.
Time frame: Baseline, Weeks 32 and 48
Population: The intent to treat (ITT) population included all randomized participants who received at least one dose of subcutaneous (SC) study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Never | 200 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Never | 225 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Always | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Rarely | 4 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Sometimes | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Often | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Sometimes | 8 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Always | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Sometimes | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Often | 4 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Sometimes | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Rarely | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Always | 9 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Never | 246 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Never | 248 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Sometimes | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Always | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Rarely | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Rarely | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Sometimes | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Always | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Sometimes | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Often | 7 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Rarely | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Always | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Never | 248 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Never | 217 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Never | 271 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Rarely | 4 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Always | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Rarely | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Rarely | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Sometimes | 4 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Always | 9 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Sometimes | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Often | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Never | 250 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Rarely | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Always | 3 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Never | 215 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Never | 217 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Never | 275 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Never | 281 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Always | 7 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Rarely | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Often | 4 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Sometimes | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Always | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Sometimes | 6 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Often | 3 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Rarely | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Rarely | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Always | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Sometimes | 11 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Sometimes | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Never | 240 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Rarely | 8 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Sometimes | 13 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Often | 12 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Always | 9 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Never | 282 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Sometimes | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Often | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Always | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Never | 274 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Rarely | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Sometimes | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Often | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Always | 4 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Never | 265 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Rarely | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Sometimes | 8 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Often | 5 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Always | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Never | 232 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Rarely | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Sometimes | 8 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Often | 7 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Always | 12 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Never | 260 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Sometimes | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Often | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Never | 257 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Sometimes | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Often | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Always | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Never | 252 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Sometimes | 4 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Often | 4 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Always | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Never | 211 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Rarely | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Sometimes | 12 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Often | 8 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Always | 7 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Never | 240 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Sometimes | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Often | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Always | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Never | 238 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Always | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Often | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Always | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Never | 234 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Sometimes | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Often | 3 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Always | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Always | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Sometimes | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Never | 191 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Often | 3 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Often | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Rarely | 3 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Sometimes | 4 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Never | 283 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Sometimes | 13 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Rarely | 5 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Rarely | 5 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Often | 10 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other aids or devices | Never | 270 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Always | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Walking aid use | Always | 14 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Always | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Always | 15 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Never | 230 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Often | 3 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Always | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Rarely | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Sometimes | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Never | 225 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Sometimes | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Rarely | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Often | 7 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Often | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Device/Utensil to dress bathe eat | Never | 279 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Often | 3 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Wheelchair use | Always | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Always | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Always | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Never | 246 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Often | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Other aids or devices | Rarely | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Rarely | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Sometimes | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Never | 228 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Sometimes | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Rarely | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Often | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Often | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Wheelchair use | Never | 250 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Sometimes | 15 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Device/Utensil to dress bathe eat | Always | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Always | 9 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Rarely | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Never | 245 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Often | 12 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Sometimes | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Rarely | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Sometimes | 10 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking aid use | Never | 242 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Sometimes | 3 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Rarely | 6 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 48: Device/Utensil to dress bathe eat | Sometimes | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Often | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Walking aid use | Never | 214 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline: Wheelchair use | Rarely | 0 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 32: Other aids or devices | Always | 1 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of participants who visited the emergency room due to osteoarthritis.
Time frame: Baseline, Weeks 32 and 48
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 32 | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Baseline | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 48 | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 32 | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Baseline | 3 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 48 | 1 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Baseline | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 48 | 2 Participants |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 32 | 0 Participants |
Secondary
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Visits of services directly related to osteoarthritis evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.
Time frame: Baseline, Weeks 32 and 48
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Other practitioner | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Chiropractor | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Home healthcare services | 10.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Primary Care Physician | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Pain specialist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Radiologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Neurologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Neurologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Nutritionist/dietitian | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Rheumatologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Physical therapist | 6.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Podiatrist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Physician assistant or nurse Practitioner | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Orthopedist | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Alternative medicine or therapy | 3.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Pain specialist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Primary Care Physician | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Physical therapist | 8.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Orthopedist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Orthopedist | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Physical therapist | 10.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Nutritionist/dietitian | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Pain specialist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Chiropractor | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Rheumatologist | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Physician assistant or nurse Practitioner | 5.5 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Alternative medicine or therapy | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Other practitioner | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Rheumatologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Podiatrist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Podiatrist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Neurologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Nutritionist/dietitian | 3.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Radiologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Physician assistant or nurse Practitioner | 3.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Primary Care Physician | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Home healthcare services | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Radiologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Other practitioner | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Podiatrist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Primary Care Physician | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Neurologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Rheumatologist | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Physician assistant or nurse Practitioner | 2.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Pain specialist | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Orthopedist | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Physical therapist | 3.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Chiropractor | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Alternative medicine or therapy | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Nutritionist/dietitian | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Radiologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Home healthcare services | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Other practitioner | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Primary Care Physician | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Neurologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Rheumatologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Physician assistant or nurse Practitioner | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Pain specialist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Orthopedist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Physical therapist | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Chiropractor | 8.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Alternative medicine or therapy | 2.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Podiatrist | 1.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Nutritionist/dietitian | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Radiologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Home healthcare services | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Other practitioner | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Primary Care Physician | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Neurologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Rheumatologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Physician assistant or nurse Practitioner | 2.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Pain specialist | 3.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Orthopedist | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Physical therapist | 6.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Chiropractor | 46.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Alternative medicine or therapy | 11.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Podiatrist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Nutritionist/dietitian | 130.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Radiologist | 1.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Home healthcare services | 5.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Other practitioner | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Nutritionist/dietitian | 3.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Other practitioner | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Radiologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Alternative medicine or therapy | 3.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Primary Care Physician | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Podiatrist | 3.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Rheumatologist | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Neurologist | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Alternative medicine or therapy | 2.5 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Radiologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Rheumatologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Chiropractor | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Podiatrist | 3.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Physician assistant or nurse Practitioner | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Physical therapist | 2.5 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Neurologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Pain specialist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Orthopedist | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Other practitioner | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Orthopedist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Pain specialist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Orthopedist | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Physical therapist | 5.5 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Pain specialist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Chiropractor | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Physician assistant or nurse Practitioner | 4.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Nutritionist/dietitian | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Alternative medicine or therapy | 1.5 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Rheumatologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Physical therapist | 10.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Podiatrist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Neurologist | 51.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Physician assistant or nurse Practitioner | 3.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Nutritionist/dietitian | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Primary Care Physician | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Primary Care Physician | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Radiologist | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Other practitioner | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 48: Chiropractor | 3.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 32: Home healthcare services | 10.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Home healthcare services | 24.0 visits |
Secondary
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis
Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of visits to the emergency room due to OA.
Time frame: Baseline, Weeks 32 and 48
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 32 | 1.5 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 48 | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 32 | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 48 | 2.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 48 | 1.0 visits |
| Tanezumab 5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline | 1.5 visits |
Secondary
Number of Days of Rescue Medication Used at Week 32
In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days per week the participants used the rescue medication during the 4 weeks up to and including the particular study week were summarized.
Time frame: Week 32
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Overall number of participants analyzed' signifies participants who took rescue medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Days of Rescue Medication Used at Week 32 | 1.8 days | Standard Deviation 2.24 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used at Week 32 | 2.2 days | Standard Deviation 2.34 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used at Week 32 | 2.0 days | Standard Deviation 2.28 |
Secondary
Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24
In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week a could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.
Time frame: Weeks 2, 4, 8, 12, 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 2 | 3.17 days | Standard Error 0.27 |
| Placebo | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 4 | 2.82 days | Standard Error 0.28 |
| Placebo | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 8 | 2.54 days | Standard Error 0.26 |
| Placebo | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 12 | 2.29 days | Standard Error 0.27 |
| Placebo | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 16 | 2.11 days | Standard Error 0.24 |
| Placebo | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 24 | 1.74 days | Standard Error 0.22 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 24 | 1.49 days | Standard Error 0.18 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 2 | 2.12 days | Standard Error 0.19 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 12 | 1.70 days | Standard Error 0.2 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 16 | 1.64 days | Standard Error 0.19 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 4 | 1.81 days | Standard Error 0.18 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 8 | 1.83 days | Standard Error 0.19 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 4 | 2.07 days | Standard Error 0.21 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 8 | 1.92 days | Standard Error 0.2 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 24 | 1.43 days | Standard Error 0.18 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 12 | 1.72 days | Standard Error 0.2 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 2 | 2.39 days | Standard Error 0.21 |
| Tanezumab 5 mg | Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24 | Week 16 | 1.70 days | Standard Error 0.19 |
Comparison: Week 2: Least square (LS) Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.000195% CI: [0.54, 0.82]Negative binomial model
Comparison: Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.006795% CI: [0.61, 0.92]Negative binomial model
Comparison: Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.000395% CI: [0.51, 0.82]Negative binomial model
Comparison: Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.011295% CI: [0.58, 0.93]Negative binomial model
Comparison: Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.009395% CI: [0.56, 0.92]Negative binomial model
Comparison: Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.023795% CI: [0.59, 0.96]Negative binomial model
Comparison: Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.037495% CI: [0.56, 0.98]Negative binomial model
Comparison: Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.046895% CI: [0.57, 1]Negative binomial model
Comparison: Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.075195% CI: [0.59, 1.03]Negative binomial model
Comparison: Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.130595% CI: [0.61, 1.06]Negative binomial model
Comparison: Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.305795% CI: [0.63, 1.16]Negative binomial model
Comparison: Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.p-value: 0.205695% CI: [0.61, 1.11]Negative binomial model
Secondary
Number of Participants Who Took Rescue Medication During Week 32
In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during the 4 weeks up to and including the particular study week were summarized.
Time frame: Week 32
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Took Rescue Medication During Week 32 | 130 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Week 32 | 158 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Week 32 | 149 Participants |
Secondary
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24
In case of inadequate pain relief, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication between day 1 and week 24. Number of participants with any use of rescue medication during the particular study week were summarized.
Time frame: Weeks 2, 4, 8, 12, 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 2 | 205 Participants |
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 4 | 181 Participants |
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 8 | 166 Participants |
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 12 | 151 Participants |
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 16 | 154 Participants |
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 24 | 126 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 24 | 127 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 2 | 150 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 12 | 122 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 16 | 130 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 4 | 134 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 8 | 135 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 4 | 150 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 8 | 146 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 24 | 115 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 12 | 122 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 2 | 169 Participants |
| Tanezumab 5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24 | Week 16 | 122 Participants |
Comparison: Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [0.29, 0.59]Regression, Logistic
Comparison: Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.00195% CI: [0.38, 0.78]Regression, Logistic
Comparison: Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [0.36, 0.7]Regression, Logistic
Comparison: Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.006795% CI: [0.44, 0.88]Regression, Logistic
Comparison: Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.008795% CI: [0.45, 0.89]Regression, Logistic
Comparison: Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.078795% CI: [0.53, 1.04]Regression, Logistic
Comparison: Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.012995% CI: [0.47, 0.91]Regression, Logistic
Comparison: Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.012495% CI: [0.47, 0.91]Regression, Logistic
Comparison: Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.039995% CI: [0.5, 0.98]Regression, Logistic
Comparison: Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.00695% CI: [0.45, 0.87]Regression, Logistic
Comparison: Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.944995% CI: [0.72, 1.42]Regression, Logistic
Comparison: Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.323895% CI: [0.6, 1.18]Regression, Logistic
Secondary
Number of Participants Who Withdrew Due to Lack of Efficacy
Number of participants who withdrew from treatment due to lack of efficacy have been reported here.
Time frame: Baseline up to Week 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Withdrew Due to Lack of Efficacy | 18 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 2 Participants |
| Tanezumab 5 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 3 Participants |
Comparison: Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.p-value: 0.002795% CI: [0.02, 0.46]Regression, Logistic
Comparison: Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.p-value: 0.003395% CI: [0.05, 0.54]Regression, Logistic
Secondary
Number of Participants With Anti Tanezumab Antibodies
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Participants listed as having anti-tanezumab antibodies had ADA titer level \>=3.32. Less than 3.32 was considered below the limit of quantitation.
Time frame: Baseline, Weeks 8,16, 24, 32 and 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Anti Tanezumab Antibodies | Week 24 | 19 Participants |
| Placebo | Number of Participants With Anti Tanezumab Antibodies | Baseline | 24 Participants |
| Placebo | Number of Participants With Anti Tanezumab Antibodies | Week 48 | 18 Participants |
| Placebo | Number of Participants With Anti Tanezumab Antibodies | Week 16 | 25 Participants |
| Placebo | Number of Participants With Anti Tanezumab Antibodies | Week 8 | 24 Participants |
| Placebo | Number of Participants With Anti Tanezumab Antibodies | Week 32 | 19 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 8 | 27 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 32 | 38 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 48 | 32 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 24 | 39 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 16 | 34 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti Tanezumab Antibodies | Baseline | 26 Participants |
| Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 48 | 31 Participants |
| Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 16 | 48 Participants |
| Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 24 | 49 Participants |
| Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Baseline | 36 Participants |
| Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 32 | 42 Participants |
| Tanezumab 5 mg | Number of Participants With Anti Tanezumab Antibodies | Week 8 | 41 Participants |
Secondary
Number of Participants With Confirmed Orthostatic Hypotension
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP \<=150 mmHg (mean supine): Reduction in systolic BP\>=20 mmHg or reduction in diastolic BP\>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP \>150 mmHg (mean supine): Reduction in systolic BP\>=30 mmHg or reduction in diastolic BP\>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, 'Overall number of participants analyzed' signifies participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 2 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 4 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 32 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 12 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 0 Participants |
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 2 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 32 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 4 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 12 | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 48 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Baseline | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 4 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 8 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 12 | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 16 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 24 | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 32 | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Confirmed Orthostatic Hypotension | Week 2 | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
Primary Abnormality criteria: hemoglobin; hematocrit; RBC count \< 0.8\*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*ULN; platelets \<0.5\*LLN,\>1.75\*upper limit of normal (ULN); white blood cell count\<0.6\*LLN, \>1.5\*ULN; Lymphocytes, Leukocytes, Neutrophils \<0.8\*LLN, \>1.2\*ULN; Basophils, Eosinophils, Monocytes \>1.2\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides \>1.3\*ULN; Urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN; Nitrite \>=1.
Time frame: Baseline up to Week 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here Overall number of participants analysed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 19 Participants |
| Tanezumab 2.5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 26 Participants |
| Tanezumab 5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 22 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
Primary Abnormality criteria: HGB, hematocrit, RBC count \<0.8\* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width \<0.9\*LLN, \>1.1\*upper limit of normal(ULN); platelets \<0.5\*LLN,\>1.75\*ULN; WBC count\<0.6\*LLN, \>1.5\*ULN; Lymphocytes,Leukocytes,Neutrophils \<0.8\*LLN, \>1.2\*ULN; Basophils,Eosinophils,Monocytes\>1.2\*ULN; Prothrombin time/Intl. normalized ratio\>1.1\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides \>1.3\*ULN; Urate\>1.2\*ULN; sodium\<0.95\*LLN,\>1.05\*ULN; potassium,chloride,calcium,magnesium,bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate\<0.8\*LLN, \>1.2\*ULN; glucose\<0.6\*LLN, \>1.5\*ULN; HGB A1C \>1.3\*ULN; creatine kinase\>2.0\*ULN, specific gravity\<1.003, \>1.030; pH\<4.5, \>8; Urine Glucose, protein,HGB,bilirubin \>=1; Ketones\>=1;Urine erythrocytes,Leukocytes\>=20.
Time frame: Baseline up to Week 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 32 Participants |
| Tanezumab 2.5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 34 Participants |
| Tanezumab 5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 34 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to week 48 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
Time frame: Baseline up to Week 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | AEs | 178 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | SAEs | 11 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | AEs | 184 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | SAEs | 24 Participants |
| Tanezumab 5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | AEs | 198 Participants |
| Tanezumab 5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | SAEs | 27 Participants |
Secondary
Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to week 48 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Time frame: Baseline up to Week 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | AEs | 46 Participants |
| Placebo | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | SAEs | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | AEs | 52 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | SAEs | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | AEs | 59 Participants |
| Tanezumab 5 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study | SAEs | 3 Participants |
Secondary
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using interactive response technology (IRT) on a 5 point likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product.
Time frame: Weeks 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | Yes, definitely prefer the study drug | 106 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | Slight preference for the study drug | 66 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | No preference either way | 65 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | Slight preference for my previous treatment | 14 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | No, definitely prefer my previous treatment | 17 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | Yes, definitely prefer the study drug | 87 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | Slight preference for the study drug | 73 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | No preference either way | 58 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | Slight preference for my previous treatment | 14 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | No, definitely prefer my previous treatment | 6 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | Slight preference for my previous treatment | 4 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | Yes, definitely prefer the study drug | 129 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | Yes, definitely prefer the study drug | 129 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | No, definitely prefer my previous treatment | 3 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | Slight preference for the study drug | 86 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | No, definitely prefer my previous treatment | 2 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | No preference either way | 43 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | No preference either way | 41 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | Slight preference for the study drug | 79 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | Slight preference for my previous treatment | 11 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | No preference either way | 36 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | Slight preference for my previous treatment | 4 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | No, definitely prefer my previous treatment | 5 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | Yes, definitely prefer the study drug | 127 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | Slight preference for my previous treatment | 8 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | Slight preference for the study drug | 78 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | Yes, definitely prefer the study drug | 138 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 24 | No, definitely prefer my previous treatment | 6 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | Slight preference for the study drug | 83 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? | Week 16 | No preference either way | 48 Participants |
Secondary
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling?
The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess previous treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment.
Time frame: Weeks 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Injectable prescription medicines | 23 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines taken by mouth | 214 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Surgery | 5 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines and surgery | 8 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | No treatment | 18 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Injectable prescription medicines | 16 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Prescription medicines taken by mouth | 196 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Surgery | 3 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Prescription medicines and surgery | 4 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | No treatment | 19 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Prescription medicines and surgery | 3 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Injectable prescription medicines | 34 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Injectable prescription medicines | 21 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | No treatment | 19 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines taken by mouth | 212 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | No treatment | 22 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Surgery | 0 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Surgery | 0 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Prescription medicines taken by mouth | 211 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines and surgery | 5 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Surgery | 3 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines and surgery | 5 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | No treatment | 20 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Injectable prescription medicines | 35 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Prescription medicines and surgery | 4 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | Prescription medicines taken by mouth | 196 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Injectable prescription medicines | 28 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 24 | No treatment | 17 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Prescription medicines taken by mouth | 224 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling? | Week 16 | Surgery | 1 Participants |
Secondary
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study?
The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. For participant satisfaction, participants responded using interactive response technology (IRT) on a 5 point likert scale from 1-5, where 1=extremely dissatisfied, 2=dissatisfied, 3=neither satisfied nor dissatisfied, 4=satisfied and 5=extremely satisfied. Higher scores indicated greater satisfaction.
Time frame: Weeks 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Extremely Satisfied | 41 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Satisfied | 109 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Neither satisfied nor dissatisfied | 78 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Dissatisfied | 31 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Extremely dissatisfied | 9 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Extremely Satisfied | 46 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Satisfied | 97 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Neither satisfied nor dissatisfied | 64 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Dissatisfied | 28 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Extremely dissatisfied | 3 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Dissatisfied | 10 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Extremely Satisfied | 65 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Extremely Satisfied | 72 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Extremely dissatisfied | 1 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Satisfied | 141 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Extremely dissatisfied | 2 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Neither satisfied nor dissatisfied | 54 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Neither satisfied nor dissatisfied | 50 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Satisfied | 119 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Dissatisfied | 13 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Neither satisfied nor dissatisfied | 48 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Dissatisfied | 11 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Extremely dissatisfied | 2 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Extremely Satisfied | 66 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Dissatisfied | 9 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Satisfied | 128 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Extremely Satisfied | 65 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 24 | Extremely dissatisfied | 4 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Satisfied | 137 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study? | Week 16 | Neither satisfied nor dissatisfied | 63 Participants |
Secondary
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain?
The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess Patient willingness to use drug again, participants responded using interactive response technology (IRT) on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product.
Time frame: Weeks 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | Yes, definitely want to use the same drug again | 111 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | Might want to use the same drug again | 67 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | I am not sure | 59 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | Might not want to use the same drug again | 10 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | No:definitely wouldn't want to use same drug again | 21 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | Yes, definitely want to use the same drug again | 101 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | Might want to use the same drug again | 62 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | I am not sure | 53 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | Might not want to use the same drug again | 13 Participants |
| Placebo | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | No:definitely wouldn't want to use same drug again | 9 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | Might not want to use the same drug again | 5 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | Yes, definitely want to use the same drug again | 144 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | Yes, definitely want to use the same drug again | 131 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | No:definitely wouldn't want to use same drug again | 5 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | Might want to use the same drug again | 83 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | No:definitely wouldn't want to use same drug again | 5 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | I am not sure | 43 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | I am not sure | 29 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | Might want to use the same drug again | 73 Participants |
| Tanezumab 2.5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | Might not want to use the same drug again | 9 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | I am not sure | 38 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | Might not want to use the same drug again | 5 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | No:definitely wouldn't want to use same drug again | 3 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | Yes, definitely want to use the same drug again | 139 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | Might not want to use the same drug again | 9 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | Might want to use the same drug again | 63 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | Yes, definitely want to use the same drug again | 155 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 24 | No:definitely wouldn't want to use same drug again | 6 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | Might want to use the same drug again | 74 Participants |
| Tanezumab 5 mg | Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain? | Week 16 | I am not sure | 41 Participants |
Secondary
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from Baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Weeks 2, 4, 8, 12, 16, 24 and 32
Population: ITT population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure and 'Number analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 8.5 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 14.6 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 14.6 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 2 | 8.5 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 32 | 19.9 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 24 | 17.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 8 | 12.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 26.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 2 | 15.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 17.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 8 | 21.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 22.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 24 | 24.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 32 | 14.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 27.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 19.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 32 | 15.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 24 | 25.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 28.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 8 | 21.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 2 | 12.0 percentage of participants |
Comparison: Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.013295% CI: [1.17, 3.9]Regression, Logistic
Comparison: Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.127495% CI: [0.87, 3.02]Regression, Logistic
Comparison: Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001695% CI: [1.44, 4.76]Regression, Logistic
Comparison: Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.84, 6.03]Regression, Logistic
Comparison: Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.008995% CI: [1.2, 3.49]Regression, Logistic
Comparison: Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001295% CI: [1.42, 4.1]Regression, Logistic
Comparison: Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000695% CI: [1.45, 3.98]Regression, Logistic
Comparison: Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.92, 5.21]Regression, Logistic
Comparison: Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.020395% CI: [1.1, 3.06]Regression, Logistic
Comparison: Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.77, 4.86]Regression, Logistic
Comparison: Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.077595% CI: [0.95, 2.55]Regression, Logistic
Comparison: Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.006495% CI: [1.21, 3.21]Regression, Logistic
Secondary
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response
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. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Week 2, 4, 8, 12, 16, 24 and 32
Population: ITT population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure and 'Number analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 90% reduction | 4.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 90% reduction | 3.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 70% reduction | 10.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 30% reduction | 33.5 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 70% reduction | 17.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 90% reduction | 2.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 30% reduction | 45.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 50% reduction | 35.9 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 30% reduction | 58.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 70% reduction | 21.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 30% reduction | 56.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 50% reduction | 33.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 30% reduction | 65.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 90% reduction | 1.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 70% reduction | 15.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 50% reduction | 22.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 70% reduction | 5.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 90% reduction | 3.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 70% reduction | 8.5 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 50% reduction | 16.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 70% reduction | 17.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 90% reduction | 1.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 50% reduction | 43.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 50% reduction | 33.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 30% reduction | 50.5 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 90% reduction | 1.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 30% reduction | 56.6 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 50% reduction | 26.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 30% reduction | 54.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 30% reduction | 46.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 50% reduction | 27.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 70% reduction | 10.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 90% reduction | 2.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 30% reduction | 61.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 50% reduction | 33.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 70% reduction | 13.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 90% reduction | 3.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 30% reduction | 64.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 50% reduction | 37.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 70% reduction | 15.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 90% reduction | 4.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 30% reduction | 71.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 50% reduction | 46.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 70% reduction | 24.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 90% reduction | 8.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 30% reduction | 68.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 50% reduction | 49.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 70% reduction | 22.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 90% reduction | 7.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 30% reduction | 65.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 50% reduction | 45.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 70% reduction | 21.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 90% reduction | 5.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 50% reduction | 32.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 70% reduction | 12.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 90% reduction | 1.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 70% reduction | 24.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 50% reduction | 44.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 30% reduction | 42.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 90% reduction | 4.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 30% reduction | 61.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 50% reduction | 32.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 30% reduction | 68.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 90% reduction | 4.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 50% reduction | 18.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 50% reduction | 47.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 70% reduction | 15.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 90% reduction | 4.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 70% reduction | 23.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 50% reduction | 37.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 70% reduction | 15.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 90% reduction | 6.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 70% reduction | 23.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 50% reduction | 50.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 30% reduction | 58.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 90% reduction | 7.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 30% reduction | 71.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 90% reduction | 1.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 30% reduction | 68.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 90% reduction | 5.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 32: At least 30% reduction | 57.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 50% reduction | 47.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 70% reduction | 22.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 70% reduction | 6.7 percentage of participants |
Comparison: Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.021495% CI: [1.22, 11.66]Regression, Logistic
Comparison: Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000695% CI: [1.3, 2.59]Regression, Logistic
Comparison: Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.01695% CI: [1.08, 2.16]Regression, Logistic
Comparison: Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000895% CI: [1.34, 3.07]Regression, Logistic
Comparison: Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.511895% CI: [0.75, 1.8]Regression, Logistic
Comparison: Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.009395% CI: [1.25, 4.81]Regression, Logistic
Comparison: Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.301795% CI: [0.71, 3.01]Regression, Logistic
Comparison: Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.21695% CI: [0.6, 9.58]Regression, Logistic
Comparison: Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.717495% CI: [0.29, 6.08]Regression, Logistic
Comparison: Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.45, 2.87]Regression, Logistic
Comparison: Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000695% CI: [1.29, 2.54]Regression, Logistic
Comparison: Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.002495% CI: [1.23, 2.65]Regression, Logistic
Comparison: Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.49, 3.16]Regression, Logistic
Comparison: Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.037395% CI: [1.04, 3.14]Regression, Logistic
Comparison: Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.004695% CI: [1.27, 3.72]Regression, Logistic
Comparison: Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.068395% CI: [0.92, 9.47]Regression, Logistic
Comparison: Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000695% CI: [1.3, 2.58]Regression, Logistic
Comparison: Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.004895% CI: [1.16, 2.28]Regression, Logistic
Comparison: Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001295% CI: [1.27, 2.65]Regression, Logistic
Comparison: Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.68, 3.47]Regression, Logistic
Comparison: Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.053795% CI: [0.99, 2.74]Regression, Logistic
Comparison: Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000195% CI: [1.58, 4.13]Regression, Logistic
Comparison: Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.115595% CI: [0.82, 6.27]Regression, Logistic
Comparison: Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.027195% CI: [1.13, 7.96]Regression, Logistic
Comparison: Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000795% CI: [1.3, 2.63]Regression, Logistic
Comparison: Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001195% CI: [1.26, 2.56]Regression, Logistic
Comparison: Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000995% CI: [1.27, 2.52]Regression, Logistic
Comparison: Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.47, 2.91]Regression, Logistic
Comparison: Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.006495% CI: [1.18, 2.78]Regression, Logistic
Comparison: Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.01895% CI: [1.09, 2.58]Regression, Logistic
Comparison: Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000695% CI: [2.09, 15.08]Regression, Logistic
Comparison: Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.003495% CI: [1.64, 12.13]Regression, Logistic
Comparison: Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.002295% CI: [1.22, 2.44]Regression, Logistic
Comparison: Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001495% CI: [1.25, 2.5]Regression, Logistic
Comparison: Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000395% CI: [1.33, 2.64]Regression, Logistic
Comparison: Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.00395% CI: [1.19, 2.36]Regression, Logistic
Comparison: Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.075495% CI: [0.96, 2.24]Regression, Logistic
Comparison: Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.025395% CI: [1.06, 2.44]Regression, Logistic
Comparison: Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.009895% CI: [1.3, 6.83]Regression, Logistic
Comparison: Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.22395% CI: [0.72, 4.13]Regression, Logistic
Comparison: Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.020195% CI: [1.07, 2.12]Regression, Logistic
Comparison: Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.002195% CI: [1.22, 2.44]Regression, Logistic
Comparison: Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.002295% CI: [1.22, 2.43]Regression, Logistic
Comparison: Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000495% CI: [1.32, 2.64]Regression, Logistic
Comparison: Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.203195% CI: [0.86, 2.01]Regression, Logistic
Comparison: Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.086795% CI: [0.95, 2.18]Regression, Logistic
Comparison: Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.174695% CI: [0.77, 4.22]Regression, Logistic
Comparison: Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.103995% CI: [0.87, 4.57]Regression, Logistic
Secondary
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response
Percentage of participants with reduction in WOMAC physical function 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 physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Weeks 2, 4, 8, 12, 16, 24 and 32
Population: ITT population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure and 'Number analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 90% reduction | 3.5 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 90% reduction | 2.5 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 70% reduction | 7.5 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 30% reduction | 30.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 70% reduction | 14.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 90% reduction | 1.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 30% reduction | 36.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 50% reduction | 32.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 30% reduction | 51.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 70% reduction | 16.9 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 30% reduction | 53.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 50% reduction | 27.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 30% reduction | 60.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 90% reduction | 0.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 70% reduction | 12.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 50% reduction | 18.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 70% reduction | 3.9 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 90% reduction | 1.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 70% reduction | 6.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 50% reduction | 14.6 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 70% reduction | 14.6 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 90% reduction | 1.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 50% reduction | 40.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 50% reduction | 32.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 30% reduction | 45.6 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 90% reduction | 1.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 30% reduction | 51.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 50% reduction | 22.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 30% reduction | 51.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 30% reduction | 44.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 50% reduction | 19.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 70% reduction | 9.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 90% reduction | 2.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 30% reduction | 55.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 50% reduction | 28.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 70% reduction | 11.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 90% reduction | 2.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 30% reduction | 57.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 50% reduction | 33.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 70% reduction | 16.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 90% reduction | 5.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 30% reduction | 67.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 50% reduction | 43.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 70% reduction | 19.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 90% reduction | 6.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 30% reduction | 65.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 50% reduction | 42.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 70% reduction | 21.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 90% reduction | 6.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 30% reduction | 64.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 50% reduction | 41.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 70% reduction | 19.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 90% reduction | 5.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 50% reduction | 31.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 70% reduction | 11.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 90% reduction | 2.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 70% reduction | 18.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 50% reduction | 37.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 30% reduction | 38.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 90% reduction | 6.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 30% reduction | 59.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 50% reduction | 30.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 30% reduction | 68.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 90% reduction | 4.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 50% reduction | 18.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 50% reduction | 44.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 70% reduction | 12.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 90% reduction | 3.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 70% reduction | 17.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 50% reduction | 32.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 70% reduction | 11.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 24: At least 90% reduction | 5.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 70% reduction | 21.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 50% reduction | 43.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 4: At least 30% reduction | 53.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 90% reduction | 5.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 12: At least 30% reduction | 69.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 90% reduction | 1.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 30% reduction | 66.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 90% reduction | 4.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 32: At least 30% reduction | 53.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 16: At least 50% reduction | 44.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 8: At least 70% reduction | 15.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response | Week 2: At least 70% reduction | 5.3 percentage of participants |
Comparison: Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000395% CI: [1.33, 2.68]Regression, Logistic
Comparison: Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.028695% CI: [1.04, 2.1]Regression, Logistic
Comparison: Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.103195% CI: [0.93, 2.27]Regression, Logistic
Comparison: Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.203395% CI: [0.85, 2.1]Regression, Logistic
Comparison: Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.006495% CI: [1.34, 5.86]Regression, Logistic
Comparison: Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.370695% CI: [0.65, 3.23]Regression, Logistic
Comparison: Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.212195% CI: [0.61, 9.41]Regression, Logistic
Comparison: Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.485995% CI: [0.39, 7.11]Regression, Logistic
Comparison: Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.6, 3.17]Regression, Logistic
Comparison: Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.5, 2.96]Regression, Logistic
Comparison: Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.00295% CI: [1.27, 2.87]Regression, Logistic
Comparison: Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.53, 3.4]Regression, Logistic
Comparison: Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.010795% CI: [1.21, 4.14]Regression, Logistic
Comparison: Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.012695% CI: [1.18, 4.02]Regression, Logistic
Comparison: Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.151695% CI: [0.7, 10.26]Regression, Logistic
Comparison: Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.02195% CI: [1.25, 16.05]Regression, Logistic
Comparison: Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.003495% CI: [1.18, 2.31]Regression, Logistic
Comparison: Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.00195% CI: [1.26, 2.45]Regression, Logistic
Comparison: Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001495% CI: [1.27, 2.71]Regression, Logistic
Comparison: Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.46, 3.1]Regression, Logistic
Comparison: Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000795% CI: [1.49, 4.55]Regression, Logistic
Comparison: Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001895% CI: [1.39, 4.24]Regression, Logistic
Comparison: Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.01595% CI: [1.31, 12.79]Regression, Logistic
Comparison: Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.021195% CI: [1.22, 11.78]Regression, Logistic
Comparison: Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.43, 2.84]Regression, Logistic
Comparison: Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.55, 3.1]Regression, Logistic
Comparison: Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.47, 3]Regression, Logistic
Comparison: Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.46, 2.96]Regression, Logistic
Comparison: Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.01895% CI: [1.1, 2.76]Regression, Logistic
Comparison: Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.007295% CI: [1.18, 2.94]Regression, Logistic
Comparison: Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001595% CI: [2.49, 47.22]Regression, Logistic
Comparison: Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.004495% CI: [1.96, 37.96]Regression, Logistic
Comparison: Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001895% CI: [1.22, 2.43]Regression, Logistic
Comparison: Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001195% CI: [1.26, 2.5]Regression, Logistic
Comparison: Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.003595% CI: [1.19, 2.38]Regression, Logistic
Comparison: Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.002295% CI: [1.22, 2.43]Regression, Logistic
Comparison: Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.015595% CI: [1.11, 2.72]Regression, Logistic
Comparison: Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.154995% CI: [0.88, 2.2]Regression, Logistic
Comparison: Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.021295% CI: [1.18, 7.37]Regression, Logistic
Comparison: Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.037395% CI: [1.06, 6.57]Regression, Logistic
Comparison: Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000695% CI: [1.29, 2.57]Regression, Logistic
Comparison: Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.51, 3.02]Regression, Logistic
Comparison: Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.015295% CI: [1.09, 2.18]Regression, Logistic
Comparison: Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.001895% CI: [1.23, 2.45]Regression, Logistic
Comparison: Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.09795% CI: [0.93, 2.31]Regression, Logistic
Comparison: Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.343595% CI: [0.79, 1.98]Regression, Logistic
Comparison: Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.023695% CI: [1.17, 9.27]Regression, Logistic
Comparison: Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.029695% CI: [1.12, 8.81]Regression, Logistic
Secondary
Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was greater than or equal to (\>=) 50 percent and \>= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and PGA of OA (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).
Time frame: Weeks 2, 4, 8, 12, 16, 24 and 32
Population: ITT population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here 'Overall number of participants analyzed' = participants who were evaluable for this outcome measure and 'Number analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 4 | 53.0 percentage of participants |
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 16 | 64.4 percentage of participants |
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 12 | 68.7 percentage of participants |
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 2 | 44.1 percentage of participants |
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 32 | 74.0 percentage of participants |
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 24 | 65.1 percentage of participants |
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 8 | 61.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 12 | 80.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 2 | 63.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 4 | 74.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 8 | 75.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 16 | 78.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 24 | 76.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 32 | 66.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 16 | 76.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 4 | 71.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 32 | 63.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 24 | 77.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 12 | 81.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 8 | 75.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 2 | 54.9 percentage of participants |
Comparison: Week 2: Odds ratio and 95 percent (%) confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.59, 3.14]Regression, Logistic
Comparison: Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.008595% CI: [1.12, 2.18]Regression, Logistic
Comparison: Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.89, 3.88]Regression, Logistic
Comparison: Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: <0.000195% CI: [1.62, 3.28]Regression, Logistic
Comparison: Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000595% CI: [1.33, 2.75]Regression, Logistic
Comparison: Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000595% CI: [1.32, 2.73]Regression, Logistic
Comparison: Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000995% CI: [1.31, 2.86]Regression, Logistic
Comparison: Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000895% CI: [1.32, 2.89]Regression, Logistic
Comparison: Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.000295% CI: [1.41, 3.01]Regression, Logistic
Comparison: Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatmentp-value: 0.002295% CI: [1.23, 2.57]Regression, Logistic
Comparison: Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatmentp-value: 0.003295% CI: [1.21, 2.54]Regression, Logistic
Comparison: Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatmentp-value: 0.001395% CI: [1.27, 2.69]Regression, Logistic
Secondary
Percentage of Participants With Adjudicated Joint Safety Outcomes
Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive OA (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.
Time frame: Baseline up to Week 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, 'Overall number of participants analyzed' signifies participants analyzed by adjudication committee.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 1 | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Primary Osteonecrosis | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 2 | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Subchondral Insufficiency Fracture | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Composite Joint Safety Endpoint | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Pathological Fracture | 0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 1 | 1.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Composite Joint Safety Endpoint | 1.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA | 1.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 2 | 0.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Primary Osteonecrosis | 0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Pathological Fracture | 0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Subchondral Insufficiency Fracture | 0.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Primary Osteonecrosis | 0.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA | 2.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Subchondral Insufficiency Fracture | 0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Pathological Fracture | 0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 2 | 1.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 1 | 1.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Composite Joint Safety Endpoint | 3.2 percentage of participants |
Secondary
Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 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. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. 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, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Baseline, Weeks 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Overall number of participants analyzed' = Participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=80% | 11.4 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=40% | 44.8 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=80% | 10.0 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=30% | 56.2 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=30% | 56.6 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=90% | 3.2 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: =100% | 1.1 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=20% | 65.8 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: =100% | 1.1 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=70% | 17.8 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=10% | 70.8 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >0% | 80.1 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=40% | 45.2 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=90% | 3.2 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=60% | 24.9 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=50% | 35.9 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=20% | 66.9 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >0% | 81.9 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=60% | 27.0 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=10% | 77.6 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=50% | 33.8 percentage of Participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=70% | 17.1 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=50% | 45.4 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >0% | 91.8 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=10% | 87.6 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=20% | 79.4 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=30% | 68.1 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=40% | 57.8 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=50% | 49.6 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=60% | 34.4 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=70% | 22.3 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=80% | 14.5 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=90% | 7.4 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: =100% | 1.8 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >0% | 89.7 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=10% | 83.0 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=20% | 76.2 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=30% | 65.6 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=40% | 55.0 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=60% | 33.3 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=70% | 21.3 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=80% | 12.1 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=90% | 5.3 percentage of Participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: =100% | 0.7 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=30% | 68.7 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=70% | 24.3 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=10% | 82.0 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=40% | 59.2 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=60% | 36.6 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=50% | 47.5 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=50% | 47.9 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=40% | 59.9 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: =100% | 2.8 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=60% | 36.6 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=30% | 68.7 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=90% | 6.0 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=70% | 23.2 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >0% | 88.4 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: =100% | 3.2 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=20% | 76.1 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=10% | 83.5 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=90% | 4.9 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >0% | 89.4 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=20% | 76.8 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 16: >=80% | 14.4 percentage of Participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24 | Week 24: >=80% | 14.1 percentage of Participants |
Secondary
Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24
Percentage of participants with cumulative reduction (as percent) (greater than 0 %; \>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; =100 %) in WOMAC physical function subscale from Baseline to Weeks 16 and 24 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Baseline, Weeks 16 and 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Overall number of participants analyzed' = Participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=80% | 6.4 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=40% | 41.3 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=80% | 7.1 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=30% | 53.0 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=30% | 51.2 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=90% | 2.5 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: =100% | 0 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=20% | 61.6 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: =100% | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=70% | 14.6 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=10% | 70.1 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=0% | 79.7 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=40% | 44.1 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=90% | 1.8 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=60% | 21.0 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=50% | 32.0 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=20% | 61.6 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=0% | 84.7 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=60% | 20.3 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=10% | 75.1 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=50% | 32.4 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=70% | 14.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=50% | 41.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=0% | 93.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=10% | 87.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=20% | 73.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=30% | 65.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=40% | 55.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=50% | 42.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=60% | 30.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=70% | 21.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=80% | 12.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=90% | 6.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: =100% | 0.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=0% | 89.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=10% | 85.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=20% | 74.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=30% | 64.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=40% | 51.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=60% | 30.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=70% | 19.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=80% | 10.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=90% | 5.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: =100% | 0.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=30% | 68.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=70% | 18.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=10% | 83.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=40% | 57.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=60% | 30.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=50% | 44.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=50% | 44.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=40% | 56.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: =100% | 1.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=60% | 30.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=30% | 66.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=90% | 5.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=70% | 17.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=0% | 90.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: =100% | 1.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=20% | 73.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=10% | 84.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=90% | 6.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=0% | 93.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=20% | 78.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 16: >=80% | 11.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24 | Week 24: >=80% | 10.2 percentage of participants |
Secondary
Percentage of Participants With Total Joint Replacements
Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery.
Time frame: Baseline up to Week 48
Population: The safety population was defined as all participants treated with tanezumab or placebo subcutaneously.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Total Joint Replacements | 6.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Total Joint Replacements | 7.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Total Joint Replacements | 7.0 percentage of participants |
Secondary
Time to Discontinuation Due to Lack of Efficacy
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.
Time frame: Baseline up to Week 24
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Overall number of participants analyzed' signifies participants who discontinued from the study due to lack of efficacy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tanezumab 2.5 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tanezumab 5 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
Comparison: Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.p-value: 0.0002Log Rank
Comparison: Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.p-value: 0.0007Log Rank
Secondary
Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline
WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Time frame: Baseline
Population: The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Work Time Missed | 9.7 units on a scale | Standard Deviation 23.46 |
| Placebo | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Impairment While Working | 56.5 units on a scale | Standard Deviation 22.26 |
| Placebo | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Overall Work Impairment | 59.3 units on a scale | Standard Deviation 21.32 |
| Placebo | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Activity Impairment | 66.6 units on a scale | Standard Deviation 13.35 |
| Tanezumab 2.5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Activity Impairment | 67.7 units on a scale | Standard Deviation 15.53 |
| Tanezumab 2.5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Work Time Missed | 5.6 units on a scale | Standard Deviation 18.33 |
| Tanezumab 2.5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Overall Work Impairment | 60.2 units on a scale | Standard Deviation 21.2 |
| Tanezumab 2.5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Impairment While Working | 58.9 units on a scale | Standard Deviation 21.81 |
| Tanezumab 5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Activity Impairment | 67.5 units on a scale | Standard Deviation 13.26 |
| Tanezumab 5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Impairment While Working | 57.4 units on a scale | Standard Deviation 18.44 |
| Tanezumab 5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Overall Work Impairment | 58.3 units on a scale | Standard Deviation 18.89 |
| Tanezumab 5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Work Time Missed | 6.9 units on a scale | Standard Deviation 21.33 |