Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
Keywords
osteoarthritis of the knee, osteoarthritis of the hip, nerve growth factor inhibitor, tanezumab
Brief summary
The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg) at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study also evaluates the safety of the treatment regimens.
Interventions
OTHERPlacebo
Patient receives one dose of placebo to match tanezumab subcutaneously on Day 1 and one dose of placebo to match tanezumab subcutaneously at Week 8.
BIOLOGICALTanezumab 2.5 mg
Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 2.5 mg subcutaneously at Week 8.
BIOLOGICALTanezumab 2.5mg/5mg
Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray * Documented history that subject tried the following medications and had insufficient pain relief or is cannot take or tolerate them: acetaminophen, NSAIDs and either tramadol or opioids * Meet the protocol requirements for pain at screening and pain, physical function and patient global assessment of osteoarthritis at baseline * Willing to discontinue all pain medications except study medication and rescue medication during the course of the study and use those as directed per protocol * Women able to have children must agree to use 2 forms of contraception during the study
Exclusion criteria
* Body Mass Index (BMI) greater than 39 * History of diseases other than osteoarthritis in a shoulder, hip or knee (example, rheumatoid arthritis, gout, joint infections, osteonecrosis) * Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or certain types of fractures * Patients who have had significant trauma or surgery to a knee, hip or shoulder within the previous year * Planned surgical procedure during the study * Patients who are largely or wholly incapacitated (example bedridden or confined to a wheelchair, permitting little or no self-care) * Patients who would be unwilling or unable to undergo joint replacement surgery if one eventually became necessary * Patients with significant conditions other than osteoarthritis that could interfere with assessment of pain in the joints (example fibromyalgia, lupus erythematosus) * Patients with significant heart, neurological or psychiatric diseases * Patients who had cancer other than certain skin cancers within the past 5 years * Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2 years * Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | Baseline, Week 16 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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) 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) Physical Function Subscale at Week 16 | Baseline, Week 16 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 osteoarthritis 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 of 0 (minimum 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 Week 16 | Baseline, Week 16 | PGA of osteoarthritis 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 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. 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 osteoarthritis 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 of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated maximum difficulty/worse physical function. |
| Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Baseline, Weeks 2, 4, 8 and 12 | PGA of osteoarthritis 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 24 | Baseline, Week 24 | PGA of osteoarthritis 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 and 24 | 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 greater or equal to (\>=) 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 osteoarthritis (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 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 and 24 | Percentage of participants with reduction in WOMAC pain intensity of at least (\>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16 and 24 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 osteoarthritis. 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) of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF. |
| Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | Baseline to Week 16 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 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 Week 16 were reported, participants (%) are reported more than once in categories specified. 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 and 24 | PGA of osteoarthritis 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 osteoarthritis were reported. 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 Percent (%), >=50%, >=70% and >=90% Response | Weeks 2, 4, 8, 12, 16 and 24 | Percentage of participants with reduction in WOMAC physical function of at least (\>=) 30%, 50%, 70% and 90% at weeks 2, 4, 8, 12, 16 and 24 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 osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours,calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum 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 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | Baseline to Week 16 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty),higher scores indicate extreme difficulty/worse physical function. 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 Week 16 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 and 16 | Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | 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 4-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 20 and 24 | Baseline, Weeks 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) weekly beginning at Week 16. Higher scores indicated higher pain. Data represents averages of the values reported during the 4-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 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 osteoarthritis. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 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 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. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 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 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 osteoarthritis 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 \[minimum difficulty\] 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 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 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 \[minimum difficulty\] 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 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 osteoarthritis 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 Walking on a Flat Surface) 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 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 (Pain When Going up or Down Stairs) 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 osteoarthritis 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 (Pain When Going up or Down Stairs) 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 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 osteoarthritis 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) Scores at Week 16 | Baseline and Week 16 | WPAI is 6-question participant rated questionnaire to determine the impact of osteoarthritis 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 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline, Weeks 8 and 16 | 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 patient 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 patient reports greater levels of problems across the five dimensions. |
| European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Baseline, Weeks 8 and 16 | 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 \<=1. The Overall health utility score for a patient 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 patient reports greater levels of problems across the five dimensions. |
| Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline, Weeks 24 and 40 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). 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 24 and 40 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who visited the emergency room due to osteoarthritis (OA). |
| Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline, Weeks 24 and 40 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). 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 24 and 40 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). 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 24 and 40 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). 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 24 and 40 | Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). 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 24 and 40 | Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 24 and Week 40. 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 24 and 40 | Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 24 and Week 40. Domain evaluated was duration since quitting job due to OA. |
| Number of Participants Who Withdrew Due to Lack of Efficacy | Baseline up to Week 16 | Number of participants who withdrew from treatment due to lack of efficacy have been reported here. |
| Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 16 | 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 and 16 | Week 2, 4, 8, 12 and 16 | In case of inadequate pain relief, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 16. 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 24 | Week 24 | In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 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 participants with any use of rescue medication during the 4 weeks up to the particular study week were summarized. |
| Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 2, 4, 8, 12, 16 | In case of inadequate pain relief during the treatment period, acetaminophen up to 3000 mg per day up to 3 days in a week 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 Use at Week 24 | Week 24 | In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 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 the particular study week were summarized. |
| Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 2, 4, 8, 12, 16 | In case of inadequate pain relief , acetaminophen up to 3000 mg per day up to 3 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) | Baseline up to Week 40 | 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 40 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) | Baseline up to Week 40 | 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 40 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator. |
| Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | Baseline up to Week 40 | Primary Abnormality criteria: hemoglobin; hematocrit; RBC count \[less than{\<}0.8\* lower limit of normal\[LLN\]; 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; 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;Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN, specific gravity \<1.003, \>1.030; pH\<4.5, \>8; Urine Leukocytes \>=20. |
| Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | Baseline up to Week 40 | 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; 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; Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN; Urine erythrocytes \>=20. |
| Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | Baseline, Weeks 2, 4, 8, 12, 16, 24, 40 | Measurement of BP included sitting systolic (SBP) and diastolic BP (DBP). |
| Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Baseline, Weeks 2, 4, 8, 12, 16, 24 and 40 | Heart rate was measured at sitting position. |
| Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | Baseline, Weeks 16, 40 | 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 16 and 40 | Baseline, Weeks 16 and 40 | — |
| Percentage of Participants With Adjudicated Joint Safety Outcomes | Baseline up to Week 40 | Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (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 Weeks 2, 4, 8 and 12 | Baseline, Weeks 2, 4, 8 and 12 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Baseline, Weeks 2, 4, 8,12,16, 24 and 40 | 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 Confirmed Orthostatic Hypotension | Baseline up to Week 40 | 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 Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Baseline, Weeks 24 and 40 | 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 Anti-Tanezumab Antibodies | Baseline, Weeks 8,16, 24 and 40 | 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 Total Joint Replacements | Baseline up to Week 40 | Percentage of participants who underwent total knee, hip or shoulder joint replacement surgery. |
| 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. 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 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) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Baseline, Weeks 2, 4, 8 and 12 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 osteoarthritis 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 of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. |
Countries
Canada, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to tanezumab (RN624 or PF-04383119) injection administered subcutaneously on Day 1 (Baseline) and Week 8. | 232 |
| Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Week 8. | 231 |
| Tanezumab 2.5mg/5mg Tanezumab (RN624 or PF-04383119) 2.5 mg injection administered subcutaneously on Day 1 (Baseline) and Tanezumab 5 mg injection administered subcutaneously on Week 8. | 233 |
| Total | 696 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 2 |
| Overall Study | Death | 0 | 0 | 2 |
| Overall Study | Lack of Efficacy | 4 | 6 | 6 |
| Overall Study | Lost to Follow-up | 5 | 5 | 7 |
| Overall Study | Other | 15 | 11 | 10 |
| Overall Study | Protocol Violation | 1 | 1 | 0 |
| Overall Study | Randomized but not treated | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 13 | 13 |
Baseline characteristics
| Characteristic | Placebo | Tanezumab 2.5 mg | Tanezumab 2.5mg/5mg | Total |
|---|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 9.8 | 60.9 years STANDARD_DEVIATION 10 | 61.2 years STANDARD_DEVIATION 9 | 60.83 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants | 43 Participants | 40 Participants | 119 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 196 Participants | 188 Participants | 193 Participants | 577 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 5 Participants | 8 Participants | 26 Participants |
| Race/Ethnicity, Customized Black or African American | 60 Participants | 43 Participants | 50 Participants | 153 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 5 Participants | 5 Participants | 13 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 156 Participants | 178 Participants | 170 Participants | 504 Participants |
| Sex: Female, Male Female | 157 Participants | 145 Participants | 151 Participants | 453 Participants |
| Sex: Female, Male Male | 75 Participants | 86 Participants | 82 Participants | 243 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 232 | 0 / 231 | 2 / 233 |
| other Total, other adverse events | 143 / 232 | 155 / 231 | 141 / 233 |
| serious Total, serious adverse events | 9 / 232 | 7 / 231 | 11 / 233 |
Outcome results
Primary
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16
PGA of osteoarthritis 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 16
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 Patient's Global Assessment (PGA) of Osteoarthritis at Week 16 | -0.65 units on a scale | Standard Error 0.08 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16 | -0.87 units on a scale | Standard Error 0.08 |
| Tanezumab 2.5/5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16 | -0.90 units on a scale | Standard Error 0.08 |
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: 0.010995% CI: [-0.39, -0.05]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: 0.003895% CI: [-0.41, -0.08]ANCOVA
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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) of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Week 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 | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | -2.64 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | -3.23 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | -3.37 units on a scale | Standard Error 0.22 |
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: 0.012995% CI: [-1.07, -0.13]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: 0.002395% CI: [-1.2, -0.26]ANCOVA
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 osteoarthritis 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 of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Time frame: Baseline, Week 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 | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | -2.56 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | -3.22 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | -3.45 units on a scale | Standard Error 0.22 |
Comparison: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed data sets 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: 0.006595% CI: [-1.14, -0.19]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: 0.000295% CI: [-1.37, -0.42]ANCOVA
Secondary
Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16
In case of inadequate pain relief , acetaminophen up to 3000 mg per day up to 3 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: Week 2, 4, 8, 12, 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 | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 16 | 2303.7 milligrams | Standard Error 747.74 |
| Placebo | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 2 | 3226.0 milligrams | Standard Error 698.1 |
| Placebo | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 4 | 3033.2 milligrams | Standard Error 774.34 |
| Placebo | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 8 | 2608.6 milligrams | Standard Error 706.6 |
| Placebo | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 12 | 2121.2 milligrams | Standard Error 698.93 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 8 | 2385.9 milligrams | Standard Error 633.42 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 12 | 1810.1 milligrams | Standard Error 567.14 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 2 | 3139.1 milligrams | Standard Error 655.37 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 16 | 2846.9 milligrams | Standard Error 906.15 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 4 | 2815.6 milligrams | Standard Error 703.9 |
| Tanezumab 2.5/5 mg | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 12 | 1633.4 milligrams | Standard Error 506.13 |
| Tanezumab 2.5/5 mg | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 4 | 2005.3 milligrams | Standard Error 484.54 |
| Tanezumab 2.5/5 mg | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 8 | 2104.2 milligrams | Standard Error 556.57 |
| Tanezumab 2.5/5 mg | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 16 | 2166.0 milligrams | Standard Error 670.55 |
| Tanezumab 2.5/5 mg | Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16 | Week 2 | 2537.6 milligrams | Standard Error 530.44 |
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: 0.916495% CI: [0.58, 1.62]Negative binomial model
p-value: 0.354295% CI: [0.47, 1.31]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: 0.806595% CI: [0.51, 1.68]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: 0.175295% CI: [0.36, 1.2]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: 0.783795% CI: [0.48, 1.73]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: 0.506295% CI: [0.43, 1.52]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: 0.682195% CI: [0.4, 1.82]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: 0.503295% CI: [0.36, 1.65]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: 0.579695% CI: [0.58, 2.61]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: 0.872595% CI: [0.44, 2]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 and 16
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 4-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 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 for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 4 | -1.88 units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 16 | -2.30 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 8 | -2.29 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 6 | -2.17 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 1 | -1.27 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 and 16 | Change at Week 12 | -2.58 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 3 | -1.95 units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 2 | -1.68 units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 10 | -2.51 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 6 | -2.89 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 1 | -1.60 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 and 16 | Change at Week 2 | -2.32 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 and 16 | Change at Week 3 | -2.61 units on a scale | Standard Error 0.2 |
| 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 and 16 | Change at Week 4 | -2.79 units on a scale | Standard Error 0.2 |
| 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 and 16 | Change at Week 8 | -2.73 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 10 | -3.19 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 12 | -3.30 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 16 | -2.98 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 3 | -2.71 units on a scale | Standard Error 0.2 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 1 | -1.65 units on a scale | Standard Error 0.15 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 10 | -3.19 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 2 | -2.23 units on a scale | Standard Error 0.19 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 16 | -3.12 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 6 | -2.85 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 4 | -2.82 units on a scale | Standard Error 0.2 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 12 | -3.33 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16 | Change at Week 8 | -2.70 units on a scale | Standard Error 0.2 |
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 diary average pain as covariate, and study site as a random effect.p-value: 0.031995% CI: [-0.63, -0.03]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 diary average pain as covariate, and study site as a random effect.p-value: 0.013995% CI: [-0.68, -0.08]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 diary average pain as covariate, and study site as a random effect.p-value: 0.001195% CI: [-1.03, -0.25]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 diary average pain as covariate, and study site as a random effect.p-value: 0.005395% CI: [-0.93, -0.16]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 diary average pain as covariate, and study site as a random effect.p-value: 0.001495% CI: [-1.08, -0.26]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 diary average pain as covariate, and study site as a random effect.p-value: 0.000295% CI: [-1.17, -0.36]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 diary average pain as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.33, -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 diary average pain as covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.36, -0.52]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 diary average pain as covariate, and study site as a random effect.p-value: 0.001595% CI: [-1.16, -0.28]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 diary average pain as covariate, and study site as a random effect.p-value: 0.002395% CI: [-1.12, -0.24]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 diary average pain as covariate, and study site as a random effect.p-value: 0.051295% CI: [-0.89, 0]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 diary average pain as covariate, and study site as a random effect.p-value: 0.069395% CI: [-0.85, 0.03]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 diary average pain as covariate, and study site as a random effect.p-value: 0.004395% CI: [-1.14, -0.21]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 diary average pain as covariate, and study site as a random effect.p-value: 0.004195% CI: [-1.13, -0.21]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 diary average pain as covariate, and study site as a random effect.p-value: 0.002495% CI: [-1.19, -0.26]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 diary average pain as covariate, and study site as a random effect.p-value: 0.001595% CI: [-1.22, -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 diary average pain as covariate, and study site as a random effect.p-value: 0.006395% CI: [-1.16, -0.19]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 diary average pain as covariate, and study site as a random effect.p-value: 0.000895% CI: [-1.3, -0.34]ANCOVA
Secondary
Change From Baseline for Average Pain Score in the Index Joint at Weeks 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) weekly beginning at Week 16. Higher scores indicated higher pain. Data represents averages of the values reported during the 4-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 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). 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 20 and 24 | Change at Week 20 | -2.58 units on a scale | Standard Deviation 2.34 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24 | Baseline | 7.27 units on a scale | Standard Deviation 1.33 |
| Placebo | Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24 | Change at Week 24 | -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 20 and 24 | Change at Week 20 | -2.76 units on a scale | Standard Deviation 2.39 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24 | Baseline | 6.89 units on a scale | Standard Deviation 1.63 |
| Tanezumab 2.5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24 | Change at Week 24 | -2.14 units on a scale | Standard Deviation 2.37 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24 | Baseline | 7.13 units on a scale | Standard Deviation 1.48 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24 | Change at Week 24 | -2.70 units on a scale | Standard Deviation 2.69 |
| Tanezumab 2.5/5 mg | Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24 | Change at Week 20 | -3.26 units on a scale | Standard Deviation 2.65 |
Secondary
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40
Measurement of BP included sitting systolic (SBP) and diastolic BP (DBP).
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 40
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, 40 | SBP:Change at Week 12 | -0.4 millimeters of mercury (mmHg) | Standard Deviation 13.9 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 2 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 10.77 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 4 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 10.98 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 8 | -0.4 millimeters of mercury (mmHg) | Standard Deviation 12.12 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP: Baseline | 126.6 millimeters of mercury (mmHg) | Standard Deviation 11.11 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 16 | -0.4 millimeters of mercury (mmHg) | Standard Deviation 10.79 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 24 | 0.8 millimeters of mercury (mmHg) | Standard Deviation 12.05 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 40 | 0.4 millimeters of mercury (mmHg) | Standard Deviation 12.61 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP: Baseline | 77.7 millimeters of mercury (mmHg) | Standard Deviation 8.25 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 2 | 0.2 millimeters of mercury (mmHg) | Standard Deviation 7.41 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 4 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 7.55 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 8 | -0.4 millimeters of mercury (mmHg) | Standard Deviation 7.41 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 12 | -0.3 millimeters of mercury (mmHg) | Standard Deviation 8.59 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 16 | 0.2 millimeters of mercury (mmHg) | Standard Deviation 6.97 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 24 | 0.5 millimeters of mercury (mmHg) | Standard Deviation 7.85 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 40 | -1.4 millimeters of mercury (mmHg) | Standard Deviation 8.33 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 16 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 11.71 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 24 | 0.1 millimeters of mercury (mmHg) | Standard Deviation 13.04 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 40 | -0.9 millimeters of mercury (mmHg) | Standard Deviation 12.66 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 16 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 7.97 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP: Baseline | 78.0 millimeters of mercury (mmHg) | Standard Deviation 8.47 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 2 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 7.6 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 40 | -1.4 millimeters of mercury (mmHg) | Standard Deviation 9.64 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 4 | -1.6 millimeters of mercury (mmHg) | Standard Deviation 8.36 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP: Baseline | 126.4 millimeters of mercury (mmHg) | Standard Deviation 12.2 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 24 | -0.5 millimeters of mercury (mmHg) | Standard Deviation 8.74 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 2 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 11.2 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 8 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 7.9 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 4 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 11.38 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 8 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 12.08 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 12 | -3.8 millimeters of mercury (mmHg) | Standard Deviation 11.93 |
| Tanezumab 2.5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 12 | -2.5 millimeters of mercury (mmHg) | Standard Deviation 8.13 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 4 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 7.52 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 16 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 12.52 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 12 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 8.49 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 4 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 11.89 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 24 | 0.7 millimeters of mercury (mmHg) | Standard Deviation 11.89 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 40 | -0.6 millimeters of mercury (mmHg) | Standard Deviation 8.64 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP: Baseline | 127.3 millimeters of mercury (mmHg) | Standard Deviation 12.85 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 40 | -0.1 millimeters of mercury (mmHg) | Standard Deviation 11.3 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 8 | -0.1 millimeters of mercury (mmHg) | Standard Deviation 8.18 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 12 | -1.5 millimeters of mercury (mmHg) | Standard Deviation 12.33 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP: Baseline | 77.9 millimeters of mercury (mmHg) | Standard Deviation 8.79 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 16 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 8.55 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 2 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 11.12 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 2 | -0.6 millimeters of mercury (mmHg) | Standard Deviation 7.56 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | SBP:Change at Week 8 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 12.06 |
| Tanezumab 2.5/5 mg | Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40 | DBP:Change at Week 24 | 0.2 millimeters of mercury (mmHg) | Standard Deviation 9.07 |
Secondary
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40
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 16, 40
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 16 and 40 | PR Interval:Change at Week 16 | -1.7 millisecond | Standard Deviation 12.17 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | RR Interval:Change at Week 16 | -20.4 millisecond | Standard Deviation 114.08 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | RR Interval:Change at Week 40 | -31.6 millisecond | Standard Deviation 113.49 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | PR Interval: Baseline | 168.4 millisecond | Standard Deviation 26.2 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | RR Interval: Baseline | 932.4 millisecond | Standard Deviation 137.58 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | PR Interval:Change at Week 40 | -0.9 millisecond | Standard Deviation 13.63 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QRS Interval: Baseline | 94.8 millisecond | Standard Deviation 14.63 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QRS Interval:Change at Week 16 | -0.3 millisecond | Standard Deviation 6.53 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QRS Interval:Change at Week 40 | -0.9 millisecond | Standard Deviation 7.36 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QT Interval: Baseline | 401.3 millisecond | Standard Deviation 27.2 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QT Interval:Change at Week 16 | -2.7 millisecond | Standard Deviation 21.24 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QT Interval:Change at Week 40 | -6.1 millisecond | Standard Deviation 21.14 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCB Interval: Baseline | 417.4 millisecond | Standard Deviation 21.67 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCB Interval:Change at Week 16 | 1.9 millisecond | Standard Deviation 16.59 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCB Interval:Change at Week 40 | 1.1 millisecond | Standard Deviation 15.97 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCF Interval: Baseline | 411.8 millisecond | Standard Deviation 18.93 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCF Interval:Change at Week 16 | 0.3 millisecond | Standard Deviation 13.85 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCF Interval:Change at Week 40 | -1.4 millisecond | Standard Deviation 13.4 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCF Interval:Change at Week 40 | -1.9 millisecond | Standard Deviation 14.08 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | RR Interval: Baseline | 927.3 millisecond | Standard Deviation 140.92 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QT Interval: Baseline | 401.5 millisecond | Standard Deviation 28.82 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCB Interval: Baseline | 418.8 millisecond | Standard Deviation 20.45 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | RR Interval:Change at Week 16 | -13.1 millisecond | Standard Deviation 119.83 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCB Interval:Change at Week 40 | 0.3 millisecond | Standard Deviation 17.6 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCF Interval: Baseline | 412.7 millisecond | Standard Deviation 18.36 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | RR Interval:Change at Week 40 | -28.5 millisecond | Standard Deviation 116.77 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QT Interval:Change at Week 16 | -1.7 millisecond | Standard Deviation 22.08 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCF Interval:Change at Week 16 | 0.2 millisecond | Standard Deviation 14.54 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | PR Interval: Baseline | 163.2 millisecond | Standard Deviation 25.73 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QRS Interval:Change at Week 40 | -0.7 millisecond | Standard Deviation 7.71 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCB Interval:Change at Week 16 | 1.2 millisecond | Standard Deviation 17.25 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | PR Interval:Change at Week 16 | 1.8 millisecond | Standard Deviation 12.08 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QRS Interval:Change at Week 16 | -0.4 millisecond | Standard Deviation 7.47 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QT Interval:Change at Week 40 | -6.1 millisecond | Standard Deviation 20.67 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | PR Interval:Change at Week 40 | -1.2 millisecond | Standard Deviation 13.37 |
| Tanezumab 2.5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QRS Interval: Baseline | 94.6 millisecond | Standard Deviation 11.69 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | PR Interval:Change at Week 40 | -0.3 millisecond | Standard Deviation 12.65 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QRS Interval: Baseline | 93.8 millisecond | Standard Deviation 12.56 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QRS Interval:Change at Week 16 | -1.1 millisecond | Standard Deviation 6.99 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCB Interval:Change at Week 40 | -2.0 millisecond | Standard Deviation 16.43 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QRS Interval:Change at Week 40 | -1.6 millisecond | Standard Deviation 7.76 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCF Interval:Change at Week 40 | -3.5 millisecond | Standard Deviation 14.34 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QT Interval: Baseline | 397.9 millisecond | Standard Deviation 26.26 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QT Interval:Change at Week 16 | -1.8 millisecond | Standard Deviation 21.2 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCF Interval: Baseline | 411.4 millisecond | Standard Deviation 18.84 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QT Interval:Change at Week 40 | -6.3 millisecond | Standard Deviation 22.68 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | RR Interval: Baseline | 911.0 millisecond | Standard Deviation 128.93 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | RR Interval:Change at Week 16 | -10.1 millisecond | Standard Deviation 115.78 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCB Interval: Baseline | 418.7 millisecond | Standard Deviation 21.55 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | RR Interval:Change at Week 40 | -22.1 millisecond | Standard Deviation 114.23 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | PR Interval: Baseline | 162.9 millisecond | Standard Deviation 26.83 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | PR Interval:Change at Week 16 | -0.3 millisecond | Standard Deviation 12.41 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCB Interval:Change at Week 16 | 0.4 millisecond | Standard Deviation 17.52 |
| Tanezumab 2.5/5 mg | Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40 | QTCF Interval:Change at Week 16 | -0.4 millisecond | Standard Deviation 14.44 |
Secondary
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40
Time frame: Baseline, Weeks 16 and 40
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 16 and 40 | Change at Week 16 | 1.3 beats per minute | Standard Deviation 8.68 |
| Placebo | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40 | Baseline | 65.8 beats per minute | Standard Deviation 9.78 |
| Placebo | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40 | Change at Week 40 | 2.5 beats per minute | Standard Deviation 8.55 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40 | Change at Week 16 | 0.9 beats per minute | Standard Deviation 8.81 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40 | Baseline | 66.3 beats per minute | Standard Deviation 10.97 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40 | Change at Week 40 | 2.2 beats per minute | Standard Deviation 9.13 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40 | Baseline | 67.2 beats per minute | Standard Deviation 9.8 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40 | Change at Week 40 | 1.5 beats per minute | Standard Deviation 8.88 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40 | Change at Week 16 | 0.8 beats per minute | Standard Deviation 8.74 |
Secondary
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40
Heart rate was measured at sitting position.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24 and 40
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, 40 | Baseline | 70.9 beats per minute | Standard Deviation 8.96 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 2 | 0.7 beats per minute | Standard Deviation 7.71 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 4 | 0.9 beats per minute | Standard Deviation 7.76 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 8 | 0.2 beats per minute | Standard Deviation 8.65 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 12 | 0.6 beats per minute | Standard Deviation 8.24 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 16 | -0.0 beats per minute | Standard Deviation 8.47 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 24 | 0.7 beats per minute | Standard Deviation 9.11 |
| Placebo | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 40 | 0.7 beats per minute | Standard Deviation 8.72 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 4 | 0.5 beats per minute | Standard Deviation 7.56 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 24 | 0.4 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, 40 | Change at Week 8 | -0.3 beats per minute | Standard Deviation 8.33 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 12 | 1.1 beats per minute | Standard Deviation 8.07 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 16 | 0.3 beats per minute | Standard Deviation 8.82 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Baseline | 71.4 beats per minute | Standard Deviation 10.05 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 2 | 1.1 beats per minute | Standard Deviation 8.4 |
| Tanezumab 2.5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 40 | 0.5 beats per minute | Standard Deviation 10.11 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 4 | 0.8 beats per minute | Standard Deviation 8.6 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 2 | 0.3 beats per minute | Standard Deviation 8.12 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Baseline | 72.5 beats per minute | Standard Deviation 9.76 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 8 | -0.1 beats per minute | Standard Deviation 7.91 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 24 | 0.6 beats per minute | Standard Deviation 8.42 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 16 | -0.6 beats per minute | Standard Deviation 8.32 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 12 | 0.0 beats per minute | Standard Deviation 8.81 |
| Tanezumab 2.5/5 mg | Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40 | Change at Week 40 | 0.2 beats per minute | Standard Deviation 8.49 |
Secondary
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40
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 and 40
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 Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Baseline | 1.09 units on a scale | Standard Deviation 2.6 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 2 | -0.21 units on a scale | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 4 | -0.17 units on a scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 8 | -0.14 units on a scale | Standard Deviation 1.55 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 12 | -0.14 units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 16 | -0.20 units on a scale | Standard Deviation 1.71 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 24 | -0.27 units on a scale | Standard Deviation 1.73 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 40 | -0.25 units on a scale | Standard Deviation 1.71 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 4 | -0.15 units on a scale | Standard Deviation 2.37 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 24 | -0.16 units on a scale | Standard Deviation 1.83 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 8 | -0.22 units on a scale | Standard Deviation 2.06 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 12 | -0.31 units on a scale | Standard Deviation 2.37 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 16 | -0.24 units on a scale | Standard Deviation 2.28 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Baseline | 2.01 units on a scale | Standard Deviation 4.75 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 2 | -0.14 units on a scale | Standard Deviation 1.64 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 40 | -0.25 units on a scale | Standard Deviation 2.16 |
| Tanezumab 2.5/5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 4 | -0.32 units on a scale | Standard Deviation 1.88 |
| Tanezumab 2.5/5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 2 | -0.31 units on a scale | Standard Deviation 1.59 |
| Tanezumab 2.5/5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Baseline | 1.80 units on a scale | Standard Deviation 4.5 |
| Tanezumab 2.5/5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 8 | -0.16 units on a scale | Standard Deviation 1.73 |
| Tanezumab 2.5/5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 24 | -0.29 units on a scale | Standard Deviation 2.6 |
| Tanezumab 2.5/5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 16 | -0.35 units on a scale | Standard Deviation 2.72 |
| Tanezumab 2.5/5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 12 | -0.28 units on a scale | Standard Deviation 2.24 |
| Tanezumab 2.5/5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40 | Change at Week 40 | -0.52 units on a scale | Standard Deviation 2.55 |
Secondary
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24
PGA of osteoarthritis 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 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 | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24 | Baseline | 3.46 units on a scale | Standard Deviation 0.57 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24 | Change at Week 24 | -0.87 units on a scale | Standard Deviation 0.85 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24 | Baseline | 3.42 units on a scale | Standard Deviation 0.6 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24 | Change at Week 24 | -0.72 units on a scale | Standard Deviation 0.93 |
| Tanezumab 2.5/5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24 | Baseline | 3.53 units on a scale | Standard Deviation 0.62 |
| Tanezumab 2.5/5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24 | Change at Week 24 | -0.91 units on a scale | Standard Deviation 1.03 |
Secondary
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12
PGA of osteoarthritis 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 and 12
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 and 12 | Change at Week 2 | -0.74 units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 4 | -0.75 units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 8 | -0.82 units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 12 | -0.83 units on a scale | Standard Error 0.08 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 12 | -1.01 units on a scale | Standard Error 0.08 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 2 | -0.91 units on a scale | Standard Error 0.07 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 8 | -0.97 units on a scale | Standard Error 0.07 |
| Tanezumab 2.5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 4 | -1.01 units on a scale | Standard Error 0.07 |
| Tanezumab 2.5/5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 12 | -1.11 units on a scale | Standard Error 0.08 |
| Tanezumab 2.5/5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 4 | -0.97 units on a scale | Standard Error 0.07 |
| Tanezumab 2.5/5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 8 | -0.91 units on a scale | Standard Error 0.07 |
| Tanezumab 2.5/5 mg | Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12 | Change at Week 2 | -0.87 units on a scale | Standard Error 0.07 |
Comparison: Week 2: 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 covariate, and study site as a random effect.p-value: 0.023695% CI: [-0.32, -0.02]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 included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis subscale and baseline diary average pain as covariate, and study site as a random effect.p-value: 0.095895% CI: [-0.27, 0.02]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 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 covariate, and study site as a random effect.p-value: 0.000795% CI: [-0.4, -0.11]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 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 covariate, and study site as a random effect.p-value: 0.00495% CI: [-0.36, -0.07]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 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 covariate, and study site as a random effect.p-value: 0.049895% CI: [-0.31, 0]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 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 covariate, and study site as a random effect.p-value: 0.23895% CI: [-0.24, 0.06]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 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 covariate, and study site as a random effect.p-value: 0.042695% CI: [-0.34, -0.01]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 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 covariate, and study site as a random effect.p-value: 0.001495% CI: [-0.45, -0.11]ANCOVA
Secondary
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40
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, Weeks 24 and 40
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 Weeks 24 and 40 | Number of symptoms reported: Baseline | 0.47 units on a scale | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Number of symptoms reported: Change at Week 24 | 0.42 units on a scale | Standard Deviation 1.33 |
| Placebo | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Number of symptoms reported: Change at Week 40 | 0.23 units on a scale | Standard Deviation 1.22 |
| Placebo | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Total Symptom Impact Score: Baseline | 1.07 units on a scale | Standard Deviation 1.72 |
| Placebo | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Total Symptom Impact Score: Change at Week 24 | 1.44 units on a scale | Standard Deviation 3.82 |
| Placebo | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Total Symptom Impact Score: Change at Week 40 | 0.83 units on a scale | Standard Deviation 3.43 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Total Symptom Impact Score: Change at Week 40 | 0.89 units on a scale | Standard Deviation 3.79 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Number of symptoms reported: Baseline | 0.54 units on a scale | Standard Deviation 0.82 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Total Symptom Impact Score: Baseline | 1.15 units on a scale | Standard Deviation 1.71 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Total Symptom Impact Score: Change at Week 24 | 1.22 units on a scale | Standard Deviation 3.66 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Number of symptoms reported: Change at Week 24 | 0.30 units on a scale | Standard Deviation 1.25 |
| Tanezumab 2.5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Number of symptoms reported: Change at Week 40 | 0.18 units on a scale | Standard Deviation 1.27 |
| Tanezumab 2.5/5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Number of symptoms reported: Change at Week 24 | 0.38 units on a scale | Standard Deviation 1.26 |
| Tanezumab 2.5/5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Number of symptoms reported: Change at Week 40 | 0.26 units on a scale | Standard Deviation 1.28 |
| Tanezumab 2.5/5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Total Symptom Impact Score: Change at Week 40 | 0.96 units on a scale | Standard Deviation 3.46 |
| Tanezumab 2.5/5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Total Symptom Impact Score: Baseline | 1.00 units on a scale | Standard Deviation 1.73 |
| Tanezumab 2.5/5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Number of symptoms reported: Baseline | 0.45 units on a scale | Standard Deviation 0.73 |
| Tanezumab 2.5/5 mg | Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40 | Total Symptom Impact Score: Change at Week 24 | 1.22 units on a scale | Standard Deviation 3.48 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score 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 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 \[minimum difficulty\] 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 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 | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 24 | Baseline | 7.39 units on a scale | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 24 | Change at Week 24 | -2.96 units on a scale | Standard Deviation 2.37 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 24 | Baseline | 7.18 units on a scale | Standard Deviation 1.11 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 24 | Change at Week 24 | -2.80 units on a scale | Standard Deviation 2.48 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 24 | Baseline | 7.44 units on a scale | Standard Deviation 1.17 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 24 | Change at Week 24 | -2.94 units on a scale | Standard Deviation 2.41 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score 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 osteoarthritis 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 \[minimum difficulty\] 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 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) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -2.70 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -2.49 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -2.07 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -2.24 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -2.53 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -3.17 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -2.88 units on a scale | Standard Error 0.2 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -3.28 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -3.59 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -3.22 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -3.39 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -3.74 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -2.95 units on a scale | Standard Error 0.2 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -3.08 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -3.31 units on a scale | Standard Error 0.21 |
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 score and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.22, -0.41]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 score and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.29, -0.48]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 score and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.46, -0.63]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 score and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.49, -0.66]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 score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.002495% CI: [-1.12, -0.24]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 score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.007895% CI: [-1.03, -0.16]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 score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000295% CI: [-1.35, -0.43]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 score and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.5, -0.57]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 score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.003495% CI: [-1.16, -0.23]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 score and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.000395% CI: [-1.33, -0.4]ANCOVA
Secondary
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. 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 NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
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). 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 24 | Baseline | 7.30 units on a scale | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24 | -3.07 units on a scale | Standard Deviation 2.43 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline | 7.08 units on a scale | Standard Deviation 1.16 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24 | -2.80 units on a scale | Standard Deviation 2.5 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Baseline | 7.33 units on a scale | Standard Deviation 1.26 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 | Change at Week 24 | -2.95 units on a scale | Standard Deviation 2.49 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8 and 12
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 and 12 | Change at Week 8 | -2.61 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 2 | -2.20 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 12 | -2.83 units on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 4 | -2.40 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 8 | -3.20 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 4 | -3.28 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 12 | -3.61 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 2 | -2.87 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 12 | -3.69 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 2 | -2.89 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 4 | -3.27 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12 | Change at Week 8 | -3.02 units on a scale | Standard Error 0.21 |
Comparison: Week 2: 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 covariate, and study site as a random effect.p-value: 0.00295% CI: [-1.08, -0.24]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 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 covariate, and study site as a random effect.p-value: 0.001495% CI: [-1.1, -0.26]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 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 covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.31, -0.45]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 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 covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.3, -0.44]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 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 covariate, and study site as a random effect.p-value: 0.008595% CI: [-1.03, -0.15]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 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 covariate, and study site as a random effect.p-value: 0.065795% CI: [-0.85, 0.03]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 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 covariate, and study site as a random effect.p-value: 0.001295% CI: [-1.25, -0.31]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 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 covariate, and study site as a random effect.p-value: 0.000495% CI: [-1.33, -0.38]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 24
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis 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 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 | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 24 | Baseline | 7.22 units on a scale | Standard Deviation 1.39 |
| 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 24 | Change at Week 24 | -2.93 units on a scale | Standard Deviation 2.71 |
| 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 24 | Baseline | 7.03 units on a scale | Standard Deviation 1.4 |
| 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 24 | Change at Week 24 | -2.64 units on a scale | Standard Deviation 2.69 |
| Tanezumab 2.5/5 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 24 | Baseline | 7.24 units on a scale | Standard Deviation 1.42 |
| Tanezumab 2.5/5 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 24 | Change at Week 24 | -2.74 units on a scale | Standard Deviation 2.72 |
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 and 16
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis 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 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 Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -2.77 units on a scale | Standard Error 0.23 |
| 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 and 16 | Change at Week 8 | -2.55 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 2 | -2.09 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 4 | -2.31 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 16 | -2.57 units on a scale | Standard Error 0.23 |
| 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 and 16 | Change at Week 8 | -3.19 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 2 | -2.75 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 4 | -3.16 units on a scale | Standard Error 0.21 |
| 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 and 16 | Change at Week 12 | -3.53 units on a scale | Standard Error 0.23 |
| 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 and 16 | Change at Week 16 | -3.17 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5/5 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 and 16 | Change at Week 16 | -3.24 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5/5 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 and 16 | Change at Week 12 | -3.60 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5/5 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 and 16 | Change at Week 2 | -2.76 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 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 and 16 | Change at Week 8 | -2.89 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 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 and 16 | Change at Week 4 | -3.22 units on a scale | Standard Error 0.21 |
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: 0.002695% CI: [-1.1, -0.23]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: 0.002395% CI: [-1.1, -0.24]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: 0.000295% CI: [-1.29, -0.4]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: [-1.35, -0.47]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: 0.006695% CI: [-1.11, -0.18]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: 0.150695% CI: [-0.79, 0.12]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: 0.002195% CI: [-1.25, -0.28]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: 0.000895% CI: [-1.32, -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 pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.016795% CI: [-1.09, -0.11]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: 0.007395% CI: [-1.17, -0.18]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) 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 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 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 | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Week 24 | Baseline | 8.09 units on a scale | Standard Deviation 1.23 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Week 24 | Change at Week 24 | -3.12 units on a scale | Standard Deviation 2.62 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Week 24 | Baseline | 7.91 units on a scale | Standard Deviation 1.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Week 24 | Change at Week 24 | -2.76 units on a scale | Standard Deviation 2.52 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Week 24 | Baseline | 8.13 units on a scale | Standard Deviation 1.24 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Week 24 | Change at Week 24 | -2.86 units on a scale | Standard Deviation 2.65 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) 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 osteoarthritis 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 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 (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -2.97 units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -2.77 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -2.24 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -2.53 units on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -2.70 units on a scale | Standard Error 0.24 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -3.40 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -2.88 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -3.50 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -3.82 units on a scale | Standard Error 0.24 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -3.40 units on a scale | Standard Error 0.24 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -3.59 units on a scale | Standard Error 0.24 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -3.94 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -3.10 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -3.21 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -3.63 units on a scale | Standard Error 0.22 |
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: 0.005895% CI: [-1.09, -0.18]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: [-1.31, -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 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: [-1.44, -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 going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.56, -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 WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.009195% CI: [-1.11, -0.16]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: 0.066895% CI: [-0.92, 0.03]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: 0.001195% CI: [-1.36, -0.34]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: 0.000295% CI: [-1.48, -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 WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.005995% CI: [-1.2, -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 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: [-1.39, -0.39]ANCOVA
Secondary
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 osteoarthritis. 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 osteoarthritis 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 of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated maximum 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). 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 24 | Baseline | 7.38 units on a scale | Standard Deviation 1.12 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24 | -3.03 units on a scale | Standard Deviation 2.37 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline | 7.18 units on a scale | Standard Deviation 1.11 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24 | -2.85 units on a scale | Standard Deviation 2.51 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Baseline | 7.39 units on a scale | Standard Deviation 1.18 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 | Change at Week 24 | -3.01 units on a scale | Standard Deviation 2.46 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 osteoarthritis 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 of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Time frame: Baseline, Weeks 2, 4, 8 and 12
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 and 12 | Change at Week 2 | -2.14 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 4 | -2.28 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 8 | -2.55 units on a scale | Standard Error 0.21 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 12 | -2.75 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 12 | -3.61 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 2 | -2.89 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 8 | -3.17 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 4 | -3.30 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 12 | -3.80 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 4 | -3.38 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 8 | -3.12 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12 | Change at Week 2 | -3.05 units on a scale | Standard Error 0.21 |
Comparison: Week 2: 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 covariate, and study site as a random effect.p-value: 0.000495% CI: [-1.17, -0.34]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 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 covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.33, -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 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 covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.45, -0.6]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 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 covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.53, -0.68]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 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 covariate, and study site as a random effect.p-value: 0.005795% CI: [-1.07, -0.18]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 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 covariate, and study site as a random effect.p-value: 0.011495% CI: [-1.02, -0.13]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 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 covariate, and study site as a random effect.p-value: 0.000495% CI: [-1.33, -0.38]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 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 covariate, and study site as a random effect.p-value: <0.000195% CI: [-1.52, -0.58]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness 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. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
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). 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) Stiffness Subscale at Week 24 | Baseline | 7.49 units on a scale | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24 | -2.77 units on a scale | Standard Deviation 2.66 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline | 7.27 units on a scale | Standard Deviation 1.4 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24 | -2.74 units on a scale | Standard Deviation 2.7 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Baseline | 7.58 units on a scale | Standard Deviation 1.4 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 | Change at Week 24 | -2.86 units on a scale | Standard Deviation 2.6 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness 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 osteoarthritis. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
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) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -2.55 units on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -2.34 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -1.85 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -2.04 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -2.38 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -3.13 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -2.90 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -3.28 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -3.59 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -3.22 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 16 | -3.37 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 12 | -3.75 units on a scale | Standard Error 0.23 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 2 | -2.90 units on a scale | Standard Error 0.21 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 8 | -3.08 units on a scale | Standard Error 0.22 |
| Tanezumab 2.5/5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16 | Change at Week 4 | -3.27 units on a scale | Standard Error 0.22 |
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: [-1.47, -0.61]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: [-1.47, -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 WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.67, -0.81]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: [-1.66, -0.8]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: 0.000795% CI: [-1.25, -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 stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: 0.001395% CI: [-1.2, -0.29]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: [-1.51, -0.55]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: [-1.67, -0.73]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: 0.000795% CI: [-1.32, -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 stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.p-value: <0.000195% CI: [-1.48, -0.51]ANCOVA
Secondary
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16
WPAI is 6-question participant rated questionnaire to determine the impact of osteoarthritis 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 and Week 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). 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) Scores at Week 16 | Change at Week 16: Percent Work Time Missed | -3.58 units on a scale | Standard Error 1.27 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16:Percent Impairment While Working | -21.89 units on a scale | Standard Error 3.46 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16: Percent Overall Work Impairment | -22.48 units on a scale | Standard Error 3.52 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16: Percent Activity Impairment | -26.72 units on a scale | Standard Error 2.18 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16: Percent Activity Impairment | -30.55 units on a scale | Standard Error 2.16 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16: Percent Work Time Missed | -2.97 units on a scale | Standard Error 1.17 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16: Percent Overall Work Impairment | -28.28 units on a scale | Standard Error 3.29 |
| Tanezumab 2.5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16:Percent Impairment While Working | -27.32 units on a scale | Standard Error 3.24 |
| Tanezumab 2.5/5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16: Percent Activity Impairment | -30.49 units on a scale | Standard Error 2.14 |
| Tanezumab 2.5/5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16:Percent Impairment While Working | -27.48 units on a scale | Standard Error 3.39 |
| Tanezumab 2.5/5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16: Percent Overall Work Impairment | -28.87 units on a scale | Standard Error 3.44 |
| Tanezumab 2.5/5 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16 | Change at Week 16: Percent Work Time Missed | -5.26 units on a scale | Standard Error 1.23 |
Comparison: 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: 0.698495% CI: [-2.48, 3.7]ANCOVA
Comparison: 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: 0.295395% CI: [-4.84, 1.48]ANCOVA
Comparison: 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: 0.191195% CI: [-13.59, 2.74]ANCOVA
Comparison: 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: 0.185795% CI: [-13.89, 2.71]ANCOVA
Comparison: 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: 0.170795% CI: [-14.12, 2.52]ANCOVA
Comparison: 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: 0.13895% CI: [-14.85, 2.07]ANCOVA
Comparison: 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: 0.115195% CI: [-8.58, 0.94]ANCOVA
Comparison: 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: 0.119595% CI: [-8.51, 0.98]ANCOVA
Secondary
European Quality of Life-5 Dimensions-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 patient 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 patient reports greater levels of problems across the five dimensions.
Time frame: Baseline, Weeks 8 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). Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Mobility | 2.2 units on a scale | Standard Deviation 0.89 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Mobility | 2.3 units on a scale | Standard Deviation 0.84 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Pain/Discomfort | 2.4 units on a scale | Standard Deviation 0.87 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.67 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Self-care | 1.6 units on a scale | Standard Deviation 0.78 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 2.9 units on a scale | Standard Deviation 0.74 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Pain/Discomfort | 2.6 units on a scale | Standard Deviation 0.78 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Usual activities | 2.2 units on a scale | Standard Deviation 0.85 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.66 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Usual activities | 2.1 units on a scale | Standard Deviation 0.91 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Pain/Discomfort | 3.3 units on a scale | Standard Deviation 0.73 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Self-care | 2.2 units on a scale | Standard Deviation 0.9 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Self-care | 1.6 units on a scale | Standard Deviation 0.77 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Anxiety/Depression | 1.5 units on a scale | Standard Deviation 0.77 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Mobility | 3.0 units on a scale | Standard Deviation 0.71 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Self-care | 1.6 units on a scale | Standard Deviation 0.78 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Mobility | 3.0 units on a scale | Standard Deviation 0.68 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Self-care | 2.3 units on a scale | Standard Deviation 0.9 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 3.0 units on a scale | Standard Deviation 0.72 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Pain/Discomfort | 3.4 units on a scale | Standard Deviation 0.68 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Anxiety/Depression | 1.5 units on a scale | Standard Deviation 0.77 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Mobility | 2.1 units on a scale | Standard Deviation 0.86 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Self-care | 1.5 units on a scale | Standard Deviation 0.76 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Usual activities | 2.1 units on a scale | Standard Deviation 0.84 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Anxiety/Depression | 1.3 units on a scale | Standard Deviation 0.56 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Mobility | 2.1 units on a scale | Standard Deviation 0.85 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Pain/Discomfort | 2.4 units on a scale | Standard Deviation 0.8 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Usual activities | 2.0 units on a scale | Standard Deviation 0.86 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Pain/Discomfort | 2.3 units on a scale | Standard Deviation 0.81 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Anxiety/Depression | 1.3 units on a scale | Standard Deviation 0.62 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Anxiety/Depression | 1.6 units on a scale | Standard Deviation 0.87 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Anxiety/Depression | 1.3 units on a scale | Standard Deviation 0.64 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Mobility | 2.0 units on a scale | Standard Deviation 0.89 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Pain/Discomfort | 3.4 units on a scale | Standard Deviation 0.73 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Pain/Discomfort | 2.3 units on a scale | Standard Deviation 0.92 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Self-care | 1.5 units on a scale | Standard Deviation 0.7 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Usual activities | 3.0 units on a scale | Standard Deviation 0.73 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Mobility | 3.0 units on a scale | Standard Deviation 0.63 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 16: Usual activities | 2.0 units on a scale | Standard Deviation 0.88 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Usual activities | 2.1 units on a scale | Standard Deviation 0.83 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Self-care | 1.6 units on a scale | Standard Deviation 0.79 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Pain/Discomfort | 2.4 units on a scale | Standard Deviation 0.85 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Mobility | 2.2 units on a scale | Standard Deviation 0.84 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Baseline: Self-care | 2.3 units on a scale | Standard Deviation 0.88 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score | Week 8: Anxiety/Depression | 1.4 units on a scale | Standard Deviation 0.65 |
Secondary
European Quality of Life-5 Dimensions-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 \<=1. The Overall health utility score for a patient 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 patient reports greater levels of problems across the five dimensions.
Time frame: Baseline, Weeks 8 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). 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 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 8 | 0.75 units on a scale | Standard Deviation 0.12 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Baseline | 0.63 units on a scale | Standard Deviation 0.14 |
| Placebo | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 16 | 0.76 units on a scale | Standard Deviation 0.13 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 8 | 0.77 units on a scale | Standard Deviation 0.12 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Baseline | 0.63 units on a scale | Standard Deviation 0.13 |
| Tanezumab 2.5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 16 | 0.77 units on a scale | Standard Deviation 0.13 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Baseline | 0.61 units on a scale | Standard Deviation 0.14 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 16 | 0.78 units on a scale | Standard Deviation 0.14 |
| Tanezumab 2.5/5 mg | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value | Week 8 | 0.76 units on a scale | Standard Deviation 0.13 |
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 24 and Week 40. Domain evaluated was duration since quitting job due to OA.
Time frame: Baseline, Weeks 24 and 40
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 24 | 0.9 years |
| Placebo | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline | 4.3 years |
| Placebo | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 40 | 1.1 years |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 24 | 5.0 years |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline | 2.2 years |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 40 | 3.3 years |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Baseline | 4.3 years |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 40 | 2.5 years |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis | Week 24 | 1.3 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 40) and past 8 weeks (for Week 24). Domain evaluated was number of nights stayed in the hospital due to OA.
Time frame: Baseline, Weeks 24 and 40
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 | Week 24 | 3.0 nights |
| Placebo | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 40 | 3.5 nights |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 24 | 2.0 nights |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Week 40 | 1.5 nights |
| Unknown | Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis | Baseline | — 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 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who were hospitalized due to OA.
Time frame: Baseline, Weeks 24 and 40
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 24 | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 40 | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 24 | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 40 | 0 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Baseline | 0 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 40 | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis | Week 24 | 2 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 24 and Week 40. Domain evaluated was number of participants who quit job due to OA.
Time frame: Baseline, Weeks 24 and 40
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 | Baseline | 7 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 24 | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 40 | 4 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 40 | 6 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 24 | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Baseline | 9 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Baseline | 11 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 24 | 5 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis | Week 40 | 8 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 40) and past 8 weeks (for Week 24). 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 24 and 40
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 40 :Wheelchair Use:Never | Rarely | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Rarely | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Always | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Never | 183 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Sometimes | 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 | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Always | 4 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Wheelchair Use | Never | 229 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Often | 3 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Always | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Often | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Sometimes | 13 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Never | 195 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 | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Rarely | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Rarely | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking Aid Use | Often | 11 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Never | 164 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Sometimes | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Sometimes | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Always | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Often | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other Aids Or Devices:Never | Never | 217 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Often | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Always | 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 24:Other Aids Or Devices:Never | Sometimes | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Never | 189 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Rarely | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Rarely | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other Aids Or Devices:Never | Rarely | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Wheelchair Use | Sometimes | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Never | 180 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other Aids Or Devices:Never | Sometimes | 4 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking Aid Use | Sometimes | 18 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40: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 | Baseline:Other Aids Or Devices:Never | Often | 5 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 | 228 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40: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 | Baseline:Other Aids Or Devices:Never | Always | 5 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Wheelchair Use | Rarely | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40: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 24 :Walking Aid Use:Never | Never | 168 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking Aid Use | Rarely | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40: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 24 :Walking Aid Use:Never | Rarely | 6 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 40:Device/Utensil to Dress Bathe Eat | Never | 183 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Sometimes | 11 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking Aid Use | Always | 5 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Always | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Often | 4 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking Aid Use | Never | 196 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Often | 1 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Always | 7 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 | 2 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Sometimes | 0 Participants |
| Placebo | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Never | 195 Participants |
| Placebo | 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 | Never | 230 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 | 1 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 | 221 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 | 1 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 | 7 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 | 0 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 | Never | 211 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 | Rarely | 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 | Sometimes | 7 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 | 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:Never | Always | 4 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Never | 185 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Rarely | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Sometimes | 6 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Often | 4 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Always | 5 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Never | 200 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Rarely | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Sometimes | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Often | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Always | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Never | 200 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-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 24:Device/Utensil-Dress Bathe Eat | Sometimes | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-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 24:Device/Utensil-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 24:Other Aids Or Devices:Never | Never | 197 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Sometimes | 3 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Often | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Always | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Never | 175 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Rarely | 5 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Sometimes | 5 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Often | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Always | 7 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Never | 194 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Sometimes | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Often | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Always | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Device/Utensil to Dress Bathe Eat | Never | 191 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40: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 40:Device/Utensil to Dress Bathe Eat | Sometimes | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Device/Utensil to Dress Bathe Eat | Often | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40: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 40:Other Aids Or Devices:Never | Never | 187 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Rarely | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Sometimes | 1 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Often | 4 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Always | 2 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 | 187 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 | 5 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 | 23 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 | 10 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 | 6 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Never | 189 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Never | 204 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking Aid Use | Often | 13 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Rarely | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Always | 7 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Always | 0 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Sometimes | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Often | 5 Participants |
| Tanezumab 2.5/5 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 | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Often | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Sometimes | 10 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Wheelchair Use | Sometimes | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Wheelchair Use:Never | Always | 0 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Rarely | 9 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking Aid Use | Never | 189 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Device/Utensil to Dress Bathe Eat | Never | 188 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24 :Walking Aid Use:Never | Never | 175 Participants |
| Tanezumab 2.5/5 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 | 225 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Device/Utensil to Dress Bathe Eat | Rarely | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other Aids Or Devices:Never | Always | 4 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Wheelchair Use | Never | 230 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Device/Utensil to Dress Bathe Eat | Sometimes | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other Aids Or Devices:Never | Often | 6 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking Aid Use | Rarely | 10 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Device/Utensil to Dress Bathe Eat | Often | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other Aids Or Devices:Never | Sometimes | 14 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Wheelchair Use | Always | 0 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Device/Utensil to Dress Bathe Eat | Always | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other Aids Or Devices:Never | Rarely | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Walking Aid Use | Always | 6 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Never | 187 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Never | 199 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Other Aids Or Devices:Never | Never | 208 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Rarely | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Always | 1 Participants |
| Tanezumab 2.5/5 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 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Sometimes | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Often | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Rarely | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Often | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Sometimes | 0 Participants |
| Tanezumab 2.5/5 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 | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Other Aids Or Devices:Never | Always | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Rarely | 0 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Wheelchair Use | Often | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Never | 170 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Device/Utensil-Dress Bathe Eat | Never | 203 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Sometimes | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Rarely | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Always | 0 Participants |
| Tanezumab 2.5/5 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 | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Sometimes | 7 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Often | 0 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Baseline:Wheelchair Use | Rarely | 0 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Often | 6 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Sometimes | 2 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40:Other Aids Or Devices:Never | Often | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 40 :Walking Aid Use:Never | Always | 7 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things | Week 24:Wheelchair Use:Never | Rarely | 0 Participants |
| Tanezumab 2.5/5 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 | 4 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 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who visited the emergency room due to osteoarthritis (OA).
Time frame: Baseline, Weeks 24 and 40
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 24 | 0 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 40 | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 24 | 0 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Baseline | 2 Participants |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 40 | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Baseline | 4 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 40 | 1 Participants |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis | Week 24 | 2 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 40) and past 8 weeks (for Week 24). 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 24 and 40
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 40: Home Healthcare Services | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Other Practitioner | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24:Primary Care Physician | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Alternative Medicine Or Therapy | 3.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Radiologist | 1.5 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Orthopedist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Rheumatologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Rheumatologist | 1.5 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Nutritionist/Dietitian | 2.5 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Physician Assistant Or Nurse Practitioner | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Podiatrist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Pain Specialist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Chiropractor | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Alternative Medicine Or Therapy | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Orthopedist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Physical therapist | 3.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Chiropractor | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Physical Therapist | 2.5 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 40: Physical Therapist | 8.0 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 | Week 40: Radiologist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Orthopedist | 1.5 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Alternative medicine or therapy | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Physician assistant or nurse practitioner | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Pain Specialist | 1.5 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 | Baseline:Primary Care Physician | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Physician Assistant Or Nurse Practitioner | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Nutritionist/Dietitian | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Other Practitioner | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Rheumatologist | 1.0 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 | Week 40: Podiatrist | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Neurologist | 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 | Baseline:Pain specialist | 2.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Primary Care Physician | 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 | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Neurologist | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Rheumatologist | 1.0 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 | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Pain specialist | 3.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Orthopedist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Physical therapist | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Chiropractor | 3.0 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 | 2.0 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 24: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 24: Neurologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Rheumatologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Pain Specialist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Orthopedist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Physical Therapist | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Chiropractor | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Alternative Medicine Or Therapy | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Podiatrist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Nutritionist/Dietitian | 1.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Radiologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Other Practitioner | 2.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: 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 40: Neurologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Rheumatologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Physician Assistant Or Nurse Practitioner | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Pain Specialist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Orthopedist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Physical Therapist | 6.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Chiropractor | 3.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Alternative Medicine Or Therapy | 1.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Podiatrist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Nutritionist/Dietitian | 3.5 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Radiologist | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Home Healthcare Services | 30.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Other Practitioner | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Physician assistant or nurse practitioner | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Primary Care Physician | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Radiologist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Other Practitioner | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Neurologist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Nutritionist/Dietitian | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Podiatrist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Rheumatologist | 2.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Podiatrist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Home Healthcare Services | 7.5 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Physician Assistant Or Nurse Practitioner | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Alternative medicine or therapy | 2.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Nutritionist/Dietitian | 1.5 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Pain Specialist | 2.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Chiropractor | 4.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Rheumatologist | 1.5 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Orthopedist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Physical therapist | 3.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Primary Care Physician | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Physical Therapist | 4.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Physical Therapist | 8.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Orthopedist | 2.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Orthopedist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Chiropractor | 2.5 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Pain Specialist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Radiologist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Alternative Medicine Or Therapy | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Physician Assistant Or Nurse Practitioner | 2.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Chiropractor | 5.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Podiatrist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Rheumatologist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Pain specialist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Nutritionist/Dietitian | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24:Primary Care Physician | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Neurologist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Radiologist | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline: Other Practitioner | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 40: Alternative Medicine Or Therapy | 2.5 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Week 24: Other Practitioner | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis | Baseline:Home healthcare services | 2.0 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 40) and past 8 weeks (for Week 24). Domain evaluated was number of visits to the emergency room due to OA.
Time frame: Baseline, Weeks 24 and 40
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 40 | 1.0 visits |
| Placebo | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline | 1.0 visits |
| Tanezumab 2.5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 40 | 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 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 24 | 2.5 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Baseline | 1.0 visits |
| Tanezumab 2.5/5 mg | Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis | Week 40 | 1.0 visits |
Secondary
Number of Days of Rescue Medication Use at Week 24
In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 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 the particular study week were summarized.
Time frame: 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 took rescue medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Days of Rescue Medication Use at Week 24 | 1.3 days | Standard Deviation 1.75 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Use at Week 24 | 2.0 days | Standard Deviation 2.24 |
| Tanezumab 2.5/5 mg | Number of Days of Rescue Medication Use at Week 24 | 1.8 days | Standard Deviation 2.18 |
Secondary
Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16
In case of inadequate pain relief during the treatment period, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.
Time frame: Week 2, 4, 8, 12, 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 | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 16 | 1.48 days | Standard Error 0.22 |
| Placebo | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 8 | 1.77 days | Standard Error 0.21 |
| Placebo | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 4 | 2.20 days | Standard Error 0.25 |
| Placebo | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 12 | 1.45 days | Standard Error 0.21 |
| Placebo | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 2 | 2.46 days | Standard Error 0.24 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 12 | 1.31 days | Standard Error 0.18 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 16 | 1.57 days | Standard Error 0.21 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 2 | 2.27 days | Standard Error 0.22 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 4 | 1.93 days | Standard Error 0.22 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 8 | 1.68 days | Standard Error 0.2 |
| Tanezumab 2.5/5 mg | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 2 | 2.02 days | Standard Error 0.19 |
| Tanezumab 2.5/5 mg | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 12 | 1.12 days | Standard Error 0.16 |
| Tanezumab 2.5/5 mg | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 8 | 1.53 days | Standard Error 0.18 |
| Tanezumab 2.5/5 mg | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 16 | 1.39 days | Standard Error 0.19 |
| Tanezumab 2.5/5 mg | Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16 | Week 4 | 1.68 days | Standard Error 0.19 |
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: 0.483395% CI: [0.73, 1.16]Negative binomial model
p-value: 0.094295% CI: [0.65, 1.03]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: 0.337195% CI: [0.67, 1.15]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: 0.050895% CI: [0.58, 1]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: 0.72895% CI: [0.71, 1.27]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: 0.324495% CI: [0.65, 1.15]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: 0.568195% CI: [0.65, 1.27]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: 0.138795% CI: [0.55, 1.09]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: 0.727595% CI: [0.76, 1.48]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: 0.70995% CI: [0.67, 1.31]Negative binomial model
Secondary
Number of Participants Who Took Rescue Medication During Week 24
In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 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 participants with any use of rescue medication during the 4 weeks up to the particular study week were summarized.
Time frame: 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 took rescue medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Took Rescue Medication During Week 24 | 108 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Week 24 | 125 Participants |
| Tanezumab 2.5/5 mg | Number of Participants Who Took Rescue Medication During Week 24 | 118 Participants |
Secondary
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16
In case of inadequate pain relief, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 16. Number of participants with any use of rescue medication during the particular study week were summarized.
Time frame: Week 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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 12 | 103 Participants |
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 8 | 117 Participants |
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 2 | 160 Participants |
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 4 | 143 Participants |
| Placebo | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 16 | 100 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 8 | 110 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 2 | 137 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 4 | 119 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 12 | 93 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 16 | 101 Participants |
| Tanezumab 2.5/5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 16 | 96 Participants |
| Tanezumab 2.5/5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 12 | 88 Participants |
| Tanezumab 2.5/5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 2 | 138 Participants |
| Tanezumab 2.5/5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 8 | 117 Participants |
| Tanezumab 2.5/5 mg | Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16 | Week 4 | 110 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: 0.076195% CI: [0.48, 1.04]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: 0.031295% CI: [0.44, 0.96]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: 0.026295% CI: [0.45, 0.95]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: 0.001395% CI: [0.37, 0.79]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: 0.670695% CI: [0.64, 1.33]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: 0.97295% CI: [0.69, 1.43]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: 0.531195% CI: [0.61, 1.29]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: 0.171295% CI: [0.53, 1.12]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: 0.747595% CI: [0.73, 1.54]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: 0.656495% CI: [0.63, 1.33]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 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 | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Withdrew Due to Lack of Efficacy | 13 Participants |
| Tanezumab 2.5 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 6 Participants |
| Tanezumab 2.5/5 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 4 Participants |
Comparison: 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: 0.144495% CI: [0.18, 1.29]Regression, Logistic
Comparison: 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: 0.033595% CI: [0.09, 0.91]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 and 40
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 | 15 Participants |
| Placebo | Number of Participants With Anti-Tanezumab Antibodies | Week 16 | 16 Participants |
| Placebo | Number of Participants With Anti-Tanezumab Antibodies | Baseline | 25 Participants |
| Placebo | Number of Participants With Anti-Tanezumab Antibodies | Week 8 | 22 Participants |
| Placebo | Number of Participants With Anti-Tanezumab Antibodies | Week 40 | 18 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 16 | 35 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Baseline | 25 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 8 | 29 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 24 | 30 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 40 | 29 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 40 | 33 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 24 | 40 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Anti-Tanezumab Antibodies | Baseline | 23 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 16 | 43 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Anti-Tanezumab Antibodies | Week 8 | 36 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 up to Week 40
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 | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Confirmed Orthostatic Hypotension | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Confirmed Orthostatic Hypotension | 3 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Confirmed Orthostatic Hypotension | 1 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; 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; Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN; Urine erythrocytes \>=20.
Time frame: Baseline up to Week 40
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 | 14 Participants |
| Tanezumab 2.5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 10 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline | 3 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
Primary Abnormality criteria: hemoglobin; hematocrit; RBC count \[less than{\<}0.8\* lower limit of normal\[LLN\]; 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; 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;Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN, specific gravity \<1.003, \>1.030; pH\<4.5, \>8; Urine Leukocytes \>=20.
Time frame: Baseline up to Week 40
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 Normal Baseline | 20 Participants |
| Tanezumab 2.5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 12 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline | 11 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 40 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 40
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) | AEs | 145 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 9 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 156 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 7 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 143 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 11 Participants |
Secondary
Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
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 40 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 40
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) | AEs | 31 Participants |
| Placebo | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 40 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Tanezumab 2.5/5 mg | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 33 Participants |
Secondary
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis
PGA of osteoarthritis 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 osteoarthritis were reported. Missing data was imputed using mixed BOCF/LOCF.
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 (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 2 | 19.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 20.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 8 | 24.6 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 26.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 22.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 24 | 21.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 24 | 21.0 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 | 25.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 34.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 30.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 27.7 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 | 26.8 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 4 | 27.5 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 8 | 27.9 percentage of participants |
| Tanezumab 2.5/5 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 2.5/5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 12 | 39.1 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 2 | 22.3 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis | Week 16 | 31.3 percentage of participants |
Comparison: Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.146395% CI: [0.88, 2.34]Regression, Logistic
Comparison: Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.964495% CI: [0.6, 1.62]Regression, Logistic
Comparison: Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.042295% CI: [1.02, 2.59]Regression, Logistic
Comparison: Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.199595% CI: [0.85, 2.16]Regression, Logistic
Comparison: Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.487895% CI: [0.75, 1.84]Regression, Logistic
Comparison: Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.785695% CI: [0.68, 1.67]Regression, Logistic
Comparison: Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.047695% CI: [1, 2.39]Regression, Logistic
Comparison: Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.012495% CI: [1.12, 2.63]Regression, Logistic
Comparison: Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.030795% CI: [1.05, 2.62]Regression, Logistic
Comparison: Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.p-value: 0.084695% CI: [0.95, 2.35]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 and 24 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 osteoarthritis. 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) of 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 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 (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 4: At least 70% reduction | 16.4 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 2: 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 | 15.5 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 | 6.9 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 4: At least 30% reduction | 47.0 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 4: At least 50% reduction | 30.2 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 2: At least 30% reduction | 38.8 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 | 8.2 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 30% reduction | 49.1 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 50% reduction | 30.2 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 | 17.2 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 90% reduction | 9.1 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 12: At least 30% reduction | 54.3 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 | 40.5 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 12: At least 70% reduction | 24.1 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 12: At least 90% reduction | 9.9 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 16: At least 30% reduction | 54.7 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 16: At least 50% reduction | 37.9 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 16: At least 70% reduction | 25.0 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 16: At least 90% reduction | 9.5 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 24: At least 30% reduction | 60.5 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 24: At least 50% reduction | 39.5 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 24: At least 70% reduction | 23.2 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 24: At least 90% 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 24: At least 50% reduction | 40.0 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 2: At least 30% reduction | 56.3 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 | 70.1 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 30% reduction | 68.0 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 2: At least 50% reduction | 38.5 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 8: At least 70% reduction | 30.3 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 30% reduction | 60.5 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 2: At least 70% reduction | 25.5 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 12: At least 50% reduction | 60.2 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 24: At least 70% reduction | 21.0 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 2: At least 90% reduction | 13.4 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 8: At least 50% reduction | 47.2 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 16: At least 50% reduction | 54.5 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 | 65.4 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 12: At least 70% reduction | 39.8 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 8: At least 90% reduction | 13.0 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 50% reduction | 48.5 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 8: At least 30% reduction | 61.9 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 24: At least 90% reduction | 10.5 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 70% reduction | 29.4 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 12: At least 90% reduction | 18.6 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 | 34.6 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 4: At least 90% reduction | 16.0 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 16: At least 90% reduction | 14.7 percentage of participants |
| Tanezumab 2.5/5 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 | 15.5 percentage of participants |
| Tanezumab 2.5/5 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 | 61.4 percentage of participants |
| Tanezumab 2.5/5 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 | 42.5 percentage of participants |
| Tanezumab 2.5/5 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 | 25.8 percentage of participants |
| Tanezumab 2.5/5 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 | 14.2 percentage of participants |
| Tanezumab 2.5/5 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 | 12.9 percentage of participants |
| Tanezumab 2.5/5 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 2.5/5 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 | 75.1 percentage of participants |
| Tanezumab 2.5/5 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 | 56.2 percentage of participants |
| Tanezumab 2.5/5 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 | 59.9 percentage of participants |
| Tanezumab 2.5/5 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 | 39.5 percentage of participants |
| Tanezumab 2.5/5 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 | 8.9 percentage of participants |
| Tanezumab 2.5/5 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 | 18.9 percentage of participants |
| Tanezumab 2.5/5 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 | 56.2 percentage of participants |
| Tanezumab 2.5/5 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 | 38.2 percentage of participants |
| Tanezumab 2.5/5 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 | 70.4 percentage of participants |
| Tanezumab 2.5/5 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 | 24.5 percentage of participants |
| Tanezumab 2.5/5 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 | 41.6 percentage of participants |
| Tanezumab 2.5/5 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 | 9.4 percentage of participants |
| Tanezumab 2.5/5 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 | 63.5 percentage of participants |
| Tanezumab 2.5/5 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 | 57.1 percentage of participants |
| Tanezumab 2.5/5 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 | 48.5 percentage of participants |
| Tanezumab 2.5/5 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 | 29.6 percentage of participants |
| Tanezumab 2.5/5 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 | 36.5 percentage of participants |
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: 0.000995% CI: [1.3, 2.78]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: 0.000495% CI: [1.36, 2.9]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: 0.001595% CI: [1.29, 2.96]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, \>=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: 0.025195% CI: [1.07, 2.75]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: 0.027695% CI: [1.06, 2.72]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: 0.040495% CI: [1.03, 3.71]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: 0.348695% CI: [0.7, 2.72]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: 0.000295% CI: [1.42, 3.02]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: [1.32, 2.79]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: 0.000295% CI: [1.41, 3.05]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: [1.46, 3.15]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: 0.002495% CI: [1.28, 3.18]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: 0.001195% CI: [1.35, 3.34]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: 0.017295% CI: [1.14, 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: 0.017395% CI: [1.14, 3.72]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: 0.011895% CI: [1.11, 2.35]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: 0.013295% CI: [1.1, 2.32]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: 0.000595% CI: [1.35, 2.92]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: 0.0195% CI: [1.13, 2.45]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: 0.002395% CI: [1.28, 3.12]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: 0.032295% CI: [1.04, 2.58]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: 0.200595% CI: [0.81, 2.67]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: 0.192395% CI: [0.82, 2.68]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: 0.001395% CI: [1.28, 2.79]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: <0.000195% CI: [1.68, 3.73]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: [1.45, 3.1]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: 0.001495% CI: [1.26, 2.67]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: 0.000895% CI: [1.33, 2.99]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: 0.000595% CI: [1.37, 3.06]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: 0.012795% CI: [1.16, 3.49]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: 0.007595% CI: [1.22, 3.64]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: 0.006195% CI: [1.17, 2.52]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: 0.000795% CI: [1.33, 2.88]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: 0.00195% CI: [1.29, 2.76]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: 0.041195% CI: [1.02, 2.31]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: 0.00995% CI: [1.14, 2.57]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: 0.114995% CI: [0.89, 2.86]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: 0.135195% CI: [0.87, 2.79]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: <0.000195% CI: [1.48, 3.16]Regression, Logistic
Secondary
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=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 and 24 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 osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours,calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum 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 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 (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 70% reduction | 15.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 50% reduction | 23.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 70% reduction | 12.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 90% reduction | 5.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 30% reduction | 45.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 50% reduction | 26.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 30% reduction | 35.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 90% reduction | 6.9 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 30% reduction | 47.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 50% reduction | 28.9 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 70% reduction | 16.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 90% reduction | 7.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: 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 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 50% reduction | 37.9 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 70% reduction | 22.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 90% reduction | 9.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 30% reduction | 54.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 50% reduction | 36.6 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 70% reduction | 22.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 90% reduction | 10.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 30% reduction | 57.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 50% reduction | 38.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 70% reduction | 21.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 90% reduction | 8.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 50% reduction | 36.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 30% reduction | 55.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 30% reduction | 70.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 30% reduction | 65.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 50% reduction | 35.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 70% reduction | 27.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 30% reduction | 58.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 70% reduction | 26.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 50% reduction | 57.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 70% reduction | 22.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 90% reduction | 11.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 50% reduction | 47.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 50% reduction | 54.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 30% reduction | 66.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 70% reduction | 38.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 90% reduction | 13.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 50% reduction | 48.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 30% reduction | 58.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 90% reduction | 10.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 70% reduction | 30.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 90% reduction | 17.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 70% reduction | 34.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 90% reduction | 13.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 90% reduction | 14.3 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 90% reduction | 14.6 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 30% reduction | 61.8 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 50% reduction | 42.5 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 70% reduction | 27.9 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 90% reduction | 14.6 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 8: At least 90% reduction | 12.9 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 70% reduction | 20.8 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 30% reduction | 75.1 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 50% reduction | 56.2 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 30% reduction | 58.4 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 70% reduction | 39.5 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 90% reduction | 8.4 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 12: At least 90% reduction | 18.0 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 30% reduction | 56.7 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 50% reduction | 39.9 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 30% reduction | 71.7 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 70% reduction | 24.9 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 24: At least 50% reduction | 41.6 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 2: At least 90% reduction | 9.0 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 30% reduction | 64.4 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 50% reduction | 57.1 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 50% reduction | 48.5 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 4: At least 70% reduction | 30.5 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response | Week 16: At least 70% reduction | 36.1 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: 0.000195% CI: [1.45, 3.11]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: <0.000195% CI: [1.59, 3.4]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: [1.58, 3.36]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: 0.031295% CI: [1.04, 2.39]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: 0.000395% CI: [1.4, 3.19]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: 0.000595% CI: [1.48, 4.01]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: 0.000695% CI: [1.45, 3.94]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: 0.043695% CI: [1.02, 4.32]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: 0.134895% CI: [0.84, 3.69]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: [1.46, 3.09]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: [1.62, 3.57]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: [1.74, 3.82]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: 0.000395% CI: [1.47, 3.7]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: 0.000195% CI: [1.55, 3.89]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: 0.03195% CI: [1.07, 3.82]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: 0.008895% CI: [1.24, 4.34]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: 0.03695% CI: [1.03, 2.16]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: 0.003995% CI: [1.19, 2.51]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: 0.000295% CI: [1.43, 3.13]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: 0.00495% CI: [1.2, 2.62]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: 0.017595% CI: [1.1, 2.74]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: 0.006595% CI: [1.19, 2.94]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: 0.079695% CI: [0.94, 3.23]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: 0.071895% CI: [0.95, 3.27]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: 0.000495% CI: [1.36, 2.96]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: [1.78, 3.93]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: [1.44, 3.09]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: 0.000295% CI: [1.42, 3.04]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: 0.000395% CI: [1.41, 3.23]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: <0.000195% CI: [1.52, 3.46]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: 0.011395% CI: [1.18, 3.68]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: 0.006495% CI: [1.25, 3.85]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: 0.0295% CI: [1.07, 2.31]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: 0.000295% CI: [1.43, 3.14]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: 0.000595% CI: [1.34, 2.87]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: 0.014195% CI: [1.11, 2.56]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: 0.002295% CI: [1.26, 2.87]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: 0.228695% CI: [0.8, 2.5]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: 0.180895% CI: [0.84, 2.57]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: <0.000195% CI: [1.57, 3.36]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 greater or equal to (\>=) 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 osteoarthritis (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 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 (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 2 | 50.4 percentage of participants |
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 4 | 58.6 percentage of participants |
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 8 | 61.6 percentage of participants |
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 12 | 66.4 percentage of participants |
| Placebo | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 16 | 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 24 | 68.1 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 24 | 66.5 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 2 | 65.4 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 | 77.5 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 | 72.7 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 4 | 74.0 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 | 67.5 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 4 | 74.7 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 8 | 69.5 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 24 | 68.8 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 12 | 81.1 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 2 | 67.4 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | Week 16 | 79.0 percentage of participants |
Comparison: Week 2: Odds ratio and 95% 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: 0.002795% CI: [1.22, 2.61]Regression, Logistic
Comparison: Week 2: Odds ratio and 95% 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: 0.000495% CI: [1.36, 2.89]Regression, Logistic
Comparison: Week 4: Odds ratio and 95% 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: 0.000895% CI: [1.33, 2.95]Regression, Logistic
Comparison: Week 4: Odds ratio and 95% 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: 0.000495% CI: [1.37, 3.04]Regression, Logistic
Comparison: Week 8: Odds ratio and 95% 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: 0.228395% CI: [0.86, 1.87]Regression, Logistic
Comparison: Week 8: Odds ratio and 95% 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: 0.106695% CI: [0.93, 2.03]Regression, Logistic
Comparison: Week 12: Odds ratio and 95% 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: 0.015495% CI: [1.1, 2.54]Regression, Logistic
Comparison: Week 12: Odds ratio and 95% 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: 0.000695% CI: [1.38, 3.27]Regression, Logistic
Comparison: Week 16: Odds ratio and 95% 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: 0.113995% CI: [0.92, 2.07]Regression, Logistic
Comparison: Week 16: Odds ratio and 95% 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: 0.001495% CI: [1.31, 3.04]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 osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.
Time frame: Baseline up to Week 40
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 | 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 | Composite Joint Safety Endpoint | 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 | Pathological Fracture | 0 percentage of participants |
| Placebo | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 1 | 0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 2 | 0.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Composite Joint Safety Endpoint | 2.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA | 2.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 1 | 1.3 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 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Primary Osteonecrosis | 0 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA | 0.4 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Subchondral Insufficiency Fracture | 0 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Pathological Fracture | 0 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 2 | 0.0 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Rapidly Progressive OA type 1 | 0.4 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Adjudicated Joint Safety Outcomes | Composite Joint Safety Endpoint | 0.4 percentage of participants |
Secondary
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 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 Week 16 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Baseline to Week 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 (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=70% | 25.0 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=40% | 45.7 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=90% | 9.5 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=60% | 31.5 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=50% | 37.9 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=0% | 82.3 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=20% | 65.5 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=10% | 79.3 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=80% | 17.2 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=30% | 54.7 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | =100% | 3.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=50% | 54.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=0% | 87.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=10% | 81.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=20% | 74.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=30% | 68.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=40% | 63.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=60% | 44.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=70% | 34.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=80% | 24.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=90% | 14.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | =100% | 8.2 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=90% | 14.2 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=70% | 36.5 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=20% | 79.0 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=0% | 88.4 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=80% | 27.0 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=10% | 85.4 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=50% | 57.1 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=40% | 66.1 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | =100% | 10.7 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=60% | 44.6 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 | >=30% | 70.4 percentage of participants |
Secondary
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty),higher scores indicate extreme difficulty/worse physical function. 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 Week 16 were reported. Missing data was imputed using mixed BOCF/LOCF.
Time frame: Baseline to Week 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 (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=70% | 22.8 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=40% | 44.8 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=90% | 10.3 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=60% | 28.9 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=50% | 36.6 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=0% | 83.6 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=20% | 63.4 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=10% | 75.4 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=80% | 15.5 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=30% | 54.3 percentage of participants |
| Placebo | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | =100% | 2.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=50% | 54.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=0% | 89.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=10% | 81.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=20% | 72.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=30% | 65.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=40% | 60.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=60% | 45.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=70% | 34.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=80% | 24.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=90% | 14.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | =100% | 6.5 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=90% | 14.6 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=70% | 36.1 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=20% | 76.8 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=0% | 90.6 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=80% | 26.2 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=10% | 83.3 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=50% | 57.1 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=40% | 65.7 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | =100% | 7.3 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=60% | 47.6 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 | >=30% | 71.7 percentage of participants |
Secondary
Percentage of Participants With Total Joint Replacements
Percentage of participants who underwent total knee, hip or shoulder joint replacement surgery.
Time frame: Baseline up to Week 40
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 | 1.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Total Joint Replacements | 3.5 percentage of participants |
| Tanezumab 2.5/5 mg | Percentage of Participants With Total Joint Replacements | 6.9 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 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). 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 2.5/5 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: 0.0809Log 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: 0.0239Log 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 osteoarthritis 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 | 4.6 units on a scale | Standard Deviation 12.96 |
| Placebo | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Impairment While Working | 60.9 units on a scale | Standard Deviation 19.51 |
| Placebo | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Overall Work Impairment | 62.3 units on a scale | Standard Deviation 20.42 |
| Placebo | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Activity Impairment | 69.4 units on a scale | Standard Deviation 14.62 |
| Tanezumab 2.5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Activity Impairment | 68.3 units on a scale | Standard Deviation 15.56 |
| Tanezumab 2.5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Work Time Missed | 7.4 units on a scale | Standard Deviation 17.42 |
| Tanezumab 2.5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Overall Work Impairment | 61.8 units on a scale | Standard Deviation 22.28 |
| Tanezumab 2.5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Impairment While Working | 59.5 units on a scale | Standard Deviation 21.57 |
| Tanezumab 2.5/5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Activity Impairment | 69.8 units on a scale | Standard Deviation 16 |
| Tanezumab 2.5/5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Impairment While Working | 60.1 units on a scale | Standard Deviation 21.39 |
| Tanezumab 2.5/5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Overall Work Impairment | 62.0 units on a scale | Standard Deviation 21.61 |
| Tanezumab 2.5/5 mg | Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline | Percent Work Time Missed | 8.4 units on a scale | Standard Deviation 18.15 |