Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
Keywords
Double-blind safety
Brief summary
This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.
Detailed description
Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Interventions
DRUGTanezumab 2.5 mg
Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
DRUGTanezumab 5 mg
Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
DRUGTanezumab 10 mg
Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);
Exclusion criteria
* Body mass index (BMI) of \>39 kg/m2; * Pregnancy or intent to become pregnant * Planned surgical procedure during the duration of the study * History of clinically significant cardiovascular, central nervous system or psychiatric disease * Previous exposure to exogenous NGF or to an anti NGF antibody; * Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Injection-Site Reactions at Week 40 | Week 40 | Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion). |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32 | Baseline, Week 32 | NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40 | Baseline, Week 40 | NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48 | Baseline, Week 48 | NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment. |
| Number of Participants With Clinically Significant Change From Baseline in Physical Findings | Baseline to Week 50 | Physical examination included examination of abdomen, ears, extremities, eyes, head, heart, lungs, lymph nodes, neck, nose, skin, throat, thyroid, muscoskeletal, neurological and peripheral vascular system. |
| Number of Participants With Anti-Drug Antibody (ADA) at Day 1 | Day 1 | Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). |
| Number of Participants With Anti-Drug Antibody (ADA) at Week 8 | Week 8 | Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA. |
| Number of Participants With Anti-Drug Antibody (ADA) at Week 24 | Week 24 | Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA. |
| Number of Participants With Anti-Drug Antibody (ADA) at Week 50 | Week 50 | Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA. |
| Number of Participants With Vital Sign Abnormalities | Baseline up to Week 50 | Examination of vital signs included body temperature, systolic blood pressure, diastolic blood pressure, pulse rate and respiratory rate. Participants with abnormal vital sign findings reported as adverse events were presented. |
| Number of Participants With Injection-Site Reactions at Day 1 | Day 1 | Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion). |
| Number of Participants With Injection-Site Reactions at Week 2 | Week 2 | Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion). |
| Number of Participants With Injection-Site Reactions at Week 4 | Week 4 | Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion). |
| Number of Participants With Injection-Site Reactions at Week 8 | Week 8 | Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion). |
| Number of Participants With Injection-Site Reactions at Week 16 | Week 16 | Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion). |
| Number of Participants With Injection-Site Reactions at Week 24 | Week 24 | Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion). |
| Number of Participants With Injection-Site Reactions at Week 32 | Week 32 | Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion). |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to 112 days after last dose of study medication (up to 345 days) | 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 are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Number of Participants With Laboratory Abnormalities | Baseline to Week 50 | Laboratory analysis included blood chemistry, hematology, urinalysis and pregnancy test. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline up to Week 50 | All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula \[QTcF\], QT interval corrected for heart rate using Bazett's formula \[QTcB\], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as adverse events were presented. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2 | Baseline, Week 2 | NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4 | Baseline, Week 4 | NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8 | Baseline, Week 8 | NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16 | Baseline, Week 16 | NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24 | Baseline, Week 24 | NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56 | WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It was calculated as mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 to 10, where higher scores indicated higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56 | WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint and index hip during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on NRS of 0 to 10, with higher scores indicated worse function. Total score range for WOMAC physical function subscale score was 0 to 10, where higher scores indicated worse function. |
| Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56 | Participants answered: Considering all the ways your osteoarthritis in your knee (or hip) affects you, how are you doing today? Participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities). |
| Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 2, 4, 8, 16, 24, 32, 40, 48, 56 | OMERACT-OARSI response: greater than or equal to (\>=) 50 percent (%) improvement from baseline and absolute change from baseline of \>=2 units in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty). |
| Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2, 4, 8, 16, 24, 32, 40, 48, 56 | Percentage of participants with at least 30%, 50%, 70% and 90% reduction from baseline in WOMAC pain subscale score are reported. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It was calculated as mean of the scores from the 5 individual questions scored on a 0 to 10 NRS, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicated higher pain. |
| Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2, 4, 8, 16, 24, 32, 40, 48, 56 | WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 are reported. |
| Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 2, 4, 8, 16, 24, 32, 40, 48, 56 | Participants answered: Considering all the ways your osteoarthritis in your knee (or hip) affects you, how are you doing today? Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56 | WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or index hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of 0 to 10, with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee or hip. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. Each item was scored on a 0 to 10 NRS scale, where higher scores indicated higher pain/stiffness or worse function. WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranged from 0 to 10, where higher score indicated worse response. |
| Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 | Participants answered: How much pain have you had when walking on a flat surface? Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. |
| Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 | Participants answered: How much pain have you had when going up or down the stairs? Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. |
| Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 50 | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. |
| Number of Participants Who Discontinued Due to Lack of Efficacy | Baseline up to Week 50 | — |
| Percentage of Participants Who Used Concomitant Analgesic Medication | Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 | United States Food and Drug Administration (FDA) approved analgesics were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), capsaicin products and viscosupplementation (example, hyaluronan) and were prescribed at the discretion of the Investigator. |
| Days Per Week of Concomitant Analgesic Medication Usage | Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 | United States FDA-approved analgesics were permitted as concomitant medications to relieve the pain of OA. These medications included opioids, topical analgesics, NSAIDs, capsaicin products and viscosupplementation (example, hyaluronan) and were prescribed at the discretion of the Investigator. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Subcutaneous Doses of Study Medication | Day 1 up to Week 24 | Number of participants are reported based on the maximum number of subcutaneous doses of study medication received. |
Countries
United States
Participant flow
Pre-assignment details
Due to United States Food and Drug Administration (FDA) imposed clinical hold, study was terminated prematurely and a maximum of only 4 doses of the 7 planned doses of tanezumab (RN624 or PF-04383119) subcutaneous injection were administered in the study.
Participants by arm
| Arm | Count |
|---|---|
| Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) injection subcutaneously every 8 weeks up to 24 weeks. | 230 |
| Tanezumab 5 mg Tanezumab (RN624 or PF-04383119) 5 mg injection subcutaneously every 8 weeks up to 24 weeks. | 222 |
| Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg injection subcutaneously every 8 weeks up to 24 weeks. | 226 |
| Total | 678 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 9 | 11 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 6 | 1 | 3 |
| Overall Study | No longer willing to participate | 8 | 5 | 13 |
| Overall Study | Other | 2 | 2 | 1 |
| Overall Study | Protocol Violation | 2 | 4 | 0 |
| Overall Study | Randomized, but not treated | 1 | 0 | 0 |
| Overall Study | Study terminated by sponsor | 199 | 201 | 197 |
Baseline characteristics
| Characteristic | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg | Total |
|---|---|---|---|---|
| Age, Customized 18 to 44 years | 11 Participants | 7 Participants | 4 Participants | 22 Participants |
| Age, Customized 45 to 64 years | 128 Participants | 124 Participants | 113 Participants | 365 Participants |
| Age, Customized Greater than or equal to (>=) 65 years | 91 Participants | 91 Participants | 109 Participants | 291 Participants |
| Sex: Female, Male Female | 152 Participants | 157 Participants | 161 Participants | 470 Participants |
| Sex: Female, Male Male | 78 Participants | 65 Participants | 65 Participants | 208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 132 / 230 | 137 / 222 | 153 / 226 |
| serious Total, serious adverse events | 17 / 230 | 12 / 222 | 20 / 226 |
Outcome results
Primary
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Time frame: Baseline, Week 16
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16 | -0.60 units on a scale | Standard Deviation 2.24 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16 | -0.17 units on a scale | Standard Deviation 2.66 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16 | -0.24 units on a scale | Standard Deviation 2.61 |
Primary
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Time frame: Baseline, Week 2
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2 | Baseline | 2.04 units on a scale | Standard Deviation 3.93 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2 | Change at Week 2 | -0.43 units on a scale | Standard Deviation 1.51 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2 | Baseline | 1.52 units on a scale | Standard Deviation 3.17 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2 | Change at Week 2 | -0.36 units on a scale | Standard Deviation 2.04 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2 | Baseline | 1.76 units on a scale | Standard Deviation 3.53 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2 | Change at Week 2 | -0.23 units on a scale | Standard Deviation 1.78 |
Primary
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Time frame: Baseline, Week 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24 | -0.46 units on a scale | Standard Deviation 2.14 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24 | -0.38 units on a scale | Standard Deviation 2.53 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24 | -0.19 units on a scale | Standard Deviation 2.44 |
Primary
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Time frame: Baseline, Week 32
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32 | -0.72 units on a scale | Standard Deviation 2.15 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32 | -0.11 units on a scale | Standard Deviation 2.26 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32 | -0.34 units on a scale | Standard Deviation 3.02 |
Primary
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Time frame: Baseline, Week 4
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4 | -0.35 units on a scale | Standard Deviation 1.72 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4 | -0.15 units on a scale | Standard Deviation 2.12 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4 | -0.10 units on a scale | Standard Deviation 1.83 |
Primary
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Time frame: Baseline, Week 40
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40 | -0.82 units on a scale | Standard Deviation 2.11 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40 | -0.39 units on a scale | Standard Deviation 1.41 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40 | 0.00 units on a scale | Standard Deviation 3.98 |
Primary
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Time frame: Baseline, Week 48
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Results are not reported for Tanezumab 5 mg group because all participants in this group had discontinued the study before Week 48.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48 | -2.00 units on a scale |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48 | 0.00 units on a scale |
Primary
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Time frame: Baseline, Week 8
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8 | -0.39 units on a scale | Standard Deviation 2.1 |
| Tanezumab 5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8 | -0.08 units on a scale | Standard Deviation 2.3 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8 | -0.34 units on a scale | Standard Deviation 2.14 |
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula \[QTcF\], QT interval corrected for heart rate using Bazett's formula \[QTcB\], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as adverse events were presented.
Time frame: Baseline up to Week 50
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Supraventricular extrasystoles | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Atrioventricular block first degree | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Supraventricular tachycardia | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | ECG T wave inversion | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Bundle branch block right | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Tachycardia | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | ECG T wave abnormal | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | ECG QRS complex prolonged | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Bundle branch block right | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Atrioventricular block first degree | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | ECG T wave abnormal | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | ECG T wave inversion | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Supraventricular extrasystoles | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Supraventricular tachycardia | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Tachycardia | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | ECG QRS complex prolonged | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | ECG T wave inversion | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Atrioventricular block first degree | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Bundle branch block right | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Supraventricular extrasystoles | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Supraventricular tachycardia | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Tachycardia | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | ECG QRS complex prolonged | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | ECG T wave abnormal | 0 Participants |
Primary
Number of Participants With Anti-Drug Antibody (ADA) at Day 1
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 1
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Anti-Drug Antibody (ADA) at Day 1 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Drug Antibody (ADA) at Day 1 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Anti-Drug Antibody (ADA) at Day 1 | 1 Participants |
Primary
Number of Participants With Anti-Drug Antibody (ADA) at Week 24
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
Time frame: Week 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Anti-Drug Antibody (ADA) at Week 24 | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Drug Antibody (ADA) at Week 24 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Anti-Drug Antibody (ADA) at Week 24 | 0 Participants |
Primary
Number of Participants With Anti-Drug Antibody (ADA) at Week 50
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
Time frame: Week 50
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Anti-Drug Antibody (ADA) at Week 50 | 3 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Drug Antibody (ADA) at Week 50 | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Anti-Drug Antibody (ADA) at Week 50 | 1 Participants |
Primary
Number of Participants With Anti-Drug Antibody (ADA) at Week 8
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
Time frame: Week 8
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure at any time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Anti-Drug Antibody (ADA) at Week 8 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Anti-Drug Antibody (ADA) at Week 8 | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Anti-Drug Antibody (ADA) at Week 8 | 1 Participants |
Primary
Number of Participants With Clinically Significant Change From Baseline in Physical Findings
Physical examination included examination of abdomen, ears, extremities, eyes, head, heart, lungs, lymph nodes, neck, nose, skin, throat, thyroid, muscoskeletal, neurological and peripheral vascular system.
Time frame: Baseline to Week 50
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Clinically Significant Change From Baseline in Physical Findings | 13 Participants |
| Tanezumab 5 mg | Number of Participants With Clinically Significant Change From Baseline in Physical Findings | 13 Participants |
| Tanezumab 10 mg | Number of Participants With Clinically Significant Change From Baseline in Physical Findings | 18 Participants |
Primary
Number of Participants With Injection-Site Reactions at Day 1
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Time frame: Day 1
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Injection-Site Reactions at Day 1 | 9 Participants |
| Tanezumab 5 mg | Number of Participants With Injection-Site Reactions at Day 1 | 12 Participants |
| Tanezumab 10 mg | Number of Participants With Injection-Site Reactions at Day 1 | 9 Participants |
Primary
Number of Participants With Injection-Site Reactions at Week 16
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Time frame: Week 16
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Injection-Site Reactions at Week 16 | 2 Participants |
| Tanezumab 5 mg | Number of Participants With Injection-Site Reactions at Week 16 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Injection-Site Reactions at Week 16 | 1 Participants |
Primary
Number of Participants With Injection-Site Reactions at Week 2
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Time frame: Week 2
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Injection-Site Reactions at Week 2 | 7 Participants |
| Tanezumab 5 mg | Number of Participants With Injection-Site Reactions at Week 2 | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Injection-Site Reactions at Week 2 | 4 Participants |
Primary
Number of Participants With Injection-Site Reactions at Week 24
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Time frame: Week 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Injection-Site Reactions at Week 24 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Injection-Site Reactions at Week 24 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Injection-Site Reactions at Week 24 | 0 Participants |
Primary
Number of Participants With Injection-Site Reactions at Week 32
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Time frame: Week 32
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Injection-Site Reactions at Week 32 | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Injection-Site Reactions at Week 32 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Injection-Site Reactions at Week 32 | 0 Participants |
Primary
Number of Participants With Injection-Site Reactions at Week 4
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Time frame: Week 4
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Injection-Site Reactions at Week 4 | 1 Participants |
| Tanezumab 5 mg | Number of Participants With Injection-Site Reactions at Week 4 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Injection-Site Reactions at Week 4 | 1 Participants |
Primary
Number of Participants With Injection-Site Reactions at Week 40
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Time frame: Week 40
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Injection-Site Reactions at Week 40 | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Injection-Site Reactions at Week 40 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Injection-Site Reactions at Week 40 | 0 Participants |
Primary
Number of Participants With Injection-Site Reactions at Week 8
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Time frame: Week 8
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Injection-Site Reactions at Week 8 | 4 Participants |
| Tanezumab 5 mg | Number of Participants With Injection-Site Reactions at Week 8 | 6 Participants |
| Tanezumab 10 mg | Number of Participants With Injection-Site Reactions at Week 8 | 7 Participants |
Primary
Number of Participants With Laboratory Abnormalities
Laboratory analysis included blood chemistry, hematology, urinalysis and pregnancy test.
Time frame: Baseline to Week 50
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Laboratory Abnormalities | 136 Participants |
| Tanezumab 5 mg | Number of Participants With Laboratory Abnormalities | 121 Participants |
| Tanezumab 10 mg | Number of Participants With Laboratory Abnormalities | 130 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) or 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 are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to 112 days after last dose of study medication (up to 345 days)
Population: Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 158 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 17 Participants |
| Tanezumab 5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 169 Participants |
| Tanezumab 5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 12 Participants |
| Tanezumab 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 181 Participants |
| Tanezumab 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 20 Participants |
Primary
Number of Participants With Vital Sign Abnormalities
Examination of vital signs included body temperature, systolic blood pressure, diastolic blood pressure, pulse rate and respiratory rate. Participants with abnormal vital sign findings reported as adverse events were presented.
Time frame: Baseline up to Week 50
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Vital Sign Abnormalities | Hypertension | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Vital Sign Abnormalities | Blood pressure increased | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Vital Sign Abnormalities | Hypotension | 0 Participants |
| Tanezumab 5 mg | Number of Participants With Vital Sign Abnormalities | Hypertension | 4 Participants |
| Tanezumab 5 mg | Number of Participants With Vital Sign Abnormalities | Blood pressure increased | 3 Participants |
| Tanezumab 5 mg | Number of Participants With Vital Sign Abnormalities | Hypotension | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Vital Sign Abnormalities | Blood pressure increased | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Vital Sign Abnormalities | Hypotension | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Vital Sign Abnormalities | Hypertension | 5 Participants |
Secondary
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56
Participants answered: Considering all the ways your osteoarthritis in your knee (or hip) affects you, how are you doing today? Participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities).
Time frame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 2 | -0.70 units on a scale | Standard Deviation 0.78 |
| Tanezumab 2.5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 16 | -0.69 units on a scale | Standard Deviation 0.83 |
| Tanezumab 2.5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 8 | -0.72 units on a scale | Standard Deviation 0.8 |
| Tanezumab 2.5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Baseline | 3.38 units on a scale | Standard Deviation 0.59 |
| Tanezumab 2.5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 32 | -0.69 units on a scale | Standard Deviation 0.88 |
| Tanezumab 2.5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 24 | -0.71 units on a scale | Standard Deviation 0.87 |
| Tanezumab 2.5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 4 | -0.85 units on a scale | Standard Deviation 0.79 |
| Tanezumab 5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 8 | -0.83 units on a scale | Standard Deviation 0.83 |
| Tanezumab 5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Baseline | 3.36 units on a scale | Standard Deviation 0.57 |
| Tanezumab 5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 2 | -0.64 units on a scale | Standard Deviation 0.85 |
| Tanezumab 5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 4 | -0.86 units on a scale | Standard Deviation 0.86 |
| Tanezumab 5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 16 | -0.84 units on a scale | Standard Deviation 0.86 |
| Tanezumab 5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 24 | -0.82 units on a scale | Standard Deviation 0.88 |
| Tanezumab 5 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 32 | -0.82 units on a scale | Standard Deviation 0.88 |
| Tanezumab 10 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 16 | -0.80 units on a scale | Standard Deviation 0.91 |
| Tanezumab 10 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 2 | -0.64 units on a scale | Standard Deviation 0.84 |
| Tanezumab 10 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 32 | -0.80 units on a scale | Standard Deviation 0.88 |
| Tanezumab 10 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 24 | -0.80 units on a scale | Standard Deviation 0.88 |
| Tanezumab 10 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 8 | -0.82 units on a scale | Standard Deviation 0.92 |
| Tanezumab 10 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Change at Week 4 | -0.77 units on a scale | Standard Deviation 0.87 |
| Tanezumab 10 mg | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56 | Baseline | 3.32 units on a scale | Standard Deviation 0.53 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. Each item was scored on a 0 to 10 NRS scale, where higher scores indicated higher pain/stiffness or worse function. WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranged from 0 to 10, where higher score indicated worse response.
Time frame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -2.14 units on a scale | Standard Deviation 1.99 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.30 units on a scale | Standard Deviation 2.21 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.31 units on a scale | Standard Deviation 2.11 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.54 units on a scale | Standard Deviation 1.45 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.25 units on a scale | Standard Deviation 2.23 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.27 units on a scale | Standard Deviation 2.26 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.56 units on a scale | Standard Deviation 2.14 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.92 units on a scale | Standard Deviation 2.24 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.64 units on a scale | Standard Deviation 1.5 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -2.18 units on a scale | Standard Deviation 2.13 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.80 units on a scale | Standard Deviation 2.18 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.98 units on a scale | Standard Deviation 2.29 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.97 units on a scale | Standard Deviation 2.32 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.98 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.90 units on a scale | Standard Deviation 2.22 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.94 units on a scale | Standard Deviation 1.96 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.83 units on a scale | Standard Deviation 2.2 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.88 units on a scale | Standard Deviation 2.21 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.85 units on a scale | Standard Deviation 2.23 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.71 units on a scale | Standard Deviation 2.05 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.50 units on a scale | Standard Deviation 1.41 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It was calculated as mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 to 10, where higher scores indicated higher pain.
Time frame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -2.01 units on a scale | Standard Deviation 2.02 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.18 units on a scale | Standard Deviation 2.25 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.20 units on a scale | Standard Deviation 2.14 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.35 units on a scale | Standard Deviation 1.48 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.15 units on a scale | Standard Deviation 2.26 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.16 units on a scale | Standard Deviation 2.29 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.43 units on a scale | Standard Deviation 2.11 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.76 units on a scale | Standard Deviation 2.25 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.48 units on a scale | Standard Deviation 1.56 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.97 units on a scale | Standard Deviation 2.18 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.68 units on a scale | Standard Deviation 2.15 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.85 units on a scale | Standard Deviation 2.32 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.84 units on a scale | Standard Deviation 2.31 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.82 units on a scale | Standard Deviation 2.32 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.71 units on a scale | Standard Deviation 2.15 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.61 units on a scale | Standard Deviation 2 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.66 units on a scale | Standard Deviation 2.14 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.69 units on a scale | Standard Deviation 2.17 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.71 units on a scale | Standard Deviation 2.14 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.50 units on a scale | Standard Deviation 2.02 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.30 units on a scale | Standard Deviation 1.48 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint and index hip during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on NRS of 0 to 10, with higher scores indicated worse function. Total score range for WOMAC physical function subscale score was 0 to 10, where higher scores indicated worse function.
Time frame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -2.10 units on a scale | Standard Deviation 2.01 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.28 units on a scale | Standard Deviation 2.2 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.29 units on a scale | Standard Deviation 2.1 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.49 units on a scale | Standard Deviation 1.54 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.23 units on a scale | Standard Deviation 2.22 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.26 units on a scale | Standard Deviation 2.23 |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.50 units on a scale | Standard Deviation 2.16 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.83 units on a scale | Standard Deviation 2.26 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.58 units on a scale | Standard Deviation 1.55 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -2.13 units on a scale | Standard Deviation 2.15 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.70 units on a scale | Standard Deviation 2.22 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.89 units on a scale | Standard Deviation 2.35 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.89 units on a scale | Standard Deviation 2.37 |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.90 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.84 units on a scale | Standard Deviation 2.22 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.92 units on a scale | Standard Deviation 1.96 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.79 units on a scale | Standard Deviation 2.2 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.84 units on a scale | Standard Deviation 2.21 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.80 units on a scale | Standard Deviation 2.23 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.64 units on a scale | Standard Deviation 2.09 |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.47 units on a scale | Standard Deviation 1.53 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or index hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of 0 to 10, with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee or hip.
Time frame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -2.32 units on a scale |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.43 units on a scale |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.43 units on a scale |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.78 units on a scale |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.36 units on a scale |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.41 units on a scale |
| Tanezumab 2.5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.73 units on a scale |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -3.17 units on a scale |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.85 units on a scale |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -2.42 units on a scale |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -3.01 units on a scale |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.20 units on a scale |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -3.20 units on a scale |
| Tanezumab 5 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -3.21 units on a scale |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.15 units on a scale |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -2.29 units on a scale |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -3.05 units on a scale |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -3.10 units on a scale |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -3.05 units on a scale |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.99 units on a scale |
| Tanezumab 10 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.73 units on a scale |
Secondary
Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
Participants answered: How much pain have you had when going up or down the stairs? Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.51 units on a scale | Standard Deviation 2.63 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 7.52 units on a scale | Standard Deviation 1.64 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -2.34 units on a scale | Standard Deviation 2.28 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.86 units on a scale | Standard Deviation 2.58 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.60 units on a scale | Standard Deviation 2.48 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.47 units on a scale | Standard Deviation 2.66 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.46 units on a scale | Standard Deviation 2.63 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -3.03 units on a scale | Standard Deviation 2.59 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -3.01 units on a scale | Standard Deviation 2.66 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 7.64 units on a scale | Standard Deviation 1.68 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -3.01 units on a scale | Standard Deviation 2.47 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -3.00 units on a scale | Standard Deviation 2.67 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -2.25 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.05 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.99 units on a scale | Standard Deviation 2.3 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.77 units on a scale | Standard Deviation 2.45 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.94 units on a scale | Standard Deviation 2.54 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -3.01 units on a scale | Standard Deviation 2.53 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -3.01 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 7.54 units on a scale | Standard Deviation 1.72 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.98 units on a scale | Standard Deviation 2.55 |
Secondary
Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
Participants answered: How much pain have you had when walking on a flat surface? Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.95 units on a scale | Standard Deviation 2.17 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.00 units on a scale | Standard Deviation 2.54 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.03 units on a scale | Standard Deviation 2.42 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.15 units on a scale | Standard Deviation 1.86 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -1.96 units on a scale | Standard Deviation 2.51 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -1.96 units on a scale | Standard Deviation 2.55 |
| Tanezumab 2.5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.26 units on a scale | Standard Deviation 2.31 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.65 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.32 units on a scale | Standard Deviation 1.84 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.94 units on a scale | Standard Deviation 2.38 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.59 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.66 units on a scale | Standard Deviation 2.48 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.65 units on a scale | Standard Deviation 2.51 |
| Tanezumab 5 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.63 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 16 | -2.57 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 2 | -1.67 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 32 | -2.56 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 24 | -2.60 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 8 | -2.63 units on a scale | Standard Deviation 2.32 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Change at Week 4 | -2.45 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg | Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline | 6.20 units on a scale | Standard Deviation 1.86 |
Secondary
Days Per Week of Concomitant Analgesic Medication Usage
United States FDA-approved analgesics were permitted as concomitant medications to relieve the pain of OA. These medications included opioids, topical analgesics, NSAIDs, capsaicin products and viscosupplementation (example, hyaluronan) and were prescribed at the discretion of the Investigator.
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group. Data were not collected beyond Week 48 due to premature termination of the study in response to FDA clinical hold.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tanezumab 2.5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 2 | 7.0 days per week |
| Tanezumab 2.5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 32 | 0.0 days per week |
| Tanezumab 2.5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 8 | 7.0 days per week |
| Tanezumab 2.5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 16 | 2.5 days per week |
| Tanezumab 2.5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 24 | 0.0 days per week |
| Tanezumab 2.5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 40 | 7.0 days per week |
| Tanezumab 2.5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 4 | 7.0 days per week |
| Tanezumab 5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 48 | 0.0 days per week |
| Tanezumab 5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 8 | 0.0 days per week |
| Tanezumab 5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 2 | 0.0 days per week |
| Tanezumab 5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 4 | 0.0 days per week |
| Tanezumab 5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 16 | 0.0 days per week |
| Tanezumab 5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 24 | 0.0 days per week |
| Tanezumab 5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 32 | 0.0 days per week |
| Tanezumab 5 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 40 | 0.0 days per week |
| Tanezumab 10 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 4 | 7.0 days per week |
| Tanezumab 10 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 40 | 7.0 days per week |
| Tanezumab 10 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 32 | 7.0 days per week |
| Tanezumab 10 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 2 | 7.0 days per week |
| Tanezumab 10 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 16 | 0.4 days per week |
| Tanezumab 10 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 8 | 2.9 days per week |
| Tanezumab 10 mg | Days Per Week of Concomitant Analgesic Medication Usage | Week 24 | 0.0 days per week |
Secondary
Number of Participants Who Discontinued Due to Lack of Efficacy
Time frame: Baseline up to Week 50
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 2.5 mg | Number of Participants Who Discontinued Due to Lack of Efficacy | 0 Participants |
| Tanezumab 5 mg | Number of Participants Who Discontinued Due to Lack of Efficacy | 0 Participants |
| Tanezumab 10 mg | Number of Participants Who Discontinued Due to Lack of Efficacy | 1 Participants |
Secondary
Percentage of Participants Who Used Concomitant Analgesic Medication
United States Food and Drug Administration (FDA) approved analgesics were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), capsaicin products and viscosupplementation (example, hyaluronan) and were prescribed at the discretion of the Investigator.
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64
Population: ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group. Data were not collected beyond Week 48 due to premature termination of the study in response to FDA clinical hold.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 4 | 52.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 32 | 33.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 16 | 50.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 2 | 53.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 24 | 49.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 40 | 100 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 8 | 53.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 48 | 0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 2 | 49.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 4 | 47.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 8 | 47.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 16 | 47.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 24 | 49.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 32 | 47.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 40 | 0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 8 | 51.6 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 40 | 100 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 32 | 52.2 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 4 | 51.6 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 16 | 50.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 2 | 52.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Used Concomitant Analgesic Medication | Week 24 | 48.9 percentage of participants |
Secondary
Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Percentage of participants with at least 30%, 50%, 70% and 90% reduction from baseline in WOMAC pain subscale score are reported. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It was calculated as mean of the scores from the 5 individual questions scored on a 0 to 10 NRS, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicated higher pain.
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 70% reduction | 21.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 50% reduction | 28.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 70% reduction | 13.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 90% reduction | 4.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 30% reduction | 57.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 50% reduction | 39.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 30% reduction | 48.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 90% reduction | 7.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 30% reduction | 50.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 50% reduction | 35.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 70% reduction | 18.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 90% reduction | 7.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 30% reduction | 52.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 50% reduction | 37.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 70% reduction | 20.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 90% reduction | 6.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 30% reduction | 50.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 50% reduction | 37.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 70% reduction | 20.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 90% reduction | 7.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 30% reduction | 51.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 50% reduction | 36.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 70% reduction | 20.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 90% reduction | 6.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 50% reduction | 49.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 30% reduction | 49.1 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 30% reduction | 62.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 30% reduction | 62.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 50% reduction | 31.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 70% reduction | 26.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 30% reduction | 62.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 70% reduction | 16.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 50% reduction | 50.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 70% reduction | 27.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 90% reduction | 3.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 50% reduction | 46.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 50% reduction | 50.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 30% reduction | 62.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 70% reduction | 28.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 90% reduction | 11.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 50% reduction | 40.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 30% reduction | 62.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 90% reduction | 11.4 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 70% reduction | 24.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 90% reduction | 11.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 70% reduction | 28.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 90% reduction | 6.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 90% reduction | 11.8 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 90% reduction | 6.3 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 30% reduction | 66.2 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 50% reduction | 46.4 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 70% reduction | 27.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 90% reduction | 11.7 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 8: at least 90% reduction | 10.8 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 70% reduction | 27.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 30% reduction | 65.3 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 50% reduction | 45.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 30% reduction | 64.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 70% reduction | 28.4 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 90% reduction | 11.3 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: at least 90% reduction | 12.2 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 30% reduction | 41.4 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 50% reduction | 23.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 30% reduction | 65.3 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 70% reduction | 14.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 32: at least 50% reduction | 44.1 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 2: at least 90% reduction | 3.6 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 30% reduction | 60.4 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 50% reduction | 45.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 50% reduction | 41.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 4: at least 70% reduction | 22.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 24: at least 70% reduction | 28.8 percentage of participants |
Secondary
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 are reported.
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=70% | 28.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=80% | 18.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=90% | 9.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=30% | 58.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: 100% | 4.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=10% | 74.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=40% | 47.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=50% | 43.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: greater than (>) 0% | 82.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=60% | 33.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=20% | 65.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=50% | 51.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=20% | 71.9 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=60% | 41.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=80% | 21.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: greater than (>) 0% | 85.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=40% | 57.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=90% | 14.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=10% | 81.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=70% | 32.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: 100% | 3.7 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=30% | 63.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: 100% | 5.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=10% | 82.2 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=20% | 73.7 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=30% | 67.8 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=40% | 60.2 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=50% | 50.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=60% | 41.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=70% | 33.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=80% | 22.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: >=90% | 14.4 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Week 16: greater than (>) 0% | 89.0 percentage of participants |
Secondary
Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis
Participants answered: Considering all the ways your osteoarthritis in your knee (or hip) affects you, how are you doing today? Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value.
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 2 | 14.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 4 | 20.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 8 | 15.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 16 | 15.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 24 | 16.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 32 | 16.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 32 | 18.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 2 | 15.8 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 16 | 18.0 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 24 | 18.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 4 | 20.3 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 8 | 18.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 4 | 16.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 8 | 24.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 32 | 20.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 16 | 20.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 2 | 13.3 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis | Week 24 | 20.0 percentage of participants |
Secondary
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
OMERACT-OARSI response: greater than or equal to (\>=) 50 percent (%) improvement from baseline and absolute change from baseline of \>=2 units in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \>=20% improvement from baseline and absolute change from baseline of \>=1 unit in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Population: ITT analysis set. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Missing data was imputed using last observation carried forward (LOCF) method. Due to implementation of the FDA clinical hold, all ongoing participants were discontinued from treatment and did not have an opportunity to complete the 56-week treatment period and no efficacy data beyond the Week 32 visit (i.e., Weeks 40, 48 and 56) was collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 2.5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 2 | 57.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 4 | 64.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 8 | 61.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 16 | 59.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 24 | 58.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 32 | 58.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 32 | 68.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 2 | 58.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 16 | 68.6 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 24 | 68.2 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 4 | 70.5 percentage of participants |
| Tanezumab 5 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 8 | 68.6 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 4 | 73.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 8 | 70.9 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 32 | 71.7 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 16 | 72.2 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 2 | 49.3 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | Week 24 | 71.7 percentage of participants |
Secondary
Time to Discontinuation Due to Lack of Efficacy
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Time frame: Baseline up to Week 50
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tanezumab 2.5 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tanezumab 5 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tanezumab 10 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
Other Pre-specified
Number of Participants With Subcutaneous Doses of Study Medication
Number of participants are reported based on the maximum number of subcutaneous doses of study medication received.
Time frame: Day 1 up to Week 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 2.5 mg | Number of Participants With Subcutaneous Doses of Study Medication | 1 dose | 48 Participants |
| Tanezumab 2.5 mg | Number of Participants With Subcutaneous Doses of Study Medication | 2 doses | 99 Participants |
| Tanezumab 2.5 mg | Number of Participants With Subcutaneous Doses of Study Medication | 3 doses | 64 Participants |
| Tanezumab 2.5 mg | Number of Participants With Subcutaneous Doses of Study Medication | 4 doses | 19 Participants |
| Tanezumab 5 mg | Number of Participants With Subcutaneous Doses of Study Medication | 4 doses | 25 Participants |
| Tanezumab 5 mg | Number of Participants With Subcutaneous Doses of Study Medication | 1 dose | 36 Participants |
| Tanezumab 5 mg | Number of Participants With Subcutaneous Doses of Study Medication | 3 doses | 72 Participants |
| Tanezumab 5 mg | Number of Participants With Subcutaneous Doses of Study Medication | 2 doses | 89 Participants |
| Tanezumab 10 mg | Number of Participants With Subcutaneous Doses of Study Medication | 4 doses | 24 Participants |
| Tanezumab 10 mg | Number of Participants With Subcutaneous Doses of Study Medication | 2 doses | 103 Participants |
| Tanezumab 10 mg | Number of Participants With Subcutaneous Doses of Study Medication | 3 doses | 61 Participants |
| Tanezumab 10 mg | Number of Participants With Subcutaneous Doses of Study Medication | 1 dose | 38 Participants |