A Phase 2 interventional study of Tanezumab 2.5 mg and Tanezumab 5 mg in Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by Pfizer. Terminated at 100 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-13.
Sponsored by Pfizer · Phase 2, Interventional, and Other
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 679 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Tanezumab 2.5 mg
Drug: Tanezumab 5 mg
Drug: Tanezumab 10 mg
Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
Also known as: Biological
Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
Also known as: Biological
Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
Also known as: Biological
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)
Number of Participants With Laboratory Abnormalities
Laboratory analysis included blood chemistry, hematology, urinalysis and pregnancy test.
Time frame: Baseline to Week 50
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Number of Participants Who Discontinued Due to Lack of Efficacy
Time frame: Baseline up to Week 50
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
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
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
| Milestone | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Started | 231 | 222 | 226 |
| Treated | 230 | 222 | 226 |
| Completed | 0 | 0 | 0 |
| Not completed | 231 | 222 | 226 |
| Withdrew: Adverse event | 13 | 9 | 11 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 6 | 1 | 3 |
| Withdrew: No longer willing to participate | 8 | 5 | 13 |
| Withdrew: Protocol violation | 2 | 4 | 0 |
| Withdrew: Study terminated by sponsor | 199 | 201 | 197 |
| Withdrew: Randomized, but not treated | 1 | 0 | 0 |
| Withdrew: Other | 2 | 2 | 1 |
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.
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| AEs | 158 | 169 | 181 |
| SAEs | 17 | 12 | 20 |
Laboratory analysis included blood chemistry, hematology, urinalysis and pregnancy test.
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Laboratory Abnormalities | 136 | 121 | 130 |
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.
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Atrioventricular block first degree | 0 | 1 | 0 |
| Bundle branch block right | 0 | 0 | 1 |
| Supraventricular extrasystoles | 0 | 0 | 1 |
| Supraventricular tachycardia | 0 | 1 | 0 |
| Tachycardia | 1 | 1 | 2 |
| ECG QRS complex prolonged | 1 | 0 | 0 |
| ECG T wave abnormal | 0 | 1 | 0 |
| ECG T wave inversion | 1 | 0 | 1 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Baseline | 2.04 ± 3.93 | 1.52 ± 3.17 | 1.76 ± 3.53 |
| Change at Week 2 | -0.43 ± 1.51 | -0.36 ± 2.04 | -0.23 ± 1.78 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4 | -0.35 ± 1.72 | -0.15 ± 2.12 | -0.10 ± 1.83 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8 | -0.39 ± 2.10 | -0.08 ± 2.30 | -0.34 ± 2.14 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16 | -0.60 ± 2.24 | -0.17 ± 2.66 | -0.24 ± 2.61 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24 | -0.46 ± 2.14 | -0.38 ± 2.53 | -0.19 ± 2.44 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32 | -0.72 ± 2.15 | -0.11 ± 2.26 | -0.34 ± 3.02 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40 | -0.82 ± 2.11 | -0.39 ± 1.41 | 0.00 ± 3.98 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48 | -2.00 ± NA | — | 0.00 ± NA |
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.
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Clinically Significant Change From Baseline in Physical Findings | 13 | 13 | 18 |
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).
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Anti-Drug Antibody (ADA) at Day 1 | 1 | 1 | 1 |
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Anti-Drug Antibody (ADA) at Week 8 | 1 | 2 | 1 |
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Anti-Drug Antibody (ADA) at Week 24 | 0 | 1 | 0 |
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Anti-Drug Antibody (ADA) at Week 50 | 3 | 3 | 1 |
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.
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Blood pressure increased | 0 | 3 | 1 |
| Hypertension | 8 | 4 | 5 |
| Hypotension | 0 | 0 | 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).
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Injection-Site Reactions at Day 1 | 9 | 12 | 9 |
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).
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Injection-Site Reactions at Week 2 | 7 | 3 | 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).
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Injection-Site Reactions at Week 4 | 1 | 1 | 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).
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Injection-Site Reactions at Week 8 | 4 | 6 | 7 |
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).
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Injection-Site Reactions at Week 16 | 2 | 1 | 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).
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Injection-Site Reactions at Week 24 | 1 | 0 | 0 |
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).
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Injection-Site Reactions at Week 32 | 0 | 0 | 0 |
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).
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants With Injection-Site Reactions at Week 40 | 0 | 0 | 0 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Baseline | 6.35 ± 1.48 | 6.48 ± 1.56 | 6.30 ± 1.48 |
| Change at Week 2 | -2.01 ± 2.02 | -1.97 ± 2.18 | -1.61 ± 2.00 |
| Change at Week 4 | -2.43 ± 2.11 | -2.68 ± 2.15 | -2.50 ± 2.02 |
| Change at Week 8 | -2.20 ± 2.14 | -2.76 ± 2.25 | -2.71 ± 2.14 |
| Change at Week 16 | -2.18 ± 2.25 | -2.85 ± 2.32 | -2.71 ± 2.15 |
| Change at Week 24 | -2.16 ± 2.29 | -2.84 ± 2.31 | -2.69 ± 2.17 |
| Change at Week 32 | -2.15 ± 2.26 | -2.82 ± 2.32 | -2.66 ± 2.14 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Baseline | 6.49 ± 1.54 | 6.58 ± 1.55 | 6.47 ± 1.53 |
| Change at Week 2 | -2.10 ± 2.01 | -2.13 ± 2.15 | -1.92 ± 1.96 |
| Change at Week 4 | -2.50 ± 2.16 | -2.70 ± 2.22 | -2.64 ± 2.09 |
| Change at Week 8 | -2.29 ± 2.10 | -2.83 ± 2.26 | -2.80 ± 2.23 |
| Change at Week 16 | -2.28 ± 2.20 | -2.89 ± 2.35 | -2.84 ± 2.22 |
| Change at Week 24 | -2.26 ± 2.23 | -2.89 ± 2.37 | -2.84 ± 2.21 |
| Change at Week 32 | -2.23 ± 2.22 | -2.90 ± 2.36 | -2.79 ± 2.20 |
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).
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Baseline | 3.38 ± 0.59 | 3.36 ± 0.57 | 3.32 ± 0.53 |
| Change at Week 2 | -0.70 ± 0.78 | -0.64 ± 0.85 | -0.64 ± 0.84 |
| Change at Week 4 | -0.85 ± 0.79 | -0.86 ± 0.86 | -0.77 ± 0.87 |
| Change at Week 8 | -0.72 ± 0.80 | -0.83 ± 0.83 | -0.82 ± 0.92 |
| Change at Week 16 | -0.69 ± 0.83 | -0.84 ± 0.86 | -0.80 ± 0.91 |
| Change at Week 24 | -0.71 ± 0.87 | -0.82 ± 0.88 | -0.80 ± 0.88 |
| Change at Week 32 | -0.69 ± 0.88 | -0.82 ± 0.88 | -0.80 ± 0.88 |
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 | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Week 2 | 57.8 (51 to 64) | 58.6 (52 to 65) | 49.3 (43 to 56) |
| Week 4 | 64.9 (59 to 71) | 70.5 (64 to 76) | 73.5 (68 to 79) |
| Week 8 | 61.8 (55 to 68) | 68.6 (63 to 75) | 70.9 (65 to 77) |
| Week 16 | 59.1 (53 to 66) | 68.6 (63 to 75) | 72.2 (66 to 78) |
| Week 24 | 58.7 (52 to 65) | 68.2 (62 to 74) | 71.7 (66 to 78) |
| Week 32 | 58.2 (52 to 65) | 68.2 (62 to 74) | 71.7 (66 to 78) |
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 | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Week 2: at least 30% reduction | 48.9 (42 to 55) | 49.1 (42 to 56) | 41.4 (35 to 48) |
| Week 2: at least 50% reduction | 28.4 (23 to 34) | 31.4 (25 to 37) | 23.9 (18 to 29) |
| Week 2: at least 70% reduction | 13.8 (9 to 18) | 16.8 (12 to 22) | 14.0 (9 to 19) |
| Week 2: at least 90% reduction | 4.9 (2 to 8) | 3.6 (1 to 6) | 3.6 (1 to 6) |
| Week 4: at least 30% reduction | 57.3 (51 to 64) | 62.7 (56 to 69) | 60.4 (54 to 67) |
| Week 4: at least 50% reduction | 39.1 (33 to 45) | 40.9 (34 to 47) | 41.0 (35 to 47) |
| Week 4: at least 70% reduction | 21.3 (16 to 27) | 24.5 (19 to 30) | 22.5 (17 to 28) |
| Week 4: at least 90% reduction | 7.6 (4 to 11) | 6.8 (3 to 10) | 6.3 (3 to 10) |
| Week 8: at least 30% reduction | 50.7 (44 to 57) | 62.7 (56 to 69) | 66.2 (60 to 72) |
| Week 8: at least 50% reduction | 35.1 (29 to 41) | 46.4 (40 to 53) | 46.4 (40 to 53) |
| Week 8: at least 70% reduction | 18.2 (13 to 23) | 26.8 (21 to 33) | 27.0 (21 to 33) |
| Week 8: at least 90% reduction | 7.6 (4 to 11) | 11.4 (7 to 16) | 10.8 (7 to 15) |
| Week 16: at least 30% reduction | 52.4 (46 to 59) | 62.3 (56 to 69) | 65.3 (59 to 72) |
| Week 16: at least 50% reduction | 37.3 (31 to 44) | 50.0 (43 to 57) | 45.5 (39 to 52) |
| Week 16: at least 70% reduction | 20.4 (15 to 26) | 28.6 (23 to 35) | 28.4 (22 to 34) |
| Week 16: at least 90% reduction | 6.2 (3 to 9) | 11.8 (8 to 16) | 12.2 (8 to 16) |
| Week 24: at least 30% reduction | 50.2 (44 to 57) | 62.7 (56 to 69) | 65.3 (59 to 72) |
| Week 24: at least 50% reduction | 37.3 (31 to 44) | 50.0 (43 to 57) | 45.5 (39 to 52) |
| Week 24: at least 70% reduction | 20.4 (15 to 26) | 28.2 (22 to 34) | 28.8 (23 to 35) |
| Week 24: at least 90% reduction | 7.1 (4 to 10) | 11.8 (8 to 16) | 11.7 (7 to 16) |
| Week 32: at least 30% reduction | 51.1 (45 to 58) | 62.3 (56 to 69) | 64.9 (59 to 71) |
| Week 32: at least 50% reduction | 36.9 (31 to 43) | 49.5 (43 to 56) | 44.1 (38 to 51) |
| Week 32: at least 70% reduction | 20.4 (15 to 26) | 27.7 (22 to 34) | 27.9 (22 to 34) |
| Week 32: at least 90% reduction | 6.7 (3 to 10) | 11.4 (7 to 16) | 11.3 (7 to 15) |
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 | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Week 16: greater than (>) 0% | 82.6 | 85.2 | 89.0 |
| Week 16: >=10% | 74.8 | 81.5 | 82.2 |
| Week 16: >=20% | 65.2 | 71.9 | 73.7 |
| Week 16: >=30% | 58.3 | 63.0 | 67.8 |
| Week 16: >=40% | 47.0 | 57.0 | 60.2 |
| Week 16: >=50% | 43.5 | 51.9 | 50.0 |
| Week 16: >=60% | 33.0 | 41.5 | 41.5 |
| Week 16: >=70% | 28.7 | 32.6 | 33.9 |
| Week 16: >=80% | 18.3 | 21.5 | 22.9 |
| Week 16: >=90% | 9.6 | 14.8 | 14.4 |
| Week 16: 100% | 4.3 | 3.7 | 5.9 |
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.
| percentage of participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Week 2 | 14.5 (10 to 19) | 15.8 (11 to 21) | 13.3 (9 to 18) |
| Week 4 | 20.2 (15 to 25) | 20.3 (15 to 26) | 16.9 (12 to 22) |
| Week 8 | 15.8 (11 to 21) | 18.9 (14 to 24) | 24.9 (19 to 31) |
| Week 16 | 15.4 (11 to 20) | 18.0 (13 to 23) | 20.9 (16 to 26) |
| Week 24 | 16.7 (12 to 22) | 18.5 (13 to 24) | 20.0 (15 to 25) |
| Week 32 | 16.2 (11 to 21) | 18.5 (13 to 24) | 20.0 (15 to 25) |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Baseline | 6.78 (6.55 to 7.01) | 6.85 (6.61 to 7.08) | 6.73 (6.50 to 6.95) |
| Change at Week 2 | -2.32 (-2.63 to -2.02) | -2.42 (-2.75 to -2.10) | -2.29 (-2.61 to -1.98) |
| Change at Week 4 | -2.73 (-3.05 to -2.40) | -3.01 (-3.34 to -2.68) | -2.99 (-3.31 to -2.67) |
| Change at Week 8 | -2.43 (-2.75 to -2.10) | -3.17 (-3.50 to -2.84) | -3.05 (-3.41 to -2.69) |
| Change at Week 16 | -2.43 (-2.76 to -2.10) | -3.20 (-3.54 to -2.87) | -3.15 (-3.50 to -2.80) |
| Change at Week 24 | -2.41 (-2.75 to -2.07) | -3.20 (-3.54 to -2.86) | -3.10 (-3.45 to -2.75) |
| Change at Week 32 | -2.36 (-2.70 to -2.03) | -3.21 (-3.55 to -2.87) | -3.05 (-3.40 to -2.71) |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Baseline | 6.54 ± 1.45 | 6.64 ± 1.50 | 6.50 ± 1.41 |
| Change at Week 2 | -2.14 ± 1.99 | -2.18 ± 2.13 | -1.94 ± 1.96 |
| Change at Week 4 | -2.56 ± 2.14 | -2.80 ± 2.18 | -2.71 ± 2.05 |
| Change at Week 8 | -2.31 ± 2.11 | -2.92 ± 2.24 | -2.85 ± 2.23 |
| Change at Week 16 | -2.30 ± 2.21 | -2.98 ± 2.29 | -2.90 ± 2.22 |
| Change at Week 24 | -2.27 ± 2.26 | -2.97 ± 2.32 | -2.88 ± 2.21 |
| Change at Week 32 | -2.25 ± 2.23 | -2.98 ± 2.31 | -2.83 ± 2.20 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Baseline | 6.15 ± 1.86 | 6.32 ± 1.84 | 6.20 ± 1.86 |
| Change at Week 2 | -1.95 ± 2.17 | -1.94 ± 2.38 | -1.67 ± 2.34 |
| Change at Week 4 | -2.26 ± 2.31 | -2.59 ± 2.34 | -2.45 ± 2.29 |
| Change at Week 8 | -2.03 ± 2.42 | -2.65 ± 2.50 | -2.63 ± 2.32 |
| Change at Week 16 | -2.00 ± 2.54 | -2.66 ± 2.48 | -2.57 ± 2.46 |
| Change at Week 24 | -1.96 ± 2.55 | -2.65 ± 2.51 | -2.60 ± 2.42 |
| Change at Week 32 | -1.96 ± 2.51 | -2.63 ± 2.51 | -2.56 ± 2.43 |
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.
| units on a scale | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Baseline | 7.52 ± 1.64 | 7.64 ± 1.68 | 7.54 ± 1.72 |
| Change at Week 2 | -2.34 ± 2.28 | -2.25 ± 2.43 | -1.99 ± 2.30 |
| Change at Week 4 | -2.86 ± 2.58 | -3.01 ± 2.47 | -2.77 ± 2.45 |
| Change at Week 8 | -2.60 ± 2.48 | -3.03 ± 2.59 | -3.01 ± 2.53 |
| Change at Week 16 | -2.51 ± 2.63 | -3.05 ± 2.67 | -3.01 ± 2.62 |
| Change at Week 24 | -2.47 ± 2.66 | -3.00 ± 2.67 | -2.98 ± 2.55 |
| Change at Week 32 | -2.46 ± 2.63 | -3.01 ± 2.66 | -2.94 ± 2.54 |
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
| days | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Time to Discontinuation Due to Lack of Efficacy | NA (NA to NA) | NA (NA to NA) | NA (82.0 to 82.0) |
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Number of Participants Who Discontinued Due to Lack of Efficacy | 0 | 0 | 1 |
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.
| percentage of participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Week 2 | 53.8 (47 to 60) | 49.8 (43 to 56) | 52.5 (46 to 59) |
| Week 4 | 52.9 (46 to 59) | 47.7 (41 to 54) | 51.6 (45 to 58) |
| Week 8 | 53.7 (47 to 60) | 47.9 (41 to 55) | 51.6 (45 to 58) |
| Week 16 | 50.6 (43 to 58) | 47.8 (40 to 55) | 50.5 (43 to 58) |
| Week 24 | 49.5 (39 to 60) | 49.0 (39 to 59) | 48.9 (38 to 59) |
| Week 32 | 33.3 (12 to 55) | 47.6 (26 to 69) | 52.2 (32 to 73) |
| Week 40 | 100 (100 to 100) | 0 (0 to 0) | 100 (100 to 100) |
| Week 48 | — | 0 (0 to 0) | — |
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.
| days per week | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| Week 2 | 7.0 (0.0 to 7.0) | 0.0 (0.0 to 7.0) | 7.0 (0.0 to 7.0) |
| Week 4 | 7.0 (0.0 to 7.0) | 0.0 (0.0 to 7.0) | 7.0 (0.0 to 7.0) |
| Week 8 | 7.0 (0.0 to 7.0) | 0.0 (0.0 to 7.0) | 2.9 (0.0 to 7.0) |
| Week 16 | 2.5 (0.0 to 7.0) | 0.0 (0.0 to 7.0) | 0.4 (0.0 to 7.0) |
| Week 24 | 0.0 (0.0 to 7.0) | 0.0 (0.0 to 7.0) | 0.0 (0.0 to 7.0) |
| Week 32 | 0.0 (0.0 to 7.0) | 0.0 (0.0 to 7.0) | 7.0 (0.0 to 7.0) |
| Week 40 | 7.0 (7.0 to 7.0) | 0.0 (0.0 to 0.0) | 7.0 (7.0 to 7.0) |
| Week 48 | — | 0.0 (0.0 to 0.0) | — |
Number of participants are reported based on the maximum number of subcutaneous doses of study medication received.
| Participants | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| 1 dose | 48 | 36 | 38 |
| 2 doses | 99 | 89 | 103 |
| 3 doses | 64 | 72 | 61 |
| 4 doses | 19 | 25 | 24 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tanezumab 2.5 mg | — | 17/230 (7.4%) | 132/230 (57.4%) |
| Tanezumab 5 mg | — | 12/222 (5.4%) | 137/222 (61.7%) |
| Tanezumab 10 mg | — | 20/226 (8.8%) | 153/226 (67.7%) |
| Event | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| OsteonecrosisMusculoskeletal and connective tissue disorders | 1/230 | 4/222 | 4/226 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/230 | 1/222 | 4/226 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/230 | 1/222 | 3/226 |
| Small intestinal obstructionGastrointestinal disorders | 0/230 | 1/222 | 1/226 |
| CellulitisInfections and infestations | 1/230 | 1/222 | 1/226 |
| Joint dislocationInjury, poisoning and procedural complications | 0/230 | 1/222 | 0/226 |
| Back painMusculoskeletal and connective tissue disorders | 1/230 | 1/222 | 0/226 |
| Fracture malunionMusculoskeletal and connective tissue disorders | 0/230 | 1/222 | 0/226 |
| Neck painMusculoskeletal and connective tissue disorders | 0/230 | 1/222 | 0/226 |
| Acute generalised exanthematous pustulosisSkin and subcutaneous tissue disorders | 0/230 | 1/222 | 0/226 |
| Event | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 35/230 | 30/222 | 26/226 |
| ParaesthesiaNervous system disorders | 13/230 | 17/222 | 25/226 |
| Oedema peripheralGeneral disorders | 9/230 | 16/222 | 22/226 |
| Injection site reactionGeneral disorders | 19/230 | 21/222 | 20/226 |
| Urinary tract infectionInfections and infestations | 11/230 | 12/222 | 20/226 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 6/230 | 11/222 | 16/226 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 14/230 | 12/222 | 16/226 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 8/230 | 15/222 | 12/226 |
| HypoaesthesiaNervous system disorders | 14/230 | 6/222 | 15/226 |
| Joint swellingMusculoskeletal and connective tissue disorders | 8/230 | 10/222 | 13/226 |
Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
| Age, Customized(Participants) | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg | Total |
|---|---|---|---|---|
| 18 to 44 years | 11 | 7 | 4 | 22 |
| 45 to 64 years | 128 | 124 | 113 | 365 |
| Greater than or equal to (>=) 65 years | 91 | 91 | 109 | 291 |
| Sex: Female, Male(Participants) | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg | Total |
|---|---|---|---|---|
| Female | 152 | 157 | 161 | 470 |
| Male | 78 | 65 | 65 | 208 |
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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