Low Back Pain
Conditions
Keywords
low back pain monoclonal antibody nerve growth factor
Brief summary
The purpose of this study is to investigate the safety and efficacy of tanezumab for chronic low back pain. Patients who were randomized and treated with study medication in a previous chronic low back pain parent study will be eligible to enroll in this safety extension study at the Preferred Rollover Time Point visit or at the Early Termination visit of the parent study upon discontinuation due to lack of efficacy.
Detailed description
This study was terminated on 30 November 2010 following a US FDA clinical hold for tanezumab chronic low back pain clinical studies which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.
Interventions
BIOLOGICALTanezumab 20 mg
Tanezumab 20 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks
BIOLOGICALTanezumab 10 mg
Tanezumab 10 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent prior to completing any of the study procedures. * Female patients must meet one of the following criteria: 1\) Female patients of non childbearing potential - Must be post menopausal, defined as women who are \>=45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle Stimulating Hormone (FSH) level greater than 30 IU/L at Screening for the parent double blind CLBP study; or Must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy. 2.) Female patients of child bearing potential: must not be pregnant or lactating, and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method), and must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing * Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential. * Females of child bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the last dose of IV study medication. * Patient must be able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures * Patient has been treated in a parent tanezumab double blind CLBP study * Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP parent study or has been withdrawn for lack of efficacy. At least eight weeks but no more than 12 weeks have elapsed since the last study medication infusion in the parent study. Patients are permitted to enter the extension study up to 12 weeks after their last dose of study medication in their parent study (or 4 weeks after the End of Treatment visit)
Exclusion criteria
* Failed screening in a parent tanezumab double blind CLBP study * Withdrawn from a parent tanezumab double blind CLBP study for an adverse event * Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to become pregnant during the course of clinical study * Use of any investigational medication within 30 days prior to Baseline (3 months for any investigational biological other than tanezumab) or plans to receive an investigational medication other than the study medication during the course of this study * Patients who exited the parent double blind CLBP study because of lack of compliance, protocol violation (including not meeting entrance criteria), no longer willing to participate (for reasons other than lack of efficacy), or were lost to follow up in the parent double blind study * Patients who were randomized into the parent study in violation of inclusion or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 56 | A4091012: Baseline, A4091039: Week 56 | Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). |
| Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 56 | A4091012: Baseline, A4091039: Week 56 | RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability. |
| Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4 | A4091012: Baseline, A4091039: Week 4 | Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). |
| Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8 | A4091012: Baseline, A4091039: Week 8 | Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). |
| Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16 | A4091012: Baseline, A4091039: Week 16 | Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). |
| Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24 | A4091012: Baseline, A4091039: Week 24 | Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). |
| Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32 | A4091012: Baseline, A4091039: Week 32 | Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). |
| Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40 | A4091012: Baseline, A4091039: Week 40 | Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). |
| Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48 | A4091012: Baseline, A4091039: Week 48 | Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 112 days after last dose of study treatment (up to 448 days) | AE: any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE: AE resulting in any of 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 medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | A4091012: Baseline, A4091039: Week 4 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8 | A4091012: Baseline, A4091039: Week 8 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16 | A4091012: Baseline, A4091039: Week 16 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24 | A4091012: Baseline, A4091039: Week 24 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32 | A4091012: Baseline, A4091039: Week 32 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40 | A4091012: Baseline, A4091039: Week 40 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48 | A4091012: Baseline, A4091039: Week 48 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56 | A4091012: Baseline, A4091039: Week 56 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | A4091012: Baseline, A4091039: Week 4 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 | A4091012: Baseline, A4091039: Week 8 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 | A4091012: Baseline, A4091039: Week 16 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 | A4091012: Baseline, A4091039: Week 24 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 | A4091012: Baseline, A4091039: Week 32 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 | A4091012: Baseline, A4091039: Week 40 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 | A4091012: Baseline, A4091039: Week 48 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56 | A4091012: Baseline, A4091039: Week 56 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | A4091012: Baseline, A4091039: Week 4 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | A4091012: Baseline, A4091039: Week 8 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | A4091012: Baseline, A4091039: Week 16 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | A4091012: Baseline, A4091039: Week 24 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | A4091012: Baseline, A4091039: Week 32 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | A4091012: Baseline, A4091039: Week 40 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 | A4091012: Baseline, A4091039: Week 48 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 56 | A4091012: Baseline, A4091039: Week 56 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment. |
| Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4 | A4091012: Baseline, A4091039: Week 4 | RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability. |
| Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8 | A4091012: Baseline, A4091039: Week 8 | RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability. |
| Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16 | A4091012: Baseline, A4091039: Week 16 | RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability. |
| Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24 | A4091012: Baseline, A4091039: Week 24 | RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability. |
| Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32 | A4091012: Baseline, A4091039: Week 32 | RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability. |
| Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40 | A4091012: Baseline, A4091039: Week 40 | RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability. |
| Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48 | A4091012: Baseline, A4091039: Week 48 | RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of Tanezumab | Baseline (Day 1), Week 8, 24, 40, 56, 64 | Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero. |
| Total Nerve Growth Factor (NGF) Concentration | Baseline (Day 1), Week 8, 24, 40, 56, 64 | — |
| Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 56 | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Day 1 up to Week 56 | Number of participants are reported based on the maximum number of intravenous (IV) and subcutaneous (SC) doses of tanezumab received. |
| Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | A4091012: Baseline, A4091039: Week 24, 56 | WPAI:SHP: 6-item, binary question on current employment, 3 questions on hours of work and work-loss, 2 questions based on 0-10 point scale to judge how CLBP affects ability to work, perform regular activities(0=no effect on work/activity, 10=completely prevented from working/activity). Four scores derived as percent: activity impairment, impairment while working, overall work impairment, work time missed. Total possible score: 0-100 (0=no impairment/high productivity, 100=completely impaired/low activity). Each of 4 scores expressed as impairment percentages, high percentage=more impairment, less productivity. |
| Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP) | Baseline up to Week 56 | Food and Drug Administration (FDA) approved analgesics and muscle relaxants were permitted as concomitant medications for CLBP and were prescribed as per investigator's discretion. These medications included opioids, topical analgesics, non-steroidal anti-inflammatory drug (NSAIDs), capsaicin products, oral/injectable corticosteroids, and viscosupplementation (eg, hyaluronan). |
| Number of Participants Who Developed Anti-Tanezumab Antibodies | Baseline (Day 1), Week 8, 24, 40, 56, 64 | Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point. |
| Number of Participants With Injection and Infusion Site Reactions | Baseline (Day 1), Week 4, 8, 16, 24, 32 for intravenous infusion; Week 24, 32, 40, 56, 64 for subcutaneous injection | The injection and infusion site reactions were assessed based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after administration (not related to needle insertion pain) of subcutaneous injection or intravenous infusion. |
Countries
United States
Participant flow
Recruitment details
Participants who received study drug in parent study A4091012 (NCT00876187) were eligible to be enrolled in this study, either at preferred rollover visit(Day 113) or due to early discontinuation in parent study for lack of efficacy. Dosing interval between last dose in parent study and first dose in this study was not less than 8 weeks and not more than 12 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Tanezumab 10 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 10 milligram (mg) intravenous (IV) infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 3 tanezumab 10 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 10 mg subcutaneous (SC) injections at 8-week interval. | 321 |
| Tanezumab 20 mg Participants who had previously received either tanezumab (RN624 or PF-04383119) 5, 20 mg IV infusion every 8 weeks along with placebo matched to naproxen 500 mg tablet orally twice daily; or placebo matched to tanezumab IV infusion every 8 weeks along with either naproxen 500 mg tablet or matching placebo orally twice daily in parent study A4091012 (NCT00876187), received a maximum of 5 tanezumab 20 mg IV infusions over 5 minutes at 8-week interval, followed by a maximum of 3 tanezumab 20 mg SC injections at 8-week interval. | 527 |
| Total | 848 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 23 | 39 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Lack of Efficacy | 10 | 15 |
| Overall Study | Lost to Follow-up | 10 | 12 |
| Overall Study | Other | 29 | 52 |
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | Protocol Violation | 2 | 5 |
| Overall Study | Randomized but not Treated | 1 | 0 |
| Overall Study | Study terminated by sponsor | 199 | 330 |
| Overall Study | Withdrawal by Subject | 47 | 71 |
Baseline characteristics
| Characteristic | Tanezumab 10 mg | Tanezumab 20 mg | Total |
|---|---|---|---|
| Age, Customized 18 to 44 years | 79 Participants | 128 Participants | 207 Participants |
| Age, Customized 45 to 64 years | 182 Participants | 300 Participants | 482 Participants |
| Age, Customized Greater than (>) 64 years | 60 Participants | 99 Participants | 159 Participants |
| Sex: Female, Male Female | 167 Participants | 277 Participants | 444 Participants |
| Sex: Female, Male Male | 154 Participants | 250 Participants | 404 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 152 / 321 | 277 / 527 |
| serious Total, serious adverse events | 15 / 321 | 24 / 527 |
Outcome results
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16
BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 16
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | Change at Week 16: Walking Ability | -2.55 units on a scale | Standard Deviation 2.76 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | Change at Week 16: Sleep | -3.19 units on a scale | Standard Deviation 2.93 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | Change at Week 16: Normal Work | -2.83 units on a scale | Standard Deviation 2.61 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | Change at Week 16: Composite score | -2.76 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | Change at Week 16: General Activity | -3.20 units on a scale | Standard Deviation 2.81 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | Change at Week 16: Composite score | -3.05 units on a scale | Standard Deviation 2.51 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | Change at Week 16: General Activity | -3.26 units on a scale | Standard Deviation 2.89 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | Change at Week 16: Walking Ability | -2.94 units on a scale | Standard Deviation 2.93 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | Change at Week 16: Normal Work | -3.26 units on a scale | Standard Deviation 2.84 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | Change at Week 16: Sleep | -3.34 units on a scale | Standard Deviation 2.94 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24
BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 24
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | Change at Week 24: Walking Ability | -2.70 units on a scale | Standard Deviation 2.84 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | Change at Week 24: Sleep | -3.47 units on a scale | Standard Deviation 2.91 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | Change at Week 24: Normal Work | -3.06 units on a scale | Standard Deviation 2.8 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | Change at Week 24: Composite score | -2.90 units on a scale | Standard Deviation 2.52 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | Change at Week 24: General Activity | -3.12 units on a scale | Standard Deviation 2.87 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | Change at Week 24: Normal Work | -3.25 units on a scale | Standard Deviation 2.77 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | Change at Week 24: Composite score | -3.03 units on a scale | Standard Deviation 2.5 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | Change at Week 24: Walking Ability | -2.90 units on a scale | Standard Deviation 2.81 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | Change at Week 24: General Activity | -3.25 units on a scale | Standard Deviation 2.95 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24 | Change at Week 24: Sleep | -3.42 units on a scale | Standard Deviation 2.96 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32
BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 32
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | Change at Week 32: Walking Ability | -2.32 units on a scale | Standard Deviation 3.26 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | Change at Week 32: Sleep | -3.10 units on a scale | Standard Deviation 3.22 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | Change at Week 32: Normal Work | -2.74 units on a scale | Standard Deviation 3.31 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | Change at Week 32: Composite score | -2.52 units on a scale | Standard Deviation 3.09 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | Change at Week 32: General Activity | -2.47 units on a scale | Standard Deviation 3.21 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | Change at Week 32: Composite score | -2.94 units on a scale | Standard Deviation 2.32 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | Change at Week 32: General Activity | -3.17 units on a scale | Standard Deviation 2.67 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | Change at Week 32: Walking Ability | -2.74 units on a scale | Standard Deviation 2.78 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | Change at Week 32: Normal Work | -3.20 units on a scale | Standard Deviation 2.65 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32 | Change at Week 32: Sleep | -3.47 units on a scale | Standard Deviation 2.91 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4
BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 4
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Change at Week 4: Sleep | -3.53 units on a scale | Standard Deviation 3.13 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Baseline: Composite score | 5.36 units on a scale | Standard Deviation 2.11 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Change at Week 4: Walking Ability | -2.85 units on a scale | Standard Deviation 2.88 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Change at Week 4: Normal Work | -3.15 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Change at Week 4: Composite score | -3.09 units on a scale | Standard Deviation 2.52 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Baseline: General Activity | 5.91 units on a scale | Standard Deviation 2.08 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Baseline: Walking Ability | 5.22 units on a scale | Standard Deviation 2.5 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Baseline: Normal Work | 5.74 units on a scale | Standard Deviation 2.18 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Baseline: Sleep | 5.97 units on a scale | Standard Deviation 2.61 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Change at Week 4: General Activity | -3.39 units on a scale | Standard Deviation 2.76 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Baseline: Normal Work | 5.94 units on a scale | Standard Deviation 2.11 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Baseline: Sleep | 5.86 units on a scale | Standard Deviation 2.5 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Change at Week 4: Composite score | -3.21 units on a scale | Standard Deviation 2.45 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Baseline: Composite score | 5.37 units on a scale | Standard Deviation 1.91 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Change at Week 4: General Activity | -3.45 units on a scale | Standard Deviation 2.81 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Baseline: Walking Ability | 5.40 units on a scale | Standard Deviation 2.34 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Change at Week 4: Walking Ability | -3.15 units on a scale | Standard Deviation 2.85 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Baseline: General Activity | 5.87 units on a scale | Standard Deviation 2.1 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Change at Week 4: Normal Work | -3.49 units on a scale | Standard Deviation 2.8 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | Change at Week 4: Sleep | -3.45 units on a scale | Standard Deviation 2.98 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40
BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 40
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | Change at Week 40: Composite score | -2.27 units on a scale | Standard Deviation 3.18 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | Change at Week 40: General Activity | -2.88 units on a scale | Standard Deviation 3.04 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | Change at Week 40: Walking Ability | -2.13 units on a scale | Standard Deviation 2.53 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | Change at Week 40: Normal Work | -2.63 units on a scale | Standard Deviation 3.38 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | Change at Week 40: Sleep | -3.13 units on a scale | Standard Deviation 3.72 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | Change at Week 40: Sleep | -3.41 units on a scale | Standard Deviation 2.62 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | Change at Week 40: Normal Work | -2.73 units on a scale | Standard Deviation 2.36 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | Change at Week 40: General Activity | -2.46 units on a scale | Standard Deviation 2.55 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | Change at Week 40: Composite score | -2.72 units on a scale | Standard Deviation 2.28 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40 | Change at Week 40: Walking Ability | -2.59 units on a scale | Standard Deviation 2.73 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48
BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 48
Population: ITT analysis set. 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 48 since none of the participants received dosing beyond Week 32 and efficacy assessment was not required after clinical hold.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 | Change at Week 48: General Activity | -1.71 units on a scale | Standard Deviation 2.21 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 | Change at Week 48: Walking Ability | -1.71 units on a scale | Standard Deviation 2.21 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 | Change at Week 48: Normal Work | -1.57 units on a scale | Standard Deviation 1.99 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 | Change at Week 48: Sleep | -2.43 units on a scale | Standard Deviation 1.13 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48 | Change at Week 48: Composite score | -1.76 units on a scale | Standard Deviation 1.53 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 56
BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 56
Population: Data was not collected at Week 56 since efficacy assessment was not required after clinical hold.
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8
BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 8
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | Change at Week 8: Walking Ability | -2.58 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | Change at Week 8: Sleep | -3.15 units on a scale | Standard Deviation 3.06 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | Change at Week 8: Normal Work | -2.77 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | Change at Week 8: Composite score | -2.74 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | Change at Week 8: General Activity | -2.99 units on a scale | Standard Deviation 2.65 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | Change at Week 8: Composite score | -3.09 units on a scale | Standard Deviation 2.52 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | Change at Week 8: General Activity | -3.36 units on a scale | Standard Deviation 2.88 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | Change at Week 8: Walking Ability | -3.00 units on a scale | Standard Deviation 2.89 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | Change at Week 8: Normal Work | -3.32 units on a scale | Standard Deviation 2.9 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | Change at Week 8: Sleep | -3.34 units on a scale | Standard Deviation 2.96 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16
BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: A4091012: Baseline, A4091039: Week 16
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 | Change at Week 16: Worst Pain | -3.30 units on a scale | Standard Deviation 2.83 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 | Change at Week 16: Average Pain | -3.00 units on a scale | Standard Deviation 2.41 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 | Change at Week 16: Pain right now | -3.42 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 | Change at Week 16: Least Pain | -2.75 units on a scale | Standard Deviation 2.42 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 | Change at Week 16: Average Pain | -3.34 units on a scale | Standard Deviation 2.38 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 | Change at Week 16: Worst Pain | -3.58 units on a scale | Standard Deviation 2.72 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 | Change at Week 16: Least Pain | -2.73 units on a scale | Standard Deviation 2.4 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 | Change at Week 16: Pain right now | -3.68 units on a scale | Standard Deviation 2.67 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24
BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: A4091012: Baseline, A4091039: Week 24
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 | Change at Week 24: Worst Pain | -3.45 units on a scale | Standard Deviation 2.8 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 | Change at Week 24: Average Pain | -3.14 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 | Change at Week 24: Least Pain | -2.79 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 | Change at Week 24: Pain right now | -3.50 units on a scale | Standard Deviation 2.8 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 | Change at Week 24: Pain right now | -3.59 units on a scale | Standard Deviation 2.66 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 | Change at Week 24: Worst Pain | -3.55 units on a scale | Standard Deviation 2.74 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 | Change at Week 24: Least Pain | -2.63 units on a scale | Standard Deviation 2.34 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 | Change at Week 24: Average Pain | -3.31 units on a scale | Standard Deviation 2.29 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32
BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: A4091012: Baseline, A4091039: Week 32
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 | Change at Week 32: Least Pain | -2.50 units on a scale | Standard Deviation 2.88 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 | Change at Week 32: Worst Pain | -3.26 units on a scale | Standard Deviation 2.9 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 | Change at Week 32: Average Pain | -2.82 units on a scale | Standard Deviation 2.63 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 | Change at Week 32: Pain right now | -3.35 units on a scale | Standard Deviation 2.96 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 | Change at Week 32: Pain right now | -3.77 units on a scale | Standard Deviation 2.43 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 | Change at Week 32: Average Pain | -3.23 units on a scale | Standard Deviation 2.18 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 | Change at Week 32: Worst Pain | -3.80 units on a scale | Standard Deviation 2.61 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 | Change at Week 32: Least Pain | -2.68 units on a scale | Standard Deviation 2.35 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4
BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: A4091012: Baseline, A4091039: Week 4
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Baseline: Worst Pain | 7.09 units on a scale | Standard Deviation 1.56 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Baseline: Average Pain | 6.13 units on a scale | Standard Deviation 1.51 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Change at Week 4: Worst Pain | -3.68 units on a scale | Standard Deviation 2.65 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Change at Week 4: Average Pain | -3.22 units on a scale | Standard Deviation 2.39 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Change at Week 4: Pain right now | -3.70 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Baseline: Least Pain | 5.02 units on a scale | Standard Deviation 2.09 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Baseline: Pain right now | 6.22 units on a scale | Standard Deviation 2.01 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Change at Week 4: Least Pain | -2.88 units on a scale | Standard Deviation 2.51 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Change at Week 4: Worst Pain | -3.97 units on a scale | Standard Deviation 2.81 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Baseline: Least Pain | 4.95 units on a scale | Standard Deviation 2.02 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Baseline: Average Pain | 6.25 units on a scale | Standard Deviation 1.43 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Change at Week 4: Least Pain | -2.93 units on a scale | Standard Deviation 2.43 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Change at Week 4: Average Pain | -3.45 units on a scale | Standard Deviation 2.38 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Baseline: Pain right now | 6.22 units on a scale | Standard Deviation 1.93 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Change at Week 4: Pain right now | -3.86 units on a scale | Standard Deviation 2.73 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | Baseline: Worst Pain | 7.29 units on a scale | Standard Deviation 1.53 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40
BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: A4091012: Baseline, A4091039: Week 40
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 | Change at Week 40: Worst Pain | -3.88 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 | Change at Week 40: Least Pain | -2.75 units on a scale | Standard Deviation 2.76 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 | Change at Week 40: Average Pain | -2.75 units on a scale | Standard Deviation 3.01 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 | Change at Week 40: Pain right now | -3.13 units on a scale | Standard Deviation 3.6 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 | Change at Week 40: Pain right now | -3.57 units on a scale | Standard Deviation 2.44 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 | Change at Week 40: Worst Pain | -3.49 units on a scale | Standard Deviation 2.67 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 | Change at Week 40: Least Pain | -2.43 units on a scale | Standard Deviation 1.91 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 | Change at Week 40: Average Pain | -2.97 units on a scale | Standard Deviation 2.28 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48
BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: A4091012: Baseline, A4091039: Week 48
Population: ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 48 since none of the participants received dosing beyond Week 32 and efficacy assessment was not required after clinical hold.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 | Change at Week 48: Least Pain | -0.86 units on a scale | Standard Deviation 1.95 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 | Change at Week 48: Average Pain | -2.14 units on a scale | Standard Deviation 2.12 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 | Change at Week 48: Pain right now | -2.00 units on a scale | Standard Deviation 2.38 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 | Change at Week 48: Worst Pain | -2.43 units on a scale | Standard Deviation 2.44 |
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56
BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: A4091012: Baseline, A4091039: Week 56
Population: Data was not collected at Week 56 since efficacy assessment was not required after clinical hold.
Primary
Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8
BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).
Time frame: A4091012: Baseline, A4091039: Week 8
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 | Change at Week 8: Worst Pain | -3.20 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 | Change at Week 8: Least Pain | -2.65 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 | Change at Week 8: Average Pain | -2.92 units on a scale | Standard Deviation 2.3 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 | Change at Week 8: Pain right now | -3.27 units on a scale | Standard Deviation 2.71 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 | Change at Week 8: Average Pain | -3.36 units on a scale | Standard Deviation 2.36 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 | Change at Week 8: Pain right now | -3.63 units on a scale | Standard Deviation 2.78 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 | Change at Week 8: Least Pain | -2.83 units on a scale | Standard Deviation 2.44 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 | Change at Week 8: Worst Pain | -3.68 units on a scale | Standard Deviation 2.75 |
Primary
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 16
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16 | 0.39 units on a scale | Standard Deviation 1.6 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16 | 0.42 units on a scale | Standard Deviation 1.75 |
Primary
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 24
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24 | 0.35 units on a scale | Standard Deviation 1.65 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24 | 0.46 units on a scale | Standard Deviation 1.93 |
Primary
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 32
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32 | 0.36 units on a scale | Standard Deviation 1.54 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32 | 0.32 units on a scale | Standard Deviation 1.47 |
Primary
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 4
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | Baseline | 0.89 units on a scale | Standard Deviation 2.53 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | Change at Week 4 | 0.34 units on a scale | Standard Deviation 1.37 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | Change at Week 4 | 0.54 units on a scale | Standard Deviation 2.12 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | Baseline | 1.14 units on a scale | Standard Deviation 2.81 |
Primary
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 40
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40 | 0.55 units on a scale | Standard Deviation 1.69 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40 | 0.26 units on a scale | Standard Deviation 1.52 |
Primary
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 48
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48 | 0.75 units on a scale | Standard Deviation 2.19 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48 | 0.18 units on a scale | Standard Deviation 1.2 |
Primary
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 56
Population: ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 56 since none of the participants received dosing beyond Week 32 and safety assessment was only required for 16 weeks after treatment discontinuation due to clinical hold.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56 | 0.70 units on a scale | Standard Deviation 2.36 |
Primary
Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
Time frame: A4091012: Baseline, A4091039: Week 8
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8 | 0.42 units on a scale | Standard Deviation 1.72 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8 | 0.54 units on a scale | Standard Deviation 1.84 |
Primary
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16
Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).
Time frame: A4091012: Baseline, A4091039: Week 16
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16 | -1.05 units on a scale | Standard Deviation 1.02 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16 | -1.03 units on a scale | Standard Deviation 0.96 |
Primary
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24
Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).
Time frame: A4091012: Baseline, A4091039: Week 24
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24 | -1.09 units on a scale | Standard Deviation 0.95 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24 | -1.05 units on a scale | Standard Deviation 1.01 |
Primary
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32
Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).
Time frame: A4091012: Baseline, A4091039: Week 32
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32 | -1.07 units on a scale | Standard Deviation 1.14 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32 | -1.05 units on a scale | Standard Deviation 0.98 |
Primary
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4
Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).
Time frame: A4091012: Baseline, A4091039: Week 4
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4 | Baseline | 3.38 units on a scale | Standard Deviation 0.57 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4 | Change at Week 4 | -1.17 units on a scale | Standard Deviation 1 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4 | Baseline | 3.36 units on a scale | Standard Deviation 0.56 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4 | Change at Week 4 | -1.21 units on a scale | Standard Deviation 1 |
Primary
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40
Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).
Time frame: A4091012: Baseline, A4091039: Week 40
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40 | -1.25 units on a scale | Standard Deviation 1.04 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40 | -0.95 units on a scale | Standard Deviation 1.03 |
Primary
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48
Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).
Time frame: A4091012: Baseline, A4091039: Week 48
Population: ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 48 since none of the participants received dosing beyond Week 32 and efficacy assessment was not required after clinical hold.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48 | -0.43 units on a scale | Standard Deviation 0.79 |
Primary
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 56
Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).
Time frame: A4091012: Baseline, A4091039: Week 56
Population: Data was not collected at Week 56 since efficacy assessment was not required after clinical hold.
Primary
Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8
Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).
Time frame: A4091012: Baseline, A4091039: Week 8
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8 | -0.97 units on a scale | Standard Deviation 0.97 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8 | -1.07 units on a scale | Standard Deviation 1.01 |
Primary
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16
RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.
Time frame: A4091012: Baseline, A4091039: Week 16
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16 | -4.90 units on a scale | Standard Deviation 5.84 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16 | -5.19 units on a scale | Standard Deviation 5.36 |
Primary
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24
RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.
Time frame: A4091012: Baseline, A4091039: Week 24
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24 | -4.79 units on a scale | Standard Deviation 5.64 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24 | -5.30 units on a scale | Standard Deviation 5.61 |
Primary
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32
RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.
Time frame: A4091012: Baseline, A4091039: Week 32
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32 | -5.36 units on a scale | Standard Deviation 5.87 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32 | -5.07 units on a scale | Standard Deviation 5.46 |
Primary
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4
RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.
Time frame: A4091012: Baseline, A4091039: Week 4
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4 | Baseline | 13.01 units on a scale | Standard Deviation 5.13 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4 | Change at Week 4 | -5.52 units on a scale | Standard Deviation 5.73 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4 | Baseline | 12.66 units on a scale | Standard Deviation 4.85 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4 | Change at Week 4 | -5.35 units on a scale | Standard Deviation 5.47 |
Primary
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40
RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.
Time frame: A4091012: Baseline, A4091039: Week 40
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40 | -6.00 units on a scale | Standard Deviation 6.32 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40 | -4.13 units on a scale | Standard Deviation 6.32 |
Primary
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48
RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.
Time frame: A4091012: Baseline, A4091039: Week 48
Population: ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 48 since none of the participants received dosing beyond Week 32 and efficacy assessment was not required after clinical hold.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48 | -2.67 units on a scale | Standard Deviation 6.02 |
Primary
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 56
RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.
Time frame: A4091012: Baseline, A4091039: Week 56
Population: Data was not collected at Week 56 since efficacy assessment was not required after clinical hold.
Primary
Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8
RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.
Time frame: A4091012: Baseline, A4091039: Week 8
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8 | -4.86 units on a scale | Standard Deviation 5.14 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8 | -5.02 units on a scale | Standard Deviation 5.71 |
Primary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE: AE resulting in any of 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 medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state.
Time frame: Baseline up to 112 days after last dose of study treatment (up to 448 days)
Population: Intent-to-treat (ITT) analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 10 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 15 Participants |
| Tanezumab 10 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 198 Participants |
| Tanezumab 20 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 370 Participants |
| Tanezumab 20 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 24 Participants |
Secondary
Plasma Concentration of Tanezumab
Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.
Time frame: Baseline (Day 1), Week 8, 24, 40, 56, 64
Population: Pharmacokinetic(PK) analysis set: participants who received at least 1 dose of IV or SC study medication during this study, A4091039(NCT00924664), had at least 1 plasma concentration value above LLOQ. 'Overall Number of Participants Analyzed' signifies participants evaluable for this measure, 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively. Due to clinical hold, study was terminated prematurely, data was not collected at Week 64.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Week 8 | 596.957 nanogram/milliliter (ng/mL) | Standard Deviation 533.8274 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Week 40 | 542.571 nanogram/milliliter (ng/mL) | Standard Deviation 240.5285 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Week 24 | 588.216 nanogram/milliliter (ng/mL) | Standard Deviation 296.7509 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Week 56 | 250.512 nanogram/milliliter (ng/mL) | Standard Deviation 393.9501 |
| Tanezumab 10 mg | Plasma Concentration of Tanezumab | Baseline | 393.519 nanogram/milliliter (ng/mL) | Standard Deviation 659.815 |
| Tanezumab 20 mg | Plasma Concentration of Tanezumab | Week 56 | 502.320 nanogram/milliliter (ng/mL) | Standard Deviation 676.1049 |
| Tanezumab 20 mg | Plasma Concentration of Tanezumab | Baseline | 427.871 nanogram/milliliter (ng/mL) | Standard Deviation 771.2499 |
| Tanezumab 20 mg | Plasma Concentration of Tanezumab | Week 8 | 1074.76 nanogram/milliliter (ng/mL) | Standard Deviation 527.5588 |
| Tanezumab 20 mg | Plasma Concentration of Tanezumab | Week 24 | 1276.75 nanogram/milliliter (ng/mL) | Standard Deviation 770.0278 |
| Tanezumab 20 mg | Plasma Concentration of Tanezumab | Week 40 | 1058.92 nanogram/milliliter (ng/mL) | Standard Deviation 666.4789 |
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 56
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tanezumab 10 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
| Tanezumab 20 mg | Time to Discontinuation Due to Lack of Efficacy | NA days |
Secondary
Total Nerve Growth Factor (NGF) Concentration
Time frame: Baseline (Day 1), Week 8, 24, 40, 56, 64
Population: ITT analysis set. 'Overall number of participants analyzed' signifies participants evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively. Data was not collected at Week 64 since assessment was only required for 16 weeks after treatment discontinuation due to clinical hold.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Baseline | 2599.9 picogram/milliliter | Standard Deviation 1893.7 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Week 24 | 4132.7 picogram/milliliter | Standard Deviation 1780.1 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Week 8 | 3771.1 picogram/milliliter | Standard Deviation 1472.3 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Week 40 | 4314.0 picogram/milliliter | Standard Deviation 1372.4 |
| Tanezumab 10 mg | Total Nerve Growth Factor (NGF) Concentration | Week 56 | 2855.5 picogram/milliliter | Standard Deviation 1651.8 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Week 8 | 4470.2 picogram/milliliter | Standard Deviation 1773.6 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Week 40 | 4446.7 picogram/milliliter | Standard Deviation 1807.1 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Baseline | 2025.4 picogram/milliliter | Standard Deviation 2281.4 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Week 56 | 3639.3 picogram/milliliter | Standard Deviation 1990.3 |
| Tanezumab 20 mg | Total Nerve Growth Factor (NGF) Concentration | Week 24 | 4860.6 picogram/milliliter | Standard Deviation 1990.6 |
Other Pre-specified
Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56
WPAI:SHP: 6-item, binary question on current employment, 3 questions on hours of work and work-loss, 2 questions based on 0-10 point scale to judge how CLBP affects ability to work, perform regular activities(0=no effect on work/activity, 10=completely prevented from working/activity). Four scores derived as percent: activity impairment, impairment while working, overall work impairment, work time missed. Total possible score: 0-100 (0=no impairment/high productivity, 100=completely impaired/low activity). Each of 4 scores expressed as impairment percentages, high percentage=more impairment, less productivity.
Time frame: A4091012: Baseline, A4091039: Week 24, 56
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 24:impairment during work | -26.30 percentage of impairment | Standard Deviation 24.79 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Baseline:activity impairment | 58.19 percentage of impairment | Standard Deviation 23.05 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 24:overall impairment | -4.63 percentage of impairment | Standard Deviation 23.62 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Baseline:work time missed | 2.99 percentage of impairment | Standard Deviation 10.81 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 24:work time missed | -1.49 percentage of impairment | Standard Deviation 10.33 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Baseline:overall impairment | 8.23 percentage of impairment | Standard Deviation 23.11 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 24:activity impairment | -25.29 percentage of impairment | Standard Deviation 27.64 |
| Tanezumab 10 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Baseline:impairment during work | 48.77 percentage of impairment | Standard Deviation 23.56 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 24:overall impairment | -3.25 percentage of impairment | Standard Deviation 21.39 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 24:work time missed | -0.50 percentage of impairment | Standard Deviation 8.24 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 56:activity impairment | -8.00 percentage of impairment | Standard Deviation 34.58 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 56:overall impairment | 1.75 percentage of impairment | Standard Deviation 16.76 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 56:impairment during work | -10.00 percentage of impairment | Standard Deviation 28.28 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Baseline:activity impairment | 58.74 percentage of impairment | Standard Deviation 21.24 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Baseline:impairment during work | 47.98 percentage of impairment | Standard Deviation 23.66 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Baseline:overall impairment | 7.46 percentage of impairment | Standard Deviation 21.97 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 56:work time missed | 1.41 percentage of impairment | Standard Deviation 4.71 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Baseline:work time missed | 2.27 percentage of impairment | Standard Deviation 8.67 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 24:activity impairment | -26.34 percentage of impairment | Standard Deviation 28.55 |
| Tanezumab 20 mg | Change From A4091012 (NCT00876187) Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 24 and 56 | Change at Week 24:impairment during work | -21.36 percentage of impairment | Standard Deviation 26.84 |
Other Pre-specified
Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP)
Food and Drug Administration (FDA) approved analgesics and muscle relaxants were permitted as concomitant medications for CLBP and were prescribed as per investigator's discretion. These medications included opioids, topical analgesics, non-steroidal anti-inflammatory drug (NSAIDs), capsaicin products, oral/injectable corticosteroids, and viscosupplementation (eg, hyaluronan).
Time frame: Baseline up to Week 56
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 10 mg | Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP) | 150 Participants |
| Tanezumab 20 mg | Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP) | 268 Participants |
Other Pre-specified
Number of Participants Who Developed Anti-Tanezumab Antibodies
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.
Time frame: Baseline (Day 1), Week 8, 24, 40, 56, 64
Population: ITT analysis set. 'Overall number of participants analyzed'=participants evaluable for this measure at any time point. 'Number Analyzed' signifies participants evaluated at specific time points for each arm, respectively. Data was not analyzed at Week 64 since safety assessment was only required for 16 weeks after treatment discontinuation due to clinical hold.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 10 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 8 | 4 Participants |
| Tanezumab 10 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 40 | 0 Participants |
| Tanezumab 10 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 24 | 3 Participants |
| Tanezumab 10 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 56 | 1 Participants |
| Tanezumab 10 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Baseline | 1 Participants |
| Tanezumab 20 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 56 | 1 Participants |
| Tanezumab 20 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Baseline | 0 Participants |
| Tanezumab 20 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 8 | 1 Participants |
| Tanezumab 20 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 24 | 1 Participants |
| Tanezumab 20 mg | Number of Participants Who Developed Anti-Tanezumab Antibodies | Week 40 | 0 Participants |
Other Pre-specified
Number of Participants With Injection and Infusion Site Reactions
The injection and infusion site reactions were assessed based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after administration (not related to needle insertion pain) of subcutaneous injection or intravenous infusion.
Time frame: Baseline (Day 1), Week 4, 8, 16, 24, 32 for intravenous infusion; Week 24, 32, 40, 56, 64 for subcutaneous injection
Population: ITT analysis set. Data was not analyzed at Week 64 for SC injection since safety assessment was only required for 16 weeks after treatment discontinuation due to clinical hold.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 10 mg | Number of Participants With Injection and Infusion Site Reactions | Baseline: Infusion site | 7 Participants |
| Tanezumab 10 mg | Number of Participants With Injection and Infusion Site Reactions | Week 4: Infusion site | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Injection and Infusion Site Reactions | Week 8: Infusion site | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Injection and Infusion Site Reactions | Week 16: Infusion site | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Injection and Infusion Site Reactions | Week 24: Infusion site | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Injection and Infusion Site Reactions | Week 32: Infusion site | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Injection and Infusion Site Reactions | Week 24: Injection site | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Injection and Infusion Site Reactions | Week 32: Injection site | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Injection and Infusion Site Reactions | Week 40: Injection site | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Injection and Infusion Site Reactions | Week 56: Injection site | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Injection and Infusion Site Reactions | Week 32: Injection site | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Injection and Infusion Site Reactions | Baseline: Infusion site | 7 Participants |
| Tanezumab 20 mg | Number of Participants With Injection and Infusion Site Reactions | Week 32: Infusion site | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Injection and Infusion Site Reactions | Week 4: Infusion site | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Injection and Infusion Site Reactions | Week 56: Injection site | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Injection and Infusion Site Reactions | Week 8: Infusion site | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Injection and Infusion Site Reactions | Week 24: Injection site | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Injection and Infusion Site Reactions | Week 16: Infusion site | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Injection and Infusion Site Reactions | Week 40: Injection site | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Injection and Infusion Site Reactions | Week 24: Infusion site | 0 Participants |
Other Pre-specified
Number of Participants With Intravenous and Subcutaneous Doses of Study Medication
Number of participants are reported based on the maximum number of intravenous (IV) and subcutaneous (SC) doses of tanezumab received.
Time frame: Day 1 up to Week 56
Population: ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 10 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of IV Doses: 1 | 59 Participants |
| Tanezumab 10 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of IV Doses: 2 | 93 Participants |
| Tanezumab 10 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of IV Doses: 3 | 169 Participants |
| Tanezumab 10 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of IV Doses: 4 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of IV Doses: 5 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of SC Doses: 1 | 71 Participants |
| Tanezumab 10 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of SC Doses: 2 | 8 Participants |
| Tanezumab 10 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of SC Doses: 3 | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of SC Doses: 3 | 7 Participants |
| Tanezumab 20 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of IV Doses: 1 | 102 Participants |
| Tanezumab 20 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of IV Doses: 5 | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of IV Doses: 2 | 145 Participants |
| Tanezumab 20 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of SC Doses: 2 | 42 Participants |
| Tanezumab 20 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of IV Doses: 3 | 276 Participants |
| Tanezumab 20 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of SC Doses: 1 | 111 Participants |
| Tanezumab 20 mg | Number of Participants With Intravenous and Subcutaneous Doses of Study Medication | Number of IV Doses: 4 | 3 Participants |