Long Term Safety Study of Tanezumab in Chronic Low Back Pain

NCT00924664 | Terminated Phase 2 Results DMC

• 2 other identifiers: A4091039CLBP SAFETY EXTENSION OF 1012
• Study Type: interventional
• Target: 849
• Locations: 1 country
• Sites: 149

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.

Conditions

Low Back Pain

Keywords

low back pain monoclonal antibody nerve growth factor

Outcome Measures

Primary Outcomes (41)

• 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.

  Baseline up to 112 days after last dose of study treatment (up to 448 days)

• 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.

  A4091012: Baseline, A4091039: Week 4

• 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.

  A4091012: Baseline, A4091039: Week 8

• 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.

  A4091012: Baseline, A4091039: Week 16

• 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.

  A4091012: Baseline, A4091039: Week 24

• 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.

  A4091012: Baseline, A4091039: Week 32

• 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.

  A4091012: Baseline, A4091039: Week 40

• 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.

  A4091012: Baseline, A4091039: Week 48

• 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.

  A4091012: Baseline, A4091039: Week 56

• 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).

  A4091012: Baseline, A4091039: Week 4

• 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).

  A4091012: Baseline, A4091039: Week 8

• 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).

  A4091012: Baseline, A4091039: Week 16

• 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).

  A4091012: Baseline, A4091039: Week 24

• 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).

  A4091012: Baseline, A4091039: Week 32

• 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).

  A4091012: Baseline, A4091039: Week 40

• 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).

  A4091012: Baseline, A4091039: Week 48

• 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).

  A4091012: Baseline, A4091039: Week 56

• 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.

  A4091012: Baseline, A4091039: Week 4

• 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.

  A4091012: Baseline, A4091039: Week 8

• 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.

  A4091012: Baseline, A4091039: Week 16

• 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.

  A4091012: Baseline, A4091039: Week 24

• 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.

  A4091012: Baseline, A4091039: Week 32

• 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.

  A4091012: Baseline, A4091039: Week 40

• 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.

  A4091012: Baseline, A4091039: Week 48

• 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.

  A4091012: Baseline, A4091039: Week 56

• 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.

  A4091012: Baseline, A4091039: Week 4

• 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.

  A4091012: Baseline, A4091039: Week 8

• 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.

  A4091012: Baseline, A4091039: Week 16

• 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.

  A4091012: Baseline, A4091039: Week 24

• 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.

  A4091012: Baseline, A4091039: Week 32

• 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.

  A4091012: Baseline, A4091039: Week 40

• 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.

  A4091012: Baseline, A4091039: Week 48

• 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.

  A4091012: Baseline, A4091039: Week 56

• 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).

  A4091012: Baseline, A4091039: Week 4

• 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).

  A4091012: Baseline, A4091039: Week 8

• 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).

  A4091012: Baseline, A4091039: Week 16

• 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).

  A4091012: Baseline, A4091039: Week 24

• 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).

  A4091012: Baseline, A4091039: Week 32

• 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).

  A4091012: Baseline, A4091039: Week 40

• 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).

  A4091012: Baseline, A4091039: Week 48

• 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).

  A4091012: Baseline, A4091039: Week 56

Secondary Outcomes (3)

• Time to Discontinuation Due to Lack of Efficacy

  Baseline up to Week 56

• Plasma Concentration of Tanezumab

  Baseline (Day 1), Week 8, 24, 40, 56, 64

• Total Nerve Growth Factor (NGF) Concentration

  Baseline (Day 1), Week 8, 24, 40, 56, 64

Other Outcomes (5)

• Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP)

  Baseline up to Week 56

• 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

• Number of Participants Who Developed Anti-Tanezumab Antibodies

  Baseline (Day 1), Week 8, 24, 40, 56, 64

Study Arms (2)

Tanezumab 20 mg

EXPERIMENTAL

Biological: Tanezumab 20 mg

Tanezumab 10 mg

EXPERIMENTAL

Biological: Tanezumab 10 mg

Interventions

Tanezumab 20 mg BIOLOGICAL

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

Tanezumab 20 mg

Tanezumab 10 mg BIOLOGICAL

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

Tanezumab 10 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent prior to completing any of the study procedures.
• Female patients must meet one of the following criteria:
• \) 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.
• ) 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)

You may not qualify if:

• 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
• Any other condition, which in the opinion of the Investigator, would put the patient at increased safety risk or otherwise make the patient unsuitable for this study

Sponsors & Collaborators

• Pfizer: lead

Study Sites (149)

Pinnacle Research Group, LLC

Anniston, Alabama, 36201, United States

Location

Pinnacle Research Group, Anniston Medical Clinic

Anniston, Alabama, 36207, United States

Location

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Simon Williamson Clinic, PC

Birmingham, Alabama, 35211, United States

Location

Simon-Williamson Clinic, PC

Hueytown, Alabama, 35023, United States

Location

Saadat Ansari, MD

Huntsville, Alabama, 35801, United States

Location

Alabama Orthopaedic Clinic

Mobile, Alabama, 36608, United States

Location

Horizon Research Group

Mobile, Alabama, 36608, United States

Location

Phoenix Diagnostic Imaging

Chandler, Arizona, 85224, United States

Location

Radiant Research - Phoenix Southeast

Chandler, Arizona, 85224, United States

Location

Simon Med

Mesa, Arizona, 85202, United States

Location

Pivotal Research Centers

Peoria, Arizona, 85381, United States

Location

Sun Radiology

Peoria, Arizona, 85381, United States

Location

Arizona Research Center, LLC

Phoenix, Arizona, 85023, United States

Location

Radiant Research

Scottsdale, Arizona, 85251, United States

Location

Scottsdale Medical Imaging

Scottsdale, Arizona, 85251, United States

Location

Premiere Phamaceutical Research, LLC

Tempe, Arizona, 85282, United States

Location

Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC

Tempe, Arizona, 85283, United States

Location

Little Rock Family Practice Clinic

Little Rock, Arkansas, 72205, United States

Location

Providence Clinical Research

Burbank, California, 91505, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Collaborative Neuroscience Network, Inc.

Garden Grove, California, 92845, United States

Location

University of California San Diego

La Jolla, California, 92121, United States

Location

Samaritan Center for Medical Research Medical Group

Los Gatos, California, 95032, United States

Location

Newport Diagnostic Center

Newport Beach, California, 92660, United States

Location

North County Clinical Research (NCCR)

Oceanside, California, 92056, United States

Location

Advances in Medicine

Rancho Mirage, California, 92270, United States

Location

Trinity Medical Research

Roseville, California, 95661, United States

Location

Center for Clinical Trials of Sacramento, Inc.

Sacramento, California, 95823, United States

Location

Wetlin Research Associates, Inc

San Diego, California, 92120, United States

Location

Inland Rheumatology & Osteoporosis Medical Group, Inc.

Upland, California, 91786, United States

Location

Elite Clinical Trials, Inc.

Wildomar, California, 92595, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80304, United States

Location

Clinicos, LLC

Colorado Springs, Colorado, 80904, United States

Location

Advanced Radiology

Stamford, Connecticut, 06902, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

New England Research Associates, LLC

Trumbull, Connecticut, 06611, United States

Location

Southeast Clinical Research, LLC

Chiefland, Florida, 32626, United States

Location

Southeast Clinical Research

Chiefland, Florida, 32626, United States

Location

Doctors Medical Center

DeFuniak Springs, Florida, 32435, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

SJS Clinical Research, Inc.

Destin, Florida, 32541, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Southeast Clinical Research, LLC

Jacksonville, Florida, 32216, United States

Location

Collier Neurologic Specialists

Naples, Florida, 34102, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Palm Beach Gardens Open Imaging Center

Palm Beach Gardens, Florida, 33410, United States

Location

University Clinical Research

Pembroke Pines, Florida, 33024, United States

Location

Advent Clinical Research Center

Pinellas Park, Florida, 33781, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

St Petersburg General Hospital - X-Rays only

St. Petersburg, Florida, 33710, United States

Location

Dale G. Bramlet, MD., P.L.

St. Petersburg, Florida, 33713, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33404, United States

Location

MD Now Urgent Care

West Palm Beach, Florida, 33409, United States

Location

Midtown Imaging

West Palm Beach, Florida, 33417, United States

Location

Center for Prospective Outcome Studies

Atlanta, Georgia, 30327, United States

Location

Southeastern Radiology Associates, LLC

Atlanta, Georgia, 30327, United States

Location

River Birch Research Alliance, LLC

Blue Ridge, Georgia, 30513, United States

Location

CT: Marietta Imaging Center LLC

Marietta, Georgia, 30060, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Selah Medical Center, PA

Boise, Idaho, 83704, United States

Location

Advanced Diagnostic Imaging (ADI)

Evansville, Indiana, 47714, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Diagnostic Imaging Centers

Overland Park, Kansas, 66211, United States

Location

Clinical Trials Technology, Inc.

Prairie Village, Kansas, 66206, United States

Location

Cotton-O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Cotton-O'Neil Clinic

Topeka, Kansas, 66606, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Commonwealth Biomedical Research

Madisonville, Kentucky, 42431, United States

Location

Arthritis and Diabetes Clinic

Monroe, Louisiana, 71203, United States

Location

Office of Peter A. Holt, MD

Baltimore, Maryland, 21239, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01610, United States

Location

The Center for Clinical Trials

Biloxi, Mississippi, 39531, United States

Location

Clinical Research Center of Jackson

Jackson, Mississippi, 39202, United States

Location

Physician's Surgery Center

Jackson, Mississippi, 39202, United States

Location

Clinvest, A Division of Banyan Group, Inc

Springfield, Missouri, 65807, United States

Location

Medex Healthcare Research, Inc.

St Louis, Missouri, 63117, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Clinical Research Consortium

Las Vegas, Nevada, 89119, United States

Location

Mirkil Medical

Las Vegas, Nevada, 89119, United States

Location

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

Booth Radiology

Stratford, New Jersey, 08084, United States

Location

CRI Worldwide, LLC

Willingboro, New Jersey, 08046, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Central New York Clinical Research

Manlius, New York, 13104, United States

Location

Medex Healthcare Research

New York, New York, 10004, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

B & I Imaging

Rochester, New York, 14609, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

Greensboro Imaging

Greensboro, North Carolina, 27407, United States

Location

Pharmquest

Greensboro, North Carolina, 27408, United States

Location

Caldwell Memorial Hospital

Lenoir, North Carolina, 28645, United States

Location

Northstate Clinical Research, PLLC

Lenoir, North Carolina, 28645, United States

Location

Wake Internal Medicine Consultants, Inc.

Raleigh, North Carolina, 27612, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Christine Codding, MD

Oklahoma City, Oklahoma, 73103, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

McBride Clinic, Inc

Oklahoma City, Oklahoma, 73103, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Medford Medical Clinic, LLP

Medford, Oregon, 95704, United States

Location

Rogue Valley Medical Center

Medford, Oregon, 97504, United States

Location

Sunstone Research

Medford, Oregon, 97504, United States

Location

Summit Research Network (Oregon), Inc.

Portland, Oregon, 97210, United States

Location

Allegheny Pain Management

Altoona, Pennsylvania, 16602, United States

Location

Blair Medical Associates-Radiology

Altoona, Pennsylvania, 16602, United States

Location

Paramount Clinical Research

Bridgeville, Pennsylvania, 15017, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

CRI Worldwide LLC

Philadelphia, Pennsylvania, 19139, United States

Location

New England Center for Clinical Research

Cranston, Rhode Island, 02920, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Columbia Arthritis Center, P.A.

Columbia, South Carolina, 29204, United States

Location

Southern Orthopaedic Sports Medicine

Columbia, South Carolina, 29204, United States

Location

Radiant Research

Greer, South Carolina, 29651, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

SCRI Research Center, LLC

Germantown, Tennessee, 38138, United States

Location

Wolf River Medical Group, LLC

Germantown, Tennessee, 38138, United States

Location

Advanced Therapeutics, Inc.

Johnson City, Tennessee, 37601, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

DiscoveResearch, Inc.

Beaumont, Texas, 77701, United States

Location

Beaumont Internal Medicine & Geriatric Associates

Beaumont, Texas, 77702, United States

Location

DiscoveResearch Incorporated

Bryan, Texas, 77802, United States

Location

Punzi Medical Center

Carrollton, Texas, 75006, United States

Location

KRK Medical Research

Dallas, Texas, 75230, United States

Location

Advances In Health, Inc.

Houston, Texas, 77030, United States

Location

St. Luke's Diagnostic & Treatment Center Kirby Glen

Houston, Texas, 77030, United States

Location

Centex Research Inc.

Houston, Texas, 77062, United States

Location

Centex Research

Houston, Texas, 77065, United States

Location

Centex Research

Nassau Bay, Texas, 77058, United States

Location

Paragon Research Center

San Antonio, Texas, 78205, United States

Location

Office of Theresia Lee, MD

San Antonio, Texas, 78229, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78229, United States

Location

Sendero Imaging and Treatment Center

San Antonio, Texas, 78229, United States

Location

J. Lewis Research, Inc.

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Incorporated/Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Chesapeake Regional Imaging Center-Kempsville

Norfolk, Virginia, 23502, United States

Location

Hampton Road Center for Clinical Research

Norfolk, Virginia, 23502, United States

Location

National Clinical Research - Richmond

Richmond, Virginia, 23294, United States

Location

Virginia Beach Radiology

Virginia Beach, Virginia, 23454-3033, United States

Location

Advanced Pain Management

Virginia Beach, Virginia, 23454, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Related Publications (2)

• Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.

  PMID: 26554876 DERIVED

• Gimbel JS, Kivitz AJ, Bramson C, Nemeth MA, Keller DS, Brown MT, West CR, Verburg KM. Long-term safety and effectiveness of tanezumab as treatment for chronic low back pain. Pain. 2014 Sep;155(9):1793-1801. doi: 10.1016/j.pain.2014.06.004. Epub 2014 Jun 14.

  PMID: 24937440 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Low Back Pain

Interventions

tanezumab

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to FDA-imposed clinical hold, further study drug dosing stopped prematurely and study was terminated. Designation of outcomes as primary, secondary based on study team input as study did not specify them as primary or secondary.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 19, 2009
• Study Start: August 20, 2009
• Primary Completion: November 30, 2010
• Study Completion: June 22, 2011
• Last Updated: April 21, 2021
• Results First Posted: April 21, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (149)