| 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. | 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). | Posted | | Count of Participants | | Participants | | Baseline up to 112 days after last dose of study treatment (up to 448 days) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| AEs | | | | SAEs | | |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 32 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 32 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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). | Data was not collected at Week 56 since efficacy assessment was not required after clinical hold. | Posted | | | | | | A4091012: Baseline, A4091039: Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Tanezumab 20 mg | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 32 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | Data was not collected at Week 56 since efficacy assessment was not required after clinical hold. | Posted | | | | | | A4091012: Baseline, A4091039: Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Tanezumab 20 mg |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 32 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | Data was not collected at Week 56 since efficacy assessment was not required after clinical hold. | Posted | | | | | | A4091012: Baseline, A4091039: Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 32 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | A4091012: Baseline, A4091039: Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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). | Data was not collected at Week 56 since efficacy assessment was not required after clinical hold. | Posted | | | | | | A4091012: Baseline, A4091039: Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Time to Discontinuation Due to Lack of Efficacy | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). | Posted | | Median | Full Range | days | | Baseline up to Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Plasma Concentration of Tanezumab | Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero. | 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. | Posted | | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | | Baseline (Day 1), Week 8, 24, 40, 56, 64 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Total Nerve Growth Factor (NGF) Concentration | | 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. | Posted | | Mean | Standard Deviation | picogram/milliliter | | Baseline (Day 1), Week 8, 24, 40, 56, 64 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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). | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). | Posted | | Count of Participants | | Participants | | Baseline up to Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | percentage of impairment | | A4091012: Baseline, A4091039: Week 24, 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline (Day 1), Week 8, 24, 40, 56, 64 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline (Day 1), Week 4, 8, 16, 24, 32 for intravenous infusion; Week 24, 32, 40, 56, 64 for subcutaneous injection | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). | Posted | | Count of Participants | | Participants | | Day 1 up to Week 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|