Trial Outcomes & Findings for RN624 In Adult Patients With Chronic Low Back Pain (NCT NCT00584870)

NCT ID: NCT00584870

Last Updated: 2021-07-12

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

220 participants

Primary outcome timeframe

Baseline, Week 6

Results posted on

2021-07-12

Participant Flow

Participants underwent a 5-day initial pain assessment period prior to study treatment.

Participant milestones

Participant milestones
Measure	Tanezumab Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Overall Study STARTED	88	89	43
Overall Study Treated	88	88	41
Overall Study COMPLETED	59	64	25
Overall Study NOT COMPLETED	29	25	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Tanezumab Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Overall Study Adverse Event	4	3	2
Overall Study Lost to Follow-up	4	1	1
Overall Study Lack of Efficacy	7	14	8
Overall Study Withdrawal by Subject	10	5	3
Overall Study Protocol Violation	1	1	2
Overall Study Did not met entrance criteria	1	0	0
Overall Study Other	2	0	0
Overall Study Randomized but not treated	0	1	2

Baseline Characteristics

RN624 In Adult Patients With Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Total n=217 Participants Total of all reporting groups
Age, Continuous	49.5 years STANDARD_DEVIATION 14.7 • n=93 Participants	52.1 years STANDARD_DEVIATION 14.8 • n=4 Participants	52.2 years STANDARD_DEVIATION 15 • n=27 Participants	51.1 years STANDARD_DEVIATION 14.8 • n=483 Participants
Sex: Female, Male Female	53 Participants n=93 Participants	42 Participants n=4 Participants	23 Participants n=27 Participants	118 Participants n=483 Participants
Sex: Female, Male Male	35 Participants n=93 Participants	46 Participants n=4 Participants	18 Participants n=27 Participants	99 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies participants who were evaluable for this measure at given time points.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 Change at Week 6	-3.58 units on a scale Standard Deviation 1.87	-2.69 units on a scale Standard Deviation 1.98	-2.16 units on a scale Standard Deviation 2.24
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 Baseline	6.48 units on a scale Standard Deviation 1.42	6.65 units on a scale Standard Deviation 1.44	6.67 units on a scale Standard Deviation 1.44

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12

Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=87 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=40 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 Change at Week 4	-3.39 units on a scale Standard Deviation 1.83	-2.57 units on a scale Standard Deviation 1.86	-2.23 units on a scale Standard Deviation 2.07
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 Change at Week 8	-3.74 units on a scale Standard Deviation 1.88	-2.79 units on a scale Standard Deviation 2.06	-2.48 units on a scale Standard Deviation 2.09
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 Change at Week 12	-3.45 units on a scale Standard Deviation 2.08	-2.88 units on a scale Standard Deviation 2.24	-2.68 units on a scale Standard Deviation 2.40
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 Change at Week 1	-2.41 units on a scale Standard Deviation 1.69	-2.18 units on a scale Standard Deviation 1.81	-1.34 units on a scale Standard Deviation 1.52
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 Change at Week 2	-2.25 units on a scale Standard Deviation 2.04	-2.40 units on a scale Standard Deviation 1.83	-1.92 units on a scale Standard Deviation 1.87

SECONDARY outcome

Timeframe: Baseline, Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12) values minus the baseline value.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=87 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 Change over Weeks 1 to 4	-2.59 units on a scale Standard Deviation 1.75	-2.35 units on a scale Standard Deviation 1.73	-1.83 units on a scale Standard Deviation 1.71
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 Change over Weeks 1 to 8	-2.86 units on a scale Standard Deviation 1.81	-2.47 units on a scale Standard Deviation 1.75	-1.97 units on a scale Standard Deviation 1.80
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 Change over Weeks 1 to 12	-2.92 units on a scale Standard Deviation 1.85	-2.52 units on a scale Standard Deviation 1.80	-2.06 units on a scale Standard Deviation 1.84
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 Change over Weeks 5 to 8	-3.56 units on a scale Standard Deviation 1.91	-2.66 units on a scale Standard Deviation 1.89	-2.38 units on a scale Standard Deviation 2.07
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 Change over Weeks 5 to 12	-3.48 units on a scale Standard Deviation 1.94	-2.68 units on a scale Standard Deviation 1.94	-2.46 units on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 6, 8, 12

Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points.

The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions (Q) 1-4 assessed the magnitude of pain (Q1 for worst pain, Q2 for least pain, Q3 for average pain, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain. Question 5 consisted of 7 sub-items (A to G; general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain score, each ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 1: Average Pain	-2.09 units on a scale Standard Deviation 2.07	-2.02 units on a scale Standard Deviation 1.77	-1.46 units on a scale Standard Deviation 1.95
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 2: Worst Pain	-2.21 units on a scale Standard Deviation 2.53	-2.67 units on a scale Standard Deviation 2.24	-2.28 units on a scale Standard Deviation 2.25
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 2: Average Pain	-1.97 units on a scale Standard Deviation 2.01	-2.20 units on a scale Standard Deviation 1.82	-2.22 units on a scale Standard Deviation 2.22
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 4: Worst Pain	-3.54 units on a scale Standard Deviation 2.17	-2.57 units on a scale Standard Deviation 2.29	-2.47 units on a scale Standard Deviation 3.25
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Baseline: Worst Pain	6.89 units on a scale Standard Deviation 1.69	7.02 units on a scale Standard Deviation 1.74	7.29 units on a scale Standard Deviation 1.65
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Baseline: Average Pain	5.99 units on a scale Standard Deviation 1.43	6.18 units on a scale Standard Deviation 1.42	6.54 units on a scale Standard Deviation 1.64
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 1: Worst Pain	-2.54 units on a scale Standard Deviation 2.33	-2.40 units on a scale Standard Deviation 2.02	-1.88 units on a scale Standard Deviation 2.38
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 4: Average Pain	-2.99 units on a scale Standard Deviation 1.91	-2.37 units on a scale Standard Deviation 1.87	-2.61 units on a scale Standard Deviation 2.56
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 6: Worst Pain	-3.67 units on a scale Standard Deviation 2.45	-2.87 units on a scale Standard Deviation 2.34	-2.29 units on a scale Standard Deviation 3.30
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 6: Average Pain	-3.29 units on a scale Standard Deviation 1.85	-2.45 units on a scale Standard Deviation 1.98	-2.65 units on a scale Standard Deviation 2.39
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 8: Worst Pain	-3.85 units on a scale Standard Deviation 2.37	-2.89 units on a scale Standard Deviation 2.56	-2.90 units on a scale Standard Deviation 2.77
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 8: Average Pain	-3.26 units on a scale Standard Deviation 1.89	-2.44 units on a scale Standard Deviation 2.03	-2.80 units on a scale Standard Deviation 2.30
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 12: Worst Pain	-3.40 units on a scale Standard Deviation 2.37	-2.93 units on a scale Standard Deviation 2.66	-2.83 units on a scale Standard Deviation 3.17
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 Change at Week 12: Average Pain	-3.00 units on a scale Standard Deviation 1.92	-2.45 units on a scale Standard Deviation 2.36	-2.88 units on a scale Standard Deviation 2.47

SECONDARY outcome

Timeframe: Week 1, 2, 4, 6, 8, 12

Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Last observation carried forward (LOCF) method was used to impute missing values.

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants were classified as responders if average LBPI score was 2 or less, and as non-responders if average LBPI score was greater than (\>) 2. Participants with average LBPI score of 2 or less were reported.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less Week 1	18 Participants	13 Participants	2 Participants
Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less Week 2	20 Participants	19 Participants	4 Participants
Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less Week 4	27 Participants	19 Participants	6 Participants
Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less Week 6	33 Participants	21 Participants	5 Participants
Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less Week 8	32 Participants	25 Participants	8 Participants
Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less Week 12	26 Participants	21 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 6

Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). LOCF method was used to impute missing values.

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with cumulative reduction (as percent) (greater than 0% ; \>= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in Average LBPI score from Baseline at Week 6 were reported, participants (%) are reported more than once in categories specified.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 Greater than 0% reduction	79 Participants	77 Participants	34 Participants
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 Greater than or equal to (>=)10% reduction	75 Participants	72 Participants	29 Participants
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 >=20% reduction	68 Participants	64 Participants	21 Participants
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 >=30% reduction	65 Participants	50 Participants	13 Participants
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 >=40% reduction	58 Participants	41 Participants	12 Participants
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 >=50% reduction	50 Participants	30 Participants	8 Participants
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 >=60% reduction	40 Participants	26 Participants	7 Participants
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 >=70% reduction	25 Participants	16 Participants	5 Participants
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 >=80% reduction	16 Participants	9 Participants	3 Participants
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 >=90% reduction	10 Participants	5 Participants	1 Participants
Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 100% reduction	6 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12

Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here '"overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants with \>=30% or \>=50% reduction from baseline in daily average LBPI score that was maintained for a minimum duration of 4 consecutive days were reported.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=87 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score >=30% reduction	71 Participants	60 Participants	26 Participants
Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score >=50% reduction	62 Participants	50 Participants	20 Participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 6, 8, 12

Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). LOCF method was used to impute missing values.

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with \>=30% and \>=50% reduction from Baseline in daily average LBPI score were reported.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 8: >=30% reduction	66 Participants	51 Participants	18 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 1: >=30% reduction	46 Participants	45 Participants	8 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 1: >=50% reduction	28 Participants	26 Participants	5 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 2: >=30% reduction	42 Participants	48 Participants	14 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 2: >=50% reduction	28 Participants	31 Participants	7 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 4: >=30% reduction	62 Participants	50 Participants	16 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 4: >=50% reduction	43 Participants	28 Participants	10 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 6: >=30% reduction	65 Participants	50 Participants	13 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 6: >=50% reduction	50 Participants	30 Participants	8 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 8: >=50% reduction	49 Participants	33 Participants	9 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 12: >=30% reduction	59 Participants	45 Participants	20 Participants
Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Week 12: >=50% reduction	43 Participants	30 Participants	12 Participants

SECONDARY outcome

Timeframe: Randomization to Last Study Visit (up to 16 weeks)

Time to achieve \>=30% or \>=50% sustained reduction from baseline (i.e. reduction from baseline in daily average LBPI score that was maintained for a total of 4 consecutive days) was summarized using the Kaplan-Meier estimates of the median time to 30% and 50% response. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=87 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Time to >=30% reduction	8 days Interval 2.0 to 69.0	7 days Interval 2.0 to 39.0	17 days Interval 2.0 to 49.0
Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Time to >=50% reduction	18 days Interval 2.0 to 64.0	41 days Interval 2.0 to 61.0	65 days Interval 2.0 to 102.0

SECONDARY outcome

Timeframe: Week 1 up to Week 12

Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion).

Total duration of response was defined as the total number of days with \>=30% or \>=50% reduction from baseline in the daily average LBPI score. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Total duration for >=30% reduction	43.91 days Standard Error 3.54	38.81 days Standard Error 3.59	33.13 days Standard Error 4.82
Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score Total duration for >=50% reduction	33.21 days Standard Error 3.30	27.58 days Standard Error 3.34	22.08 days Standard Error 4.49

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 6, 8, 12

Population: ITT population. Here "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points.

Roland-Morris Disability Questionnaire: low back pain-specific, participant administered questionnaire that assessed how well participants with low back pain were able to function with regard to daily activities. The questionnaire consisted of 24 statements and the participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. The number of statements marked were added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability.

Outcome measures

Outcome measures
Measure	Tanezumab n=87 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 Change at Week 1	-5.21 units on a scale Standard Deviation 5.24	-3.69 units on a scale Standard Deviation 5.11	-3.76 units on a scale Standard Deviation 5.25
Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 Change at Week 2	-5.17 units on a scale Standard Deviation 5.59	-4.04 units on a scale Standard Deviation 5.37	-4.08 units on a scale Standard Deviation 6.25
Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 Baseline	12.33 units on a scale Standard Deviation 4.63	12.36 units on a scale Standard Deviation 4.80	13.68 units on a scale Standard Deviation 5.17
Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 Change at Week 4	-7.24 units on a scale Standard Deviation 5.33	-4.00 units on a scale Standard Deviation 4.99	-4.31 units on a scale Standard Deviation 5.81
Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 Change at Week 6	-7.88 units on a scale Standard Deviation 5.39	-4.69 units on a scale Standard Deviation 5.34	-4.55 units on a scale Standard Deviation 6.55
Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 Change at Week 8	-7.93 units on a scale Standard Deviation 4.97	-5.17 units on a scale Standard Deviation 5.32	-5.60 units on a scale Standard Deviation 6.22
Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 Change at Week 12	-7.12 units on a scale Standard Deviation 6.00	-5.10 units on a scale Standard Deviation 5.50	-4.67 units on a scale Standard Deviation 6.84

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 6, 8, 12

Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points.

The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1 to 4 assessed the magnitude of pain (worst, least, average, right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 consisted of 7 sub-items (general activity \[GA\], mood, walking ability \[WA\], normal work \[NW\], relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (did not interfere) to 10 (completely interfere). The response from 7 sub-items of question 5 were averaged to obtain pain interference composite score (CS), range: 0 to 10 (higher score=more interference).

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 1: Sleep	-2.73 units on a scale Standard Deviation 2.52	-2.87 units on a scale Standard Deviation 3.02	-2.27 units on a scale Standard Deviation 2.53
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 2: WA	-1.87 units on a scale Standard Deviation 2.94	-2.48 units on a scale Standard Deviation 2.79	-2.64 units on a scale Standard Deviation 3.16
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 4: CS	-3.13 units on a scale Standard Deviation 2.01	-2.52 units on a scale Standard Deviation 2.35	-2.72 units on a scale Standard Deviation 2.80
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 4: Sleep	-3.54 units on a scale Standard Deviation 2.51	-2.63 units on a scale Standard Deviation 3.20	-3.08 units on a scale Standard Deviation 2.90
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 6: NW	-3.55 units on a scale Standard Deviation 2.04	-2.95 units on a scale Standard Deviation 2.74	-2.87 units on a scale Standard Deviation 3.12
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 8: GA	-3.72 units on a scale Standard Deviation 2.22	-3.14 units on a scale Standard Deviation 2.78	-2.93 units on a scale Standard Deviation 3.27
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 8: NW	-3.62 units on a scale Standard Deviation 2.08	-3.24 units on a scale Standard Deviation 2.59	-3.33 units on a scale Standard Deviation 3.13
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 12: WA	-2.78 units on a scale Standard Deviation 2.71	-2.54 units on a scale Standard Deviation 2.87	-2.04 units on a scale Standard Deviation 3.48
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 12: NW	-3.36 units on a scale Standard Deviation 2.43	-2.97 units on a scale Standard Deviation 2.63	-3.17 units on a scale Standard Deviation 3.29
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Baseline: CS	4.81 units on a scale Standard Deviation 2.19	5.43 units on a scale Standard Deviation 2.14	5.29 units on a scale Standard Deviation 2.25
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Baseline: GA	5.55 units on a scale Standard Deviation 2.26	5.83 units on a scale Standard Deviation 2.25	5.49 units on a scale Standard Deviation 2.72
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Baseline: WA	4.46 units on a scale Standard Deviation 2.80	5.25 units on a scale Standard Deviation 2.66	5.15 units on a scale Standard Deviation 2.81
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Baseline: NW	5.15 units on a scale Standard Deviation 2.48	5.89 units on a scale Standard Deviation 2.38	5.80 units on a scale Standard Deviation 2.39
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Baseline: Sleep	5.69 units on a scale Standard Deviation 2.70	5.75 units on a scale Standard Deviation 2.69	6.20 units on a scale Standard Deviation 2.44
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 1: CS	-2.52 units on a scale Standard Deviation 2.13	-2.51 units on a scale Standard Deviation 2.46	-2.07 units on a scale Standard Deviation 2.17
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 1: GA	-3.10 units on a scale Standard Deviation 2.63	-2.51 units on a scale Standard Deviation 2.82	-1.88 units on a scale Standard Deviation 2.47
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 1: WA	-2.35 units on a scale Standard Deviation 2.64	-2.04 units on a scale Standard Deviation 2.96	-2.17 units on a scale Standard Deviation 2.94
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 1: NW	-2.75 units on a scale Standard Deviation 2.41	-2.40 units on a scale Standard Deviation 2.84	-2.22 units on a scale Standard Deviation 2.75
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 2: CS	-2.17 units on a scale Standard Deviation 2.13	-2.82 units on a scale Standard Deviation 2.41	-2.70 units on a scale Standard Deviation 2.71
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 2: GA	-2.61 units on a scale Standard Deviation 2.58	-2.94 units on a scale Standard Deviation 2.84	-2.58 units on a scale Standard Deviation 3.54
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 2: NW	-2.45 units on a scale Standard Deviation 2.55	-3.02 units on a scale Standard Deviation 2.61	-2.92 units on a scale Standard Deviation 3.08
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 2: Sleep	-2.41 units on a scale Standard Deviation 2.49	-2.88 units on a scale Standard Deviation 2.70	-3.19 units on a scale Standard Deviation 2.88
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 4: GA	-3.62 units on a scale Standard Deviation 2.29	-2.58 units on a scale Standard Deviation 2.72	-2.36 units on a scale Standard Deviation 3.87
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 4: WA	-2.87 units on a scale Standard Deviation 2.50	-2.09 units on a scale Standard Deviation 2.72	-2.81 units on a scale Standard Deviation 3.04
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 4: NW	-3.55 units on a scale Standard Deviation 2.36	-2.63 units on a scale Standard Deviation 2.65	-2.81 units on a scale Standard Deviation 3.25
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 6: CS	-3.25 units on a scale Standard Deviation 1.85	-2.84 units on a scale Standard Deviation 2.29	-2.76 units on a scale Standard Deviation 2.61
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 6: GA	-3.65 units on a scale Standard Deviation 2.12	-2.97 units on a scale Standard Deviation 2.66	-2.68 units on a scale Standard Deviation 3.07
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 6: WA	-3.11 units on a scale Standard Deviation 2.55	-2.48 units on a scale Standard Deviation 2.86	-2.39 units on a scale Standard Deviation 2.84
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 6: Sleep	-3.92 units on a scale Standard Deviation 2.54	-2.99 units on a scale Standard Deviation 2.95	-3.03 units on a scale Standard Deviation 2.58
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 8: CS	-3.19 units on a scale Standard Deviation 1.84	-3.01 units on a scale Standard Deviation 2.31	-3.04 units on a scale Standard Deviation 2.73
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 8: WA	-3.05 units on a scale Standard Deviation 2.56	-2.62 units on a scale Standard Deviation 3.04	-2.87 units on a scale Standard Deviation 3.07
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 8: Sleep	-3.47 units on a scale Standard Deviation 2.45	-3.51 units on a scale Standard Deviation 2.93	-3.33 units on a scale Standard Deviation 2.80
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 12: CS	-3.08 units on a scale Standard Deviation 2.01	-2.84 units on a scale Standard Deviation 2.34	-2.74 units on a scale Standard Deviation 3.15
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 12: GA	-3.45 units on a scale Standard Deviation 2.42	-3.01 units on a scale Standard Deviation 2.93	-2.92 units on a scale Standard Deviation 3.79
Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 Change at Week 12: Sleep	-3.58 units on a scale Standard Deviation 2.44	-3.33 units on a scale Standard Deviation 2.87	-3.08 units on a scale Standard Deviation 2.80

SECONDARY outcome

Timeframe: Week 1, 2, 4, 6, 8, 12

Patient's global assessment of low back pain scale assessed participants overall impression of disease activity. Participants answered: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded using a 5-point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor). Participants who reported a change of -4, -3, -2, -1, 0, 1, 2, 3, 4 from Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) score at specified weeks were presented.

Outcome measures

Outcome measures
Measure	Tanezumab n=77 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=84 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 4: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 1: Change= -1	23 Participants	33 Participants	14 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 1: Change= 0	25 Participants	26 Participants	17 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 1: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 2: Change= -4	1 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 4: Change= -4	1 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 4: Change= -3	0 Participants	2 Participants	5 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 4: Change= -1	30 Participants	32 Participants	15 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 4: Change= 2	0 Participants	2 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 4: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 6: Change= -4	2 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 6: Change= -1	20 Participants	18 Participants	12 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 6: Change= 2	0 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 6: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 8: Change= -4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 8: Change= -3	2 Participants	5 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 8: Change= 0	11 Participants	19 Participants	4 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 8: Change= 2	0 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 8: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 8: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 12: Change= -4	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 12: Change= -3	1 Participants	6 Participants	4 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 12: Change= -1	22 Participants	21 Participants	9 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 12: Change= 0	20 Participants	14 Participants	7 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 12: Change= 2	0 Participants	0 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 8: Change= -1	23 Participants	25 Participants	14 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 8: Change= 1	1 Participants	4 Participants	4 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 12: Change= 1	1 Participants	11 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 1: Change= -4	1 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 1: Change= -3	1 Participants	2 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 1: Change= -2	24 Participants	18 Participants	6 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 1: Change= 1	2 Participants	4 Participants	3 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 1: Change= 2	1 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 1: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 2: Change= -3	2 Participants	4 Participants	4 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 2: Change= -2	16 Participants	17 Participants	5 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 2: Change= -1	26 Participants	30 Participants	17 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 2: Change= 0	24 Participants	23 Participants	8 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 2: Change= 1	6 Participants	6 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 2: Change= 2	1 Participants	1 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 2: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 2: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 4: Change= -2	22 Participants	18 Participants	6 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 12: Change= -2	14 Participants	15 Participants	2 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 12: Change= 3	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 12: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 4: Change= 0	14 Participants	20 Participants	7 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 4: Change= 1	0 Participants	4 Participants	3 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 6: Change= -3	2 Participants	7 Participants	3 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 6: Change= -2	25 Participants	22 Participants	5 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 6: Change= 0	15 Participants	20 Participants	10 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 6: Change= 1	1 Participants	7 Participants	1 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 6: Change= 4	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 Week 8: Change= -2	23 Participants	17 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 6, 8, 12

Participants answered: "In all ways, how would you rate your overall response to the study medication today?" Participants responded using a 4-point Likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicated better overall response to the treatment.

Outcome measures

Outcome measures
Measure	Tanezumab n=78 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=84 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=40 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 1: Poor	7 Participants	13 Participants	12 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 1: Fair	16 Participants	22 Participants	11 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 2: Poor	10 Participants	16 Participants	6 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 4: Fair	5 Participants	16 Participants	10 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 4: Good	30 Participants	27 Participants	13 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 4: Excellent	29 Participants	21 Participants	5 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 6: Excellent	32 Participants	18 Participants	4 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 8: Good	20 Participants	19 Participants	13 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 12: Poor	6 Participants	15 Participants	6 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 1: Good	29 Participants	32 Participants	14 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 1: Excellent	26 Participants	17 Participants	3 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 2: Fair	17 Participants	14 Participants	11 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 2: Good	31 Participants	34 Participants	15 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 2: Excellent	19 Participants	18 Participants	4 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 4: Poor	4 Participants	15 Participants	8 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 6: Poor	1 Participants	11 Participants	8 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 6: Fair	10 Participants	23 Participants	5 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 6: Good	22 Participants	23 Participants	14 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 8: Poor	1 Participants	9 Participants	6 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 8: Fair	8 Participants	24 Participants	7 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 8: Excellent	32 Participants	19 Participants	4 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 12: Fair	9 Participants	17 Participants	6 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 12: Good	21 Participants	18 Participants	5 Participants
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication Week 12: Excellent	23 Participants	17 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion).

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants Who Discontinued the Study Due to Lack of Efficacy	7 Participants	14 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion).

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. Median was not estimable if the percentage of participants who discontinued due to lack of efficacy was below 50%.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Time to Discontinuation Due to Lack of Efficacy	NA days Interval 8.0 to 49.0 Median was not evaluable since very low number of participants discontinued due to lack of efficacy.	NA days Interval 9.0 to 71.0 Median was not evaluable since very low number of participants discontinued due to lack of efficacy.	NA days Interval 6.0 to 57.0 Median was not evaluable since very low number of participants discontinued due to lack of efficacy.

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 6, 8, 12

Population: ITT population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). LOCF method was used to impute missing values. Here "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure

Participants were considered as CLBP responders if they had achieved a reduction of \>=30% in daily average LBPI score from baseline, an increase of \>=30% in patient's global assessment of low back pain (disease activity) from baseline, and no worsening (increase) in RMDQ total score from baseline at specified week. Daily average low back pain assessed on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Patient's global assessment of low back pain assessed using a 5-point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor). RMDQ: low back pain-specific, participant administered questionnaire consisted of 24 statements and participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. Total RMDQ score was calculated as sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability.

Outcome measures

Outcome measures
Measure	Tanezumab n=87 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants With Chronic Low Back Pain (CLBP) Response Week 2	32 Participants	34 Participants	9 Participants
Number of Participants With Chronic Low Back Pain (CLBP) Response Week 12	38 Participants	30 Participants	12 Participants
Number of Participants With Chronic Low Back Pain (CLBP) Response Week 1	33 Participants	30 Participants	6 Participants
Number of Participants With Chronic Low Back Pain (CLBP) Response Week 4	51 Participants	31 Participants	11 Participants
Number of Participants With Chronic Low Back Pain (CLBP) Response Week 6	50 Participants	39 Participants	9 Participants
Number of Participants With Chronic Low Back Pain (CLBP) Response Week 8	48 Participants	36 Participants	14 Participants

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Population: Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion). Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points.

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants Who Used Rescue Medications Week 2	65 Participants	49 Participants	27 Participants
Number of Participants Who Used Rescue Medications Week 3	54 Participants	42 Participants	24 Participants
Number of Participants Who Used Rescue Medications Week 6	36 Participants	42 Participants	20 Participants
Number of Participants Who Used Rescue Medications Week 7	34 Participants	38 Participants	17 Participants
Number of Participants Who Used Rescue Medications Week 8	31 Participants	39 Participants	19 Participants
Number of Participants Who Used Rescue Medications Week 1	61 Participants	50 Participants	29 Participants
Number of Participants Who Used Rescue Medications Week 4	40 Participants	49 Participants	28 Participants
Number of Participants Who Used Rescue Medications Week 5	37 Participants	46 Participants	21 Participants
Number of Participants Who Used Rescue Medications Week 9	33 Participants	38 Participants	12 Participants
Number of Participants Who Used Rescue Medications Week 10	30 Participants	41 Participants	14 Participants
Number of Participants Who Used Rescue Medications Week 11	32 Participants	31 Participants	13 Participants
Number of Participants Who Used Rescue Medications Week 12	30 Participants	33 Participants	16 Participants

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The number of days of rescue medication use during the particular week were summarized.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Duration of Rescue Medication Use Week 1	2 days Interval 0.0 to 6.0	1 days Interval 0.0 to 6.0	1 days Interval 0.0 to 6.0
Duration of Rescue Medication Use Week 2	2 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0	1.5 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 4	1 days Interval 0.0 to 7.0	2 days Interval 0.0 to 7.0	2 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 9	0.5 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0	0 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 3	2 days Interval 0.0 to 7.0	0.5 days Interval 0.0 to 7.0	2 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 5	0 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 6	0.5 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 7	0 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 8	0 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 10	0 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0	0 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 11	0.5 days Interval 0.0 to 7.0	0 days Interval 0.0 to 7.0	0 days Interval 0.0 to 7.0
Duration of Rescue Medication Use Week 12	0 days Interval 0.0 to 7.0	0 days Interval 0.0 to 7.0	1 days Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen (in mg) in each particular week was summarized.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Amount of Rescue Medication Taken Week 12	1828.1 mg Standard Deviation 2790.6	2253.5 mg Standard Deviation 3402.6	1722.2 mg Standard Deviation 2805.7
Amount of Rescue Medication Taken Week 1	2545.5 mg Standard Deviation 2798.4	2039.8 mg Standard Deviation 2467.3	2451.2 mg Standard Deviation 2816.9
Amount of Rescue Medication Taken Week 2	3221.6 mg Standard Deviation 3528.1	2327.6 mg Standard Deviation 3083.0	2225.0 mg Standard Deviation 2616.4
Amount of Rescue Medication Taken Week 3	2703.7 mg Standard Deviation 3368.8	2208.3 mg Standard Deviation 3112.6	2565.8 mg Standard Deviation 2719.2
Amount of Rescue Medication Taken Week 4	2220.8 mg Standard Deviation 3108.2	2475.0 mg Standard Deviation 2937.0	2434.2 mg Standard Deviation 2904.3
Amount of Rescue Medication Taken Week 5	2073.3 mg Standard Deviation 3100.5	2318.8 mg Standard Deviation 2936.3	2444.4 mg Standard Deviation 3285.9
Amount of Rescue Medication Taken Week 6	2062.5 mg Standard Deviation 2919.0	2227.3 mg Standard Deviation 3193.9	2573.5 mg Standard Deviation 3348.7
Amount of Rescue Medication Taken Week 7	1854.2 mg Standard Deviation 3126.9	1873.3 mg Standard Deviation 2763.3	2393.9 mg Standard Deviation 3149.3
Amount of Rescue Medication Taken Week 8	2134.3 mg Standard Deviation 3273.6	2212.3 mg Standard Deviation 3255.2	1924.2 mg Standard Deviation 2478.4
Amount of Rescue Medication Taken Week 9	1772.7 mg Standard Deviation 2627.1	2319.4 mg Standard Deviation 3483.7	1406.3 mg Standard Deviation 2554.1
Amount of Rescue Medication Taken Week 10	1851.6 mg Standard Deviation 2655.8	2513.9 mg Standard Deviation 3477.3	1534.5 mg Standard Deviation 2591.0
Amount of Rescue Medication Taken Week 11	1992.2 mg Standard Deviation 2717.5	2166.7 mg Standard Deviation 3632.8	1375.0 mg Standard Deviation 2311.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after last dose of study treatment (up to Week 16)

Population: Safety population included all randomized participants who received the Day 1 intravenous infusion (either tanezumab or placebo infusion).

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 Participants Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	50 Participants	54 Participants	27 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	0 Participants	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 12

Population: Safety population included all randomized participants who received the Day 1 intravenous infusion of tanezumab. Data for this outcome measure was not planned to be collected and analyzed for Naproxen and Placebo arms.

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).

Outcome measures

Outcome measures
Measure	Tanezumab n=88 Participants Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Number of Participants With Anti-Drug Antibody (ADA)	0 Participants	—	—

Adverse Events

Tanezumab

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Naproxen

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tanezumab n=88 participants at risk Single intravenous infusion of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.	Naproxen n=88 participants at risk Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with naproxen 500 milligram (mg) tablet orally twice daily up to Week 12.	Placebo n=41 participants at risk Single intravenous infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1) along with placebo matched to naproxen tablet orally twice daily up to Week 12.
Cardiac disorders Atrial fibrillation	0.00% 0/88 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/88 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/41 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope vasovagal	0.00% 0/88 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/88 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/41 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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