Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients
Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00960804
Collaborator
(none)
21
18
3
8.8
1.2
0.1
Study Details
Study Description
Brief Summary
Tanezumab, administered for up to 1 1/2 years, reduces the pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This study was terminated on 11 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Study Design
Study Type:
Interventional
Actual Enrollment
:
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, LONG-TERM SAFETY STUDY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Actual Study Start Date
:
Feb 15, 2010
Actual Primary Completion Date
:
Nov 11, 2010
Actual Study Completion Date
:
Nov 11, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tanezumab 5 mg
|
Biological: Tanezumab
IV, 5 mg dose, q 8 weeks, for up to 80 weeks
|
| Experimental: Tanezumab 10 mg
|
Biological: Tanezumab
IV, 10 mg dose, q 8 weeks, for up to 80 weeks
|
| Placebo Comparator: Placebo
|
Other: Placebo
IV, q 8 weeks, for up to 80 weeks
|
Outcome Measures
Primary Outcome Measures
- Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate and Heart Rate-Deep Breathing, Normal Deviate (5NC [nd] + HRdb-[nd]) Composite Score at Week 24 [A4091026: Baseline, A4091040: Week 24]
5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency [MNDL],peroneal nerve compound muscle action potential[CMAP],peroneal motor nerve conduction velocity[MNCV],tibial MNDL,sural sensory nerve action potential amplitude [SNAP])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score >0=worse response,less than(<)0=better response compared to normal matched population.Score change>0=worsening,<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values.
Secondary Outcome Measures
- Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) at Week 24 [A4091026: Baseline, A4091040: Week 24]
NIS-LL:assess muscle weakness, reflexes, sensation;scored separately for left, right limbs. 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);sensation (touch pressure,pin-prick,vibration,joint position) scored 0=normal,1=decreased, or 2=absent. NIS-LL score: sum of scores of NIS items 17-24, 28-29 and 34-37. Total possible NIS-LL score range 0-88,high score=more impairment.
- Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score (NIS) at Week 24 [A4091026: Baseline, A4091040: Week 24]
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
- Change From A4091026 (NCT00863772) Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24 [A4091026: Baseline, A4091040: Week 24]
NSC score is the number of the 38 symptom questions where the participants indicated experiencing the symptom to any severity. Total score range: 0 to 38 where higher score indicated more symptoms.
Other Outcome Measures
- Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 [A4091026: Baseline, A4091040: Week 24]
5NC (nd) score included five NCS attributes: peroneal MNDL, CMAP, MNCV; tibial MNDL; sural SNAP. Values of attributes scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as nd score based on standard normal distribution. For CMAP, MNCV, SNAP: score <0 indicated worse and >0 indicated better response; for peroneal,tibial MNDL: score >0 indicated worse and <0 indicated better response, as compared to normal matched population. For CMAP, MNCV, SNAP: score change <0 indicated worsening and >0 indicated improvement; for peroneal,tibial MNDL: score change >0 indicated worsening and <0 indicated improvement, as compared to baseline. Total score calculated as sum of each NCS attribute. Total score >0 indicated worse and <0 indicated better response as compared to normal matched population. Total score change >0 indicated worsening and <0 indicated improvement as compared to baseline.
- Change From A4091026 (NCT00863772) Baseline in Heart Rate-Deep Breathing, Normal Deviate (HRdb, [nd]) Score at Week 24 [A4091026: Baseline, A4091040: Week 24]
HRdb test was used to evaluate the effect of treatment on autonomic function. Participant took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as normal deviates. Score <0 indicated worse response and >0 indicated better response as compared to normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Measurements were collected twice and highest nd score was selected at each NV. Mean of the selected measurements was calculated to obtain Baseline and Week 24 values.
- Change From A4091026 (NCT00863772) Baseline in Intraepidermal Nerve Fiber Density (IENF) at Week 24 [A4091026: Baseline, A4091040: Week 24]
IENF density was quantified in 3 millimeter (mm) immunostained (PGP 9.5 immunohistochemical staining) skin punch biopsies taken from the distal end of the leg, 10 centimeter (cm) above the lateral malleolus, within the territory of the sural nerve, containing epidermis and superficial dermis to evaluate amount of small diameter nerve fibers. Skin biopsies were taken from normal appearing skin and skin having local scar, signs of trauma, ulceration, or active dermatologic process were avoided.
- Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 [A4091026: Baseline, A4091040: Week 8, 16, 24, 32]
WOMAC Index: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items), and physical function (17 items) in participants with osteoarthritis of the index hip or index knee. Each question was assessed on Numeric Rating Scale (NRS) as 0(none) to 10(extreme).Total possible domain score was calculated as the mean of the score for each domain questions. Score range:0-10,high scores=high pain/stiffness/difficulty in physical activity.
- Change From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 8, 16, 24 and 32 [A4091026: Baseline, A4091040: Week 8, 16, 24, 32]
PGA: Participants answered the following question: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants rated their condition using a 5-point Likert scale. Score range: 1 to 5. 1: Very Good (asymptomatic and no limitation of normal activities); 2: Good (mild symptoms and no limitation of normal activities); 3: Fair (moderate symptoms and limitation of some normal activites); 4: Poor (severe symptoms and inability to carry out most normal activities); 5: Very Poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
- Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response [Week 8, 16, 24]
OMERACT-OARSI response: >=50 percent (%) improvement from A4091026 (NCT00863772) baseline and absolute change from A4091026 (NCT00863772) baseline of >=2 units at week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: >=20% improvement from A4091026 (NCT00863772) baseline and absolute change from A4091026 (NCT00863772) baseline of >=1 unit at week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
- Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 8, 16 and 24 [A4091026: Baseline, A4091040: Week 8, 16, 24]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response. Change from baseline <0 indicates an improvement.
- Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score [Week 8, 16, 24, 32]
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.
- Percentage of Participants With Improvement of At Least 2 Points From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis [Week 8, 16, 24, 32]
PGA: Participants answered the following question: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants rated their condition using a 5-point Likert scale. Score range: 1 to 5. 1: Very Good (asymptomatic and no limitation of normal activities); 2: Good (mild symptoms and no limitation of normal activities); 3: Fair (moderate symptoms and limitation of some normal activites); 4: Poor (severe symptoms and inability to carry out most normal activities); 5: Very Poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
- Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 [A4091026: Baseline, A4091040: Week 24]
SF-36v2 is a self-administered questionnaire evaluating 8 aspects/domains of functional health and wellbeing: physical function, role physical, bodily pain, vitality, general health, social function, role emotional and mental health. The total score for each domain is scaled 0-100 (100 = highest level of functioning). Change from baseline >0 indicates an improvement.
- Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24 [A4091026: Baseline, A4091040: Week 24]
SF-36v2 is a self-administered questionnaire evaluating 8 aspects/domains of functional health and wellbeing: physical function, role physical, bodily pain, vitality, general health, social function, role emotional and mental health. Total score for each aspect were scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score -mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients must consent in writing to participate in the study.
-
Patients must be willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
-
Patients must have participated in the A4091026 study.
Exclusion Criteria:
-
Withdrawn from the A4091026 study for an adverse event or serious adverse event.
-
Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.
-
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jem Research, LLC | Atlantis | Florida | United States | 33462 |
| 2 | Medical Specialists of the Palm Beaches | Atlantis | Florida | United States | 33462 |
| 3 | Clinical Physiology Associates, Clinical Study Center | Fort Myers | Florida | United States | 33916 |
| 4 | Harris Bonnette, MD | Fort Myers | Florida | United States | 33919 |
| 5 | Arthritis & Rheumatic Care Center | South Miami | Florida | United States | 33143 |
| 6 | Miami Research Associates | South Miami | Florida | United States | 33143 |
| 7 | Neuroscience Consultants, LLC | South Miami | Florida | United States | 33143 |
| 8 | Asheville Imaging | Asheville | North Carolina | United States | 28801 |
| 9 | Biltmore Medical Associates | Asheville | North Carolina | United States | 28801 |
| 10 | Clinical Study Center of Asheville, LLC | Asheville | North Carolina | United States | 28803 |
| 11 | Asheville Neurology | Asheville | North Carolina | United States | 28806-2287 |
| 12 | Ohio Research Center | Toledo | Ohio | United States | 43623 |
| 13 | Blair Neurologic Associates | Altoona | Pennsylvania | United States | 16601 |
| 14 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 15 | Coastal Carolina Research Center in Goose Creek | Goose Creek | South Carolina | United States | 29445 |
| 16 | Tidewater Neurology | Goose Creek | South Carolina | United States | 29445 |
| 17 | Neurodiagnostic Laboratories of San Antonio, Inc | San Antonio | Texas | United States | 78229 |
| 18 | Radiant Research, Inc. | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00960804
Other Study ID Numbers:
- A4091040
- NERVE FUNCTION EXTENSION STUDY
First Posted:
Aug 18, 2009
Last Update Posted:
Feb 8, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants who received study drug and had end of study nerve function assessment data in previous study A4091026 (NCT00863772) were eligible to be enrolled in this study. Dosing interval between last dose in A4091026 (NCT00863772) and first dose in this study was not less than 8 weeks or more than 12 weeks. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Period Title: Overall Study | |||
| STARTED | 7 | 4 | 10 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 7 | 4 | 10 |
Baseline Characteristics
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Total of all reporting groups |
| Overall Participants | 7 | 4 | 10 | 21 |
| Age, Customized (Count of Participants) | ||||
| 45 to 64 years |
7
100%
|
2
50%
|
6
60%
|
15
71.4%
|
| Greater than or equal to (>=) 65 years |
0
0%
|
2
50%
|
4
40%
|
6
28.6%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
3
42.9%
|
3
75%
|
4
40%
|
10
47.6%
|
| Male |
4
57.1%
|
1
25%
|
6
60%
|
11
52.4%
|
Outcome Measures
| Title | Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate and Heart Rate-Deep Breathing, Normal Deviate (5NC [nd] + HRdb-[nd]) Composite Score at Week 24 |
|---|---|
| Description | 5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency [MNDL],peroneal nerve compound muscle action potential[CMAP],peroneal motor nerve conduction velocity[MNCV],tibial MNDL,sural sensory nerve action potential amplitude [SNAP])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score >0=worse response,less than(<)0=better response compared to normal matched population.Score change>0=worsening,<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values. |
| Time Frame | A4091026: Baseline, A4091040: Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using last observation carried forward (LOCF) method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline |
1.37
(3.19)
|
2.96
(1.02)
|
0.31
(2.76)
|
| Change at Week 24 |
0.28
(2.57)
|
1.79
(2.70)
|
-1.40
(2.83)
|
| Title | Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) at Week 24 |
|---|---|
| Description | NIS-LL:assess muscle weakness, reflexes, sensation;scored separately for left, right limbs. 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);sensation (touch pressure,pin-prick,vibration,joint position) scored 0=normal,1=decreased, or 2=absent. NIS-LL score: sum of scores of NIS items 17-24, 28-29 and 34-37. Total possible NIS-LL score range 0-88,high score=more impairment. |
| Time Frame | A4091026: Baseline, A4091040: Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline |
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
| Change at Week 24 |
1.14
(3.02)
|
0.00
(0.00)
|
0.00
(0.00)
|
| Title | Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score (NIS) at Week 24 |
|---|---|
| Description | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Time Frame | A4091026: Baseline, A4091040: Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline |
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
| Change at Week 24 |
2.00
(5.29)
|
0.00
(0.00)
|
0.00
(0.00)
|
| Title | Change From A4091026 (NCT00863772) Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24 |
|---|---|
| Description | NSC score is the number of the 38 symptom questions where the participants indicated experiencing the symptom to any severity. Total score range: 0 to 38 where higher score indicated more symptoms. |
| Time Frame | A4091026: Baseline, A4091040: Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline |
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
| Change at Week 24 |
0.00
(0.00)
|
0.25
(0.50)
|
0.10
(0.32)
|
| Title | Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24 |
|---|---|
| Description | 5NC (nd) score included five NCS attributes: peroneal MNDL, CMAP, MNCV; tibial MNDL; sural SNAP. Values of attributes scored as percentiles (calculated from distribution of normal values corresponding to participant's baseline demographic characteristics), then expressed as nd score based on standard normal distribution. For CMAP, MNCV, SNAP: score <0 indicated worse and >0 indicated better response; for peroneal,tibial MNDL: score >0 indicated worse and <0 indicated better response, as compared to normal matched population. For CMAP, MNCV, SNAP: score change <0 indicated worsening and >0 indicated improvement; for peroneal,tibial MNDL: score change >0 indicated worsening and <0 indicated improvement, as compared to baseline. Total score calculated as sum of each NCS attribute. Total score >0 indicated worse and <0 indicated better response as compared to normal matched population. Total score change >0 indicated worsening and <0 indicated improvement as compared to baseline. |
| Time Frame | A4091026: Baseline, A4091040: Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline: Peroneal CMAP |
-0.20
(1.16)
|
-0.85
(0.45)
|
0.13
(1.27)
|
| Baseline: Peroneal MNCV |
0.61
(1.55)
|
1.03
(1.02)
|
0.77
(1.78)
|
| Baseline: Peroneal MNDL |
-0.14
(0.70)
|
0.33
(0.51)
|
-0.09
(0.93)
|
| Baseline: Tibial MNDL |
0.82
(1.24)
|
1.41
(1.12)
|
0.97
(0.61)
|
| Baseline: Sural SNAP |
-0.95
(0.95)
|
-0.80
(1.04)
|
-0.72
(1.14)
|
| Baseline: 5NC (nd) composite score |
1.21
(2.90)
|
2.37
(1.38)
|
0.69
(2.71)
|
| Change at Week 24: Peroneal CMAP |
-1.03
(1.33)
|
-0.32
(0.45)
|
-0.02
(0.75)
|
| Change at Week 24: Peroneal MNCV |
-0.16
(0.81)
|
-0.50
(0.40)
|
0.16
(1.19)
|
| Change at Week 24: Peroneal MNDL |
-0.06
(1.34)
|
-0.82
(0.40)
|
-0.08
(0.71)
|
| Change at Week 24: Tibial MNDL |
-0.89
(1.42)
|
-0.38
(0.39)
|
-0.59
(1.15)
|
| Change at Week 24: Sural SNAP |
-0.29
(0.78)
|
-0.49
(0.57)
|
0.14
(1.01)
|
| Change at Week 24:5NC(nd) composite score |
0.53
(2.21)
|
1.33
(2.96)
|
-0.96
(2.40)
|
| Title | Change From A4091026 (NCT00863772) Baseline in Heart Rate-Deep Breathing, Normal Deviate (HRdb, [nd]) Score at Week 24 |
|---|---|
| Description | HRdb test was used to evaluate the effect of treatment on autonomic function. Participant took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as normal deviates. Score <0 indicated worse response and >0 indicated better response as compared to normal matched population. Score change <0 indicated worsening and >0 indicated improvement as compared to baseline. 2 neurological visits (NVs) were conducted both at baseline and Week 24. Measurements were collected twice and highest nd score was selected at each NV. Mean of the selected measurements was calculated to obtain Baseline and Week 24 values. |
| Time Frame | A4091026: Baseline, A4091040: Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline |
-0.16
(0.59)
|
-0.59
(0.36)
|
0.38
(1.15)
|
| Change at Week 24 |
0.25
(0.53)
|
-0.17
(0.35)
|
-0.21
(0.54)
|
| Title | Change From A4091026 (NCT00863772) Baseline in Intraepidermal Nerve Fiber Density (IENF) at Week 24 |
|---|---|
| Description | IENF density was quantified in 3 millimeter (mm) immunostained (PGP 9.5 immunohistochemical staining) skin punch biopsies taken from the distal end of the leg, 10 centimeter (cm) above the lateral malleolus, within the territory of the sural nerve, containing epidermis and superficial dermis to evaluate amount of small diameter nerve fibers. Skin biopsies were taken from normal appearing skin and skin having local scar, signs of trauma, ulceration, or active dermatologic process were avoided. |
| Time Frame | A4091026: Baseline, A4091040: Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline |
13.01
(6.54)
|
8.99
(5.79)
|
9.75
(4.46)
|
| Change at Week 24 |
-0.90
(3.02)
|
0.07
(1.47)
|
0.67
(4.26)
|
| Title | Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32 |
|---|---|
| Description | WOMAC Index: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items), and physical function (17 items) in participants with osteoarthritis of the index hip or index knee. Each question was assessed on Numeric Rating Scale (NRS) as 0(none) to 10(extreme).Total possible domain score was calculated as the mean of the score for each domain questions. Score range:0-10,high scores=high pain/stiffness/difficulty in physical activity. |
| Time Frame | A4091026: Baseline, A4091040: Week 8, 16, 24, 32 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. Results were not reported at Week 32 as none of the participants were evaluable for this measure at Week 32. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline: Pain |
5.66
(2.03)
|
6.75
(1.04)
|
6.70
(1.85)
|
| Baseline: Physical Function |
6.01
(1.50)
|
6.88
(0.92)
|
6.73
(1.94)
|
| Baseline: Stiffness |
6.64
(1.97)
|
6.88
(0.25)
|
6.65
(2.00)
|
| Change at Week 8: Pain |
-3.20
(2.61)
|
-4.45
(3.23)
|
-2.76
(2.03)
|
| Change at Week 8: Physical Function |
-3.38
(2.50)
|
-4.60
(2.88)
|
-2.24
(1.78)
|
| Change at Week 8: Stiffness |
-3.86
(3.01)
|
-4.75
(2.96)
|
-2.25
(2.84)
|
| Change at Week 16: Pain |
-2.91
(2.66)
|
-5.05
(2.04)
|
-2.84
(2.00)
|
| Change at Week 16: Physical Function |
-3.26
(2.46)
|
-5.22
(1.66)
|
-2.42
(2.04)
|
| Change at Week 16: Stiffness |
-3.79
(2.91)
|
-5.25
(2.02)
|
-2.50
(2.89)
|
| Change at Week 24: Pain |
-2.91
(2.66)
|
-5.05
(2.04)
|
-2.82
(2.00)
|
| Change at Week 24: Physical Function |
-3.26
(2.46)
|
-5.22
(1.66)
|
-2.42
(2.03)
|
| Change at Week 24: Stiffness |
-3.79
(2.91)
|
-5.25
(2.02)
|
-2.50
(2.89)
|
| Title | Change From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 8, 16, 24 and 32 |
|---|---|
| Description | PGA: Participants answered the following question: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants rated their condition using a 5-point Likert scale. Score range: 1 to 5. 1: Very Good (asymptomatic and no limitation of normal activities); 2: Good (mild symptoms and no limitation of normal activities); 3: Fair (moderate symptoms and limitation of some normal activites); 4: Poor (severe symptoms and inability to carry out most normal activities); 5: Very Poor (very severe symptoms which are intolerable and inability to carry out all normal activities). |
| Time Frame | A4091026: Baseline, A4091040: Week 8, 16, 24, 32 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. Results were not reported at Week 32 as none of the participants were evaluable for this measure at Week 32. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline |
3.00
(0.00)
|
3.50
(0.58)
|
3.70
(0.82)
|
| Change at Week 8 |
-0.86
(1.07)
|
-2.00
(0.00)
|
-1.10
(1.10)
|
| Change at Week 16 |
-1.00
(1.00)
|
-2.00
(0.00)
|
-1.20
(0.92)
|
| Change at Week 24 |
-1.00
(1.00)
|
-2.00
(0.00)
|
-1.30
(0.82)
|
| Title | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response |
|---|---|
| Description | OMERACT-OARSI response: >=50 percent (%) improvement from A4091026 (NCT00863772) baseline and absolute change from A4091026 (NCT00863772) baseline of >=2 units at week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: >=20% improvement from A4091026 (NCT00863772) baseline and absolute change from A4091026 (NCT00863772) baseline of >=1 unit at week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty). |
| Time Frame | Week 8, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Week 8 |
85.7
1224.3%
|
75.0
1875%
|
70.0
700%
|
| Week 16 |
85.7
1224.3%
|
100.0
2500%
|
70.0
700%
|
| Week 24 |
85.7
1224.3%
|
100.0
2500%
|
70.0
700%
|
| Title | Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 8, 16 and 24 |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response. Change from baseline <0 indicates an improvement. |
| Time Frame | A4091026: Baseline, A4091040: Week 8, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline |
6.10
(1.71)
|
6.83
(0.67)
|
6.69
(1.88)
|
| Change at Week 8 |
-3.48
(2.58)
|
-4.60
(2.99)
|
-2.42
(2.15)
|
| Change at Week 16 |
-3.32
(2.56)
|
-5.17
(1.85)
|
-2.59
(2.23)
|
| Change at Week 24 |
-3.32
(2.56)
|
-5.17
(1.85)
|
-2.58
(2.23)
|
| Title | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score |
|---|---|
| Description | The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. |
| Time Frame | Week 8, 16, 24, 32 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Week 8: >=30% Reduction |
85.7
1224.3%
|
75.0
1875%
|
60.0
600%
|
| Week 8: >=50% Reduction |
42.9
612.9%
|
75.0
1875%
|
60.0
600%
|
| Week 8: >=70% Reduction |
42.9
612.9%
|
75.0
1875%
|
10.0
100%
|
| Week 8: >=90% Reduction |
14.3
204.3%
|
50.0
1250%
|
10.0
100%
|
| Week 16: >=30% Reduction |
71.4
1020%
|
75.0
1875%
|
60.0
600%
|
| Week 16: >=50% Reduction |
42.9
612.9%
|
75.0
1875%
|
60.0
600%
|
| Week 16: >=70% Reduction |
42.9
612.9%
|
75.0
1875%
|
20.0
200%
|
| Week 16: >=90% Reduction |
14.3
204.3%
|
50.0
1250%
|
10.0
100%
|
| Week 24: >=30% Reduction |
71.4
1020%
|
75.0
1875%
|
60.0
600%
|
| Week 24: >=50% Reduction |
42.9
612.9%
|
75.0
1875%
|
60.0
600%
|
| Week 24: >=70% Reduction |
42.9
612.9%
|
75.0
1875%
|
20.0
200%
|
| Week 24: >=90% Reduction |
14.3
204.3%
|
50.0
1250%
|
10.0
100%
|
| Week 32: >=30% Reduction |
71.4
1020%
|
75.0
1875%
|
60.0
600%
|
| Week 32: >=50% Reduction |
42.9
612.9%
|
75.0
1875%
|
60.0
600%
|
| Week 32: >=70% Reduction |
42.9
612.9%
|
75.0
1875%
|
20.0
200%
|
| Week 32: >=90% Reduction |
14.3
204.3%
|
50.0
1250%
|
10.0
100%
|
| Title | Percentage of Participants With Improvement of At Least 2 Points From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis |
|---|---|
| Description | PGA: Participants answered the following question: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants rated their condition using a 5-point Likert scale. Score range: 1 to 5. 1: Very Good (asymptomatic and no limitation of normal activities); 2: Good (mild symptoms and no limitation of normal activities); 3: Fair (moderate symptoms and limitation of some normal activites); 4: Poor (severe symptoms and inability to carry out most normal activities); 5: Very Poor (very severe symptoms which are intolerable and inability to carry out all normal activities). |
| Time Frame | Week 8, 16, 24, 32 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Week 8 |
0
0%
|
0
0%
|
10.0
100%
|
| Week 16 |
0
0%
|
0
0%
|
10.0
100%
|
| Week 24 |
0
0%
|
0
0%
|
20.0
200%
|
| Week 32 |
0
0%
|
0
0%
|
20.0
200%
|
| Title | Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24 |
|---|---|
| Description | SF-36v2 is a self-administered questionnaire evaluating 8 aspects/domains of functional health and wellbeing: physical function, role physical, bodily pain, vitality, general health, social function, role emotional and mental health. The total score for each domain is scaled 0-100 (100 = highest level of functioning). Change from baseline >0 indicates an improvement. |
| Time Frame | A4091026: Baseline, A4091040: Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline: General Health |
67.71
(16.18)
|
79.50
(9.57)
|
77.40
(9.61)
|
| Baseline: Physical Function |
55.00
(24.15)
|
47.50
(35.24)
|
39.00
(23.43)
|
| Baseline: Role Physical |
66.96
(23.31)
|
53.13
(36.98)
|
34.38
(26.88)
|
| Baseline: Bodily Pain |
51.14
(25.20)
|
42.25
(22.54)
|
33.50
(19.05)
|
| Baseline: Vitality |
54.46
(21.56)
|
59.38
(15.73)
|
61.88
(24.02)
|
| Baseline: Social Function |
82.14
(20.23)
|
78.13
(25.77)
|
82.50
(17.87)
|
| Baseline: Role Emotional |
79.76
(20.33)
|
79.17
(25.00)
|
70.83
(21.61)
|
| Baseline: Mental Health |
73.57
(16.26)
|
81.25
(8.54)
|
87.00
(14.38)
|
| Change at Week 24: General Health |
1.57
(12.22)
|
6.25
(4.79)
|
-3.90
(13.10)
|
| Change at Week 24: Physical Function |
14.29
(27.60)
|
25.00
(10.80)
|
5.00
(32.32)
|
| Change at Week 24: Role Physical |
8.04
(25.95)
|
31.25
(24.47)
|
17.50
(14.37)
|
| Change at Week 24: Bodily Pain |
8.00
(35.23)
|
34.75
(14.03)
|
13.60
(19.39)
|
| Change at Week 24: Vitality |
7.14
(14.17)
|
17.19
(11.83)
|
3.75
(5.27)
|
| Change at Week 24: Social Function |
3.57
(11.89)
|
21.88
(25.77)
|
0.00
(15.59)
|
| Change at Week 24: Role Emotional |
-2.38
(30.32)
|
6.25
(29.95)
|
5.00
(23.31)
|
| Change at Week 24: Mental Health |
1.43
(14.06)
|
8.75
(8.54)
|
-5.50
(8.32)
|
| Title | Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24 |
|---|---|
| Description | SF-36v2 is a self-administered questionnaire evaluating 8 aspects/domains of functional health and wellbeing: physical function, role physical, bodily pain, vitality, general health, social function, role emotional and mental health. Total score for each aspect were scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score -mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement. |
| Time Frame | A4091026: Baseline, A4091040: Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using LOCF method. |
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care |
|---|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. |
| Measure Participants | 7 | 4 | 10 |
| Baseline: Mental Component Score |
0.17
(0.92)
|
0.55
(0.61)
|
0.83
(1.17)
|
| Baseline: Physical Component Score |
-0.95
(1.08)
|
-1.33
(1.04)
|
-1.88
(0.63)
|
| Change at Week 24: Mental Component Score |
-0.09
(0.90)
|
0.28
(0.93)
|
-0.19
(0.50)
|
| Change at Week 24: Physical Component Score |
0.50
(1.03)
|
1.27
(0.39)
|
0.50
(0.95)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care | |||
| Arm/Group Description | Participants who had previously received tanezumab (RN624 or PF-04383119) 5 milligram (mg) intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 5 mg intravenous infusion over 5 minutes every 8 weeks along with standard of care (SOC) as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, non-steroidal anti-inflammatory drugs [NSAIDs], capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States Food and Drug Administration (FDA) or other applicable Health Authorities. | Participants who had previously received tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion in parent study A4091026 (NCT00863772), received tanezumab 10 mg intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | Participants who had previously received placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion in parent study A4091026 (NCT00863772), received placebo matched to tanezumab intravenous infusion over 5 minutes every 8 weeks along with SOC as per investigator's discretion up to 32 weeks. SOC included analgesic medications (opioids, topical analgesics, NSAIDs, capsaicin products, injectable corticosteroids, and viscosupplementation) approved by United States FDA or other applicable Health Authorities. | |||
All Cause Mortality |
||||||
| Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/7 (14.3%) | 1/4 (25%) | 0/10 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Osteoarthritis | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Osteonecrosis | 0/7 (0%) | 1/4 (25%) | 0/10 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Tanezumab 5 mg + Standard of Care | Tanezumab 10 mg + Standard of Care | Placebo + Standard of Care | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/7 (85.7%) | 3/4 (75%) | 4/10 (40%) | |||
| Eye disorders | ||||||
| Vitreous floaters | 0/7 (0%) | 0/4 (0%) | 1/10 (10%) | |||
| General disorders | ||||||
| Oedema peripheral | 0/7 (0%) | 0/4 (0%) | 1/10 (10%) | |||
| Immune system disorders | ||||||
| Seasonal allergy | 0/7 (0%) | 0/4 (0%) | 1/10 (10%) | |||
| Infections and infestations | ||||||
| Bronchitis | 0/7 (0%) | 1/4 (25%) | 0/10 (0%) | |||
| Diverticulitis | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Contusion | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Fall | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Investigations | ||||||
| Nerve conduction studies abnormal | 0/7 (0%) | 0/4 (0%) | 1/10 (10%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 3/7 (42.9%) | 2/4 (50%) | 0/10 (0%) | |||
| Bursitis | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Lumbar spinal stenosis | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Musculoskeletal pain | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Myositis | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Neck pain | 0/7 (0%) | 0/4 (0%) | 1/10 (10%) | |||
| Osteoarthritis | 2/7 (28.6%) | 1/4 (25%) | 0/10 (0%) | |||
| Pain in extremity | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Spinal column stenosis | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Joint swelling | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Basal cell carcinoma | 0/7 (0%) | 1/4 (25%) | 0/10 (0%) | |||
| Nervous system disorders | ||||||
| Hypoaesthesia | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Muscle contractions involuntary | 0/7 (0%) | 0/4 (0%) | 1/10 (10%) | |||
| Sciatica | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Ecchymosis | 1/7 (14.3%) | 0/4 (0%) | 0/10 (0%) | |||
Limitations/Caveats
Due to FDA-imposed clinical hold, enrollment stopped prematurely, thus inadequate power to fulfill primary objectives.Efficacy data beyond Week 32 not collected.Change in planned analysis added results of >=70%, 90% reduction in WOMAC pain subscale.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00960804
Other Study ID Numbers:
- A4091040
- NERVE FUNCTION EXTENSION STUDY
First Posted:
Aug 18, 2009
Last Update Posted:
Feb 8, 2021
Last Verified:
Nov 1, 2020