Open-label Extension Study Of RN624
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00399490
Collaborator
(none)
287
36
1
16.9
8
0.5
Study Details
Study Description
Brief Summary
Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
287 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
OPEN-LABEL, MULTIPLE-DOSE STUDY OF THE SAFETY AND EFFICACY OF RN624 IN ADULTS WITH PAIN DUE TO OSTEOARTHRITIS OF THE KNEE.
Actual Study Start Date
:
Sep 15, 2006
Actual Primary Completion Date
:
Feb 11, 2008
Actual Study Completion Date
:
Feb 11, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: RN624 (PF-04383119)
50 mcg/kg
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 12 weeks after last dose of study drug]
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events.
Secondary Outcome Measures
- Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 [A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72]
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from the five individual questions scored on a visual analog scale (VAS) of 0 to 100, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 100, where higher scores indicate higher pain.
- Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 [A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72]
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from the 2 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC stiffness subscale score is 0 to 100, where higher scores indicate worse function. Stiffness is defined as a sensation of decreased ease in movement of knee.
- Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 [A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72]
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 100, where higher scores indicate worse function.
- Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 [A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72]
Participants answered: "In the past 24 hours, how much pain have you had in your index knee caused by your osteoarthritis?" Participants responded by using a VAS of 0 to 100, where 0 = no pain and 100 = extreme pain, higher scores indicated more pain.
- Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 [A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72]
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a VAS of 0 to 100, where 0 = very poor and 100 = very good, where higher scores indicated better health condition.
- Number of Participants With Response to Participant Satisfaction Questionnaire [A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72]
Participants answered: "Overall, how satisfied are you with the study drug treatment you received as part of this study?" Participants responded by selecting the most appropriate among the following responses: not at all satisfied, a little satisfied, somewhat satisfied, and very satisfied.
- Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 [A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72]
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). The total score for each section and 2 component scores are an average of the individual question scores, which are scaled from 0 to 100, where 0=lowest level of functioning and 100=highest level of functioning, higher scores indicated better functioning .
- Percentage of Participants Who Discontinued the Study [A4091009: Baseline up to 12 weeks after last dose of study drug]
- Median Time in Study A4091009 [A4091009: Baseline up to 12 weeks after last dose of study drug]
Median time of participation in the study for all the participants was evaluated.
Other Outcome Measures
- Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study [A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of Study (12 weeks after the last dose of study drug)]
HVLT-R: instrument consisting of 12 noun list, used to measure verbal learning and memory (recognition and recall). List was read to participant, who then attempted to recall as many words as possible. The examiner recorded each response. Task was repeated 2 more times, for total of 3 learning trials. After delay interval of 20-25 minutes, delayed recall trial was administered. Total score (TS) = sum of 3 learning trial scores of 12 word each, ranged: 0 (no memory) to 36 (best memory), where higher scores indicated better memory. Delayed recall (DR) = number of words recalled in delayed recall test, ranged: 0 (no memory) to 12 (best memory), where higher scores indicated better memory.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Enrolled in Study RN624-CL006
Exclusion Criteria:
-
The occurrence of any adverse event or condition during the controlled studies that, in the opinion of the Investigator, should exclude the subject from participating in the open-label extension
-
Pregnant or lactating female subjects or subjects who do not agree to use an appropriate form of birth control throughout the study and for 3 months after completing the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BrookWood Internal Medicine | Birmingham | Alabama | United States | 35209 |
| 2 | Radiant Research | Birmingham | Alabama | United States | 35209 |
| 3 | Arizona Research Center, LLC | Phoenix | Arizona | United States | 85023 |
| 4 | Imaging Centers of Anaheim | Anaheim | California | United States | 92801 |
| 5 | Orange County Clinical Research | Anaheim | California | United States | 92801 |
| 6 | Synergy Clinical Research Center | National City | California | United States | 91950 |
| 7 | David M. Radin, MD | Stamford | Connecticut | United States | 06905 |
| 8 | Stamford Therapeutics Consortium | Stamford | Connecticut | United States | 06905 |
| 9 | Covance Clinical Research Unit, Inc | Daytona Beach | Florida | United States | 32117 |
| 10 | Ocala Rheumatology Research Center | Ocala | Florida | United States | 34474-7455 |
| 11 | Tampa Medical Group, PA | Tampa | Florida | United States | 33614-7118 |
| 12 | Habana Hospital Pharmacy | Tampa | Florida | United States | 33614 |
| 13 | Covance Clinical Research Unit, Inc. Honolulu | Honolulu | Hawaii | United States | 96813 |
| 14 | Covance Boise | Boise | Idaho | United States | 83704 |
| 15 | Northwest Indiana Center for Clinical Research | Merrillville | Indiana | United States | 46410 |
| 16 | Office of David Neustadt, PSL | Louisville | Kentucky | United States | 40202 |
| 17 | The Center for Rheumatology and Bone Research | Wheaton | Maryland | United States | 20902 |
| 18 | Clinical Pharmacology Study Group | Worcester | Massachusetts | United States | 01610 |
| 19 | Center for Pharmaceutical Research, P.C. | Kansas City | Missouri | United States | 64114 |
| 20 | Quality Clincal Research | Omaha | Nebraska | United States | 68114 |
| 21 | Albuquerque Clinical Trials | Albuquerque | New Mexico | United States | 87102 |
| 22 | AAIR Research Center | Rochester | New York | United States | 14618 |
| 23 | Sports Medicine and Orthopaedics Center | Greensboro | North Carolina | United States | 27401 |
| 24 | Pharmquest | Greensboro | North Carolina | United States | 27408 |
| 25 | Pharmacotherapy Research Associates Incorporated | Zanesville | Ohio | United States | 43701 |
| 26 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 27 | New Orleans Center for Clinical Research | Knoxville | Tennessee | United States | 37920 |
| 28 | Volunteer Research Group | Knoxville | Tennessee | United States | 37920 |
| 29 | Office of Walter F. Chase, MD, PA | Austin | Texas | United States | 78705 |
| 30 | Radiant Research - San Antonio | San Antonio | Texas | United States | 78217 |
| 31 | Radiant Research San Antonio Northeast | San Antonio | Texas | United States | 78217 |
| 32 | Rheumatology Associates of South Texas | San Antonio | Texas | United States | 78217 |
| 33 | South Texas Radiology Imaging Center | San Antonio | Texas | United States | 78217 |
| 34 | Pivotal Research | Midvale | Utah | United States | 84047 |
| 35 | Charlottesville Medical Research | Charlottesville | Virginia | United States | 22911 |
| 36 | Clinical Trials Northwest | Yakima | Washington | United States | 98902 |
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:
NCT00399490
Other Study ID Numbers:
- A4091009
- RN624-CL007
First Posted:
Nov 15, 2006
Last Update Posted:
Feb 2, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants who had received at least 2 infusions of study drug and had been followed for 56 days after the last infusion in previous study A4091008 (NCT00394563) were eligible to be enrolled in this study. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Tanezumab 50 mcg/kg |
|---|---|
| Arm/Group Description | Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Period Title: Overall Study | |
| STARTED | 281 |
| COMPLETED | 183 |
| NOT COMPLETED | 98 |
Baseline Characteristics
| Arm/Group Title | Tanezumab 50 mcg/kg |
|---|---|
| Arm/Group Description | Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Overall Participants | 281 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
59.3
(8.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
171
60.9%
|
| Male |
110
39.1%
|
Outcome Measures
| Title | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
|---|---|
| Description | AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events. |
| Time Frame | Baseline up to 12 weeks after last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who had received at least 1 study drug infusion in this study, A4091009 (NCT00399490). |
| Arm/Group Title | Tanezumab 50 mcg/kg |
|---|---|
| Arm/Group Description | Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 281 |
| AEs |
168
59.8%
|
| SAEs |
8
2.8%
|
| Title | Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
|---|---|
| Description | The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from the five individual questions scored on a visual analog scale (VAS) of 0 to 100, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 100, where higher scores indicate higher pain. |
| Time Frame | A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population included all participants who received at least 1 study drug infusion (in this study,A4091009[NCT00399490]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row. |
| Arm/Group Title | Tanezumab 50 mcg/kg (Previous Tanezumab Treatment) | Tanezumab 50 mcg/kg (Previous Placebo Treatment) |
|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. | Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 236 | 40 |
| Baseline |
67.4
(12.44)
|
67.4
(11.04)
|
| Change at Week 0 |
-25.3
(25.68)
|
-16.6
(24.21)
|
| Change at Week 4 |
-38.0
(24.54)
|
-39.1
(21.93)
|
| Change at Week 8 |
-35.9
(24.68)
|
-34.1
(24.04)
|
| Change at Week 16 |
-33.5
(25.47)
|
-37.3
(21.42)
|
| Change at Week 24 |
-30.6
(26.31)
|
-34.0
(22.36)
|
| Change at Week 32 |
-35.4
(24.25)
|
-27.8
(23.12)
|
| Change at Week 40 |
-27.9
(25.10)
|
-28.5
(24.91)
|
| Change at Week 48 |
-25.0
(22.86)
|
-26.3
(23.91)
|
| Change at Week 56 |
-17.2
(23.82)
|
-22.4
(22.32)
|
| Change at Week 64 |
-18.6
(24.92)
|
-9.7
(28.70)
|
| Change at Week 72 |
-15.6
(31.40)
|
-28.3
(5.23)
|
| Title | Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
|---|---|
| Description | The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from the 2 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC stiffness subscale score is 0 to 100, where higher scores indicate worse function. Stiffness is defined as a sensation of decreased ease in movement of knee. |
| Time Frame | A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 [NCT00399490]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row. |
| Arm/Group Title | Tanezumab 50 mcg/kg (Previous Tanezumab Treatment) | Tanezumab 50 mcg/kg (Previous Placebo Treatment) |
|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. | Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 236 | 40 |
| Baseline |
71.9
(15.21)
|
71.6
(13.65)
|
| Change at Week 0 |
-25.0
(27.92)
|
-17.4
(24.27)
|
| Change at Week 4 |
-40.8
(26.19)
|
-42.2
(21.35)
|
| Change at Week 8 |
-38.9
(27.50)
|
-36.6
(25.45)
|
| Change at Week 16 |
-34.0
(27.61)
|
-39.7
(23.93)
|
| Change at Week 24 |
-33.2
(28.97)
|
-34.7
(24.47)
|
| Change at Week 32 |
-38.1
(26.20)
|
-26.6
(24.27)
|
| Change at Week 40 |
-27.7
(30.94)
|
-33.0
(26.57)
|
| Change at Week 48 |
-28.6
(27.59)
|
-26.6
(24.58)
|
| Change at Week 56 |
-18.7
(25.96)
|
-22.6
(20.67)
|
| Change at Week 64 |
-22.0
(29.82)
|
-8.1
(33.04)
|
| Change at Week 72 |
-12.8
(26.52)
|
-19.0
(14.14)
|
| Title | Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
|---|---|
| Description | The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 100, where higher scores indicate worse function. |
| Time Frame | A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 [NCT00399490]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row. |
| Arm/Group Title | Tanezumab 50 mcg/kg (Previous Tanezumab Treatment) | Tanezumab 50 mcg/kg (Previous Placebo Treatment) |
|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. | Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 236 | 40 |
| Baseline |
66.7
(13.79)
|
67.6
(13.30)
|
| Change at Week 0 |
-24.3
(25.04)
|
-15.9
(22.04)
|
| Change at Week 4 |
-37.9
(23.94)
|
-40.2
(20.28)
|
| Change at Week 8 |
-35.4
(24.18)
|
-34.9
(23.10)
|
| Change at Week 16 |
-32.5
(24.57)
|
-38.1
(23.72)
|
| Change at Week 24 |
-29.1
(24.62)
|
-33.0
(23.45)
|
| Change at Week 32 |
-33.3
(24.29)
|
-27.1
(23.95)
|
| Change at Week 40 |
-26.8
(26.05)
|
-30.3
(22.71)
|
| Change at Week 48 |
-24.1
(24.55)
|
-23.6
(23.16)
|
| Change at Week 56 |
-14.1
(24.62)
|
-22.7
(20.35)
|
| Change at Week 64 |
-20.7
(23.80)
|
-7.8
(28.39)
|
| Change at Week 72 |
-8.6
(19.42)
|
-21.4
(4.66)
|
| Title | Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
|---|---|
| Description | Participants answered: "In the past 24 hours, how much pain have you had in your index knee caused by your osteoarthritis?" Participants responded by using a VAS of 0 to 100, where 0 = no pain and 100 = extreme pain, higher scores indicated more pain. |
| Time Frame | A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 [NCT00399490]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row. |
| Arm/Group Title | Tanezumab 50 mcg/kg (Previous Tanezumab Treatment) | Tanezumab 50 mcg/kg (Previous Placebo Treatment) |
|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. | Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 237 | 40 |
| Baseline |
69.8
(10.13)
|
68.5
(9.65)
|
| Change at Week 0 |
-22.0
(27.46)
|
-13.0
(26.84)
|
| Change at Week 4 |
-36.5
(25.59)
|
-39.6
(22.31)
|
| Change at Week 8 |
-34.5
(27.93)
|
-31.8
(27.06)
|
| Change at Week 16 |
-30.2
(28.43)
|
-36.9
(24.88)
|
| Change at Week 24 |
-28.5
(29.77)
|
-29.6
(27.95)
|
| Change at Week 32 |
-32.2
(29.29)
|
-21.2
(28.05)
|
| Change at Week 40 |
-26.6
(30.78)
|
-27.1
(25.13)
|
| Change at Week 48 |
-22.5
(27.30)
|
-25.2
(29.83)
|
| Change at Week 56 |
-14.0
(30.20)
|
-8.7
(28.32)
|
| Change at Week 64 |
-16.4
(32.61)
|
-10.8
(36.99)
|
| Change at Week 72 |
-8.4
(17.15)
|
-29.0
(24.63)
|
| Title | Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
|---|---|
| Description | Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a VAS of 0 to 100, where 0 = very poor and 100 = very good, where higher scores indicated better health condition. |
| Time Frame | A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 [NCT00399490]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row. |
| Arm/Group Title | Tanezumab 50 mcg/kg (Previous Tanezumab Treatment) | Tanezumab 50 mcg/kg (Previous Placebo Treatment) |
|---|---|---|
| Arm/Group Description | Participants who had previously received tanezumab 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. | Participants who had previously received placebo matched to tanezumab intravenous infusion in parent study A4091008, received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 236 | 40 |
| Baseline |
53.3
(19.79)
|
50.5
(19.63)
|
| Change at Week 0 |
10.4
(26.33)
|
8.4
(20.32)
|
| Change at Week 4 |
20.3
(29.16)
|
25.9
(24.54)
|
| Change at Week 8 |
18.5
(28.28)
|
21.7
(26.28)
|
| Change at Week 16 |
15.7
(28.66)
|
18.2
(31.85)
|
| Change at Week 24 |
11.1
(30.83)
|
10.9
(33.93)
|
| Change at Week 32 |
15.9
(30.33)
|
6.5
(28.76)
|
| Change at Week 40 |
11.1
(31.18)
|
4.2
(29.16)
|
| Change at Week 48 |
6.7
(25.51)
|
7.5
(26.41)
|
| Change at Week 56 |
-8.0
(32.85)
|
6.6
(18.94)
|
| Change at Week 64 |
9.4
(22.87)
|
0.8
(30.05)
|
| Change at Week 72 |
5.0
(12.73)
|
25.5
(17.68)
|
| Title | Number of Participants With Response to Participant Satisfaction Questionnaire |
|---|---|
| Description | Participants answered: "Overall, how satisfied are you with the study drug treatment you received as part of this study?" Participants responded by selecting the most appropriate among the following responses: not at all satisfied, a little satisfied, somewhat satisfied, and very satisfied. |
| Time Frame | A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 [NCT00399490]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row. |
| Arm/Group Title | Tanezumab 50 mcg/kg |
|---|---|
| Arm/Group Description | Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 267 |
| Baseline: Very Satisfied |
191
68%
|
| Baseline: Somewhat Satisfied |
36
12.8%
|
| Baseline: A Little Satisfied |
14
5%
|
| Baseline: Not at all Satisfied |
26
9.3%
|
| Week 4: Very Satisfied |
189
67.3%
|
| Week 4: Somewhat Satisfied |
57
20.3%
|
| Week 4: A Little Satisfied |
11
3.9%
|
| Week 4: Not at all Satisfied |
2
0.7%
|
| Week 8: Very Satisfied |
204
72.6%
|
| Week 8: Somewhat Satisfied |
35
12.5%
|
| Week 8: A Little Satisfied |
9
3.2%
|
| Week 8: Not at all Satisfied |
3
1.1%
|
| Week 16: Very Satisfied |
162
57.7%
|
| Week 16: Somewhat Satisfied |
36
12.8%
|
| Week 16: A Little Satisfied |
12
4.3%
|
| Week 16: Not at all Satisfied |
1
0.4%
|
| Week 24: Very Satisfied |
139
49.5%
|
| Week 24: Somewhat Satisfied |
27
9.6%
|
| Week 24: A Little Satisfied |
8
2.8%
|
| Week 24: Not at all Satisfied |
1
0.4%
|
| Week 32: Very Satisfied |
105
37.4%
|
| Week 32: Somewhat Satisfied |
21
7.5%
|
| Week 32: A Little Satisfied |
5
1.8%
|
| Week 32: Not at all Satisfied |
1
0.4%
|
| Week 40: Very Satisfied |
72
25.6%
|
| Week 40: Somewhat Satisfied |
10
3.6%
|
| Week 40: A Little Satisfied |
3
1.1%
|
| Week 40: Not at all Satisfied |
1
0.4%
|
| Week 48: Very Satisfied |
46
16.4%
|
| Week 48: Somewhat Satisfied |
7
2.5%
|
| Week 48: A Little Satisfied |
3
1.1%
|
| Week 48: Not at all Satisfied |
0
0%
|
| Week 56: Very Satisfied |
27
9.6%
|
| Week 56: Somewhat Satisfied |
3
1.1%
|
| Week 56: A Little Satisfied |
2
0.7%
|
| Week 56: Not at all Satisfied |
0
0%
|
| Week 64: Very Satisfied |
16
5.7%
|
| Week 64: Somewhat Satisfied |
2
0.7%
|
| Week 64: A Little Satisfied |
0
0%
|
| Week 64: Not at all Satisfied |
0
0%
|
| Week 72: Very Satisfied |
4
1.4%
|
| Week 72: Somewhat Satisfied |
0
0%
|
| Week 72: A Little Satisfied |
0
0%
|
| Week 72: Not at all Satisfied |
0
0%
|
| Title | Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). The total score for each section and 2 component scores are an average of the individual question scores, which are scaled from 0 to 100, where 0=lowest level of functioning and 100=highest level of functioning, higher scores indicated better functioning . |
| Time Frame | A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants who received at least 1 study drug infusion (in this study, A4091009 [NCT00399490]) and had at least 1 evaluation post infusion. Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row. |
| Arm/Group Title | Tanezumab 50 mcg/kg |
|---|---|
| Arm/Group Description | Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 271 |
| Baseline: General Health |
75.9
(16.97)
|
| Baseline: Physical Function |
45.4
(21.40)
|
| Baseline: Role Physical |
63.3
(23.61)
|
| Baseline: Bodily Pain |
50.4
(19.86)
|
| Baseline: Vitality |
63.2
(18.24)
|
| Baseline: Social Functioning |
83.9
(19.88)
|
| Baseline: Role Emotional |
81.3
(22.54)
|
| Baseline: Mental Health |
82.8
(13.45)
|
| Change at Week 4: General Health |
3.5
(17.08)
|
| Change at Week 4: Physical Function |
10.4
(19.09)
|
| Change at Week 4: Role Physical |
9.8
(21.45)
|
| Change at Week 4: Bodily Pain |
11.3
(22.90)
|
| Change at Week 4: Vitality |
6.4
(18.47)
|
| Change at Week 4: Social Function |
6.6
(23.29)
|
| Change at Week 4: Role Emotional |
6.3
(23.09)
|
| Change at Week 4: Mental Health |
4.8
(20.39)
|
| Change at Week 8: General Health |
3.5
(18.02)
|
| Change at Week 8: Physical Function |
8.6
(19.39)
|
| Change at Week 8: Role Physical |
6.7
(20.15)
|
| Change at Week 8: Bodily Pain |
10.9
(22.11)
|
| Change at Week 8: Vitality |
4.4
(18.51)
|
| Change at Week 8: Social Function |
5.1
(22.41)
|
| Change at Week 8: Role Emotional |
5.0
(22.87)
|
| Change at Week 8: Mental Health |
4.3
(19.11)
|
| Change at Week 16: General Health |
2.4
(17.10)
|
| Change at Week 16: Physical Function |
7.8
(20.79)
|
| Change at Week 16: Role Physical |
5.0
(22.86)
|
| Change at Week 16: Bodily Pain |
8.5
(24.93)
|
| Change at Week 16: Vitality |
3.7
(19.59)
|
| Change at Week 16: Social Function |
4.4
(24.04)
|
| Change at Week 16: Role Emotional |
3.4
(23.24)
|
| Change at Week 16: Mental Health |
1.4
(19.21)
|
| Change at Week 24: General Health |
2.4
(20.82)
|
| Change at Week 24: Physical Function |
6.6
(21.49)
|
| Change at Week 24: Role Physical |
4.2
(24.74)
|
| Change at Week 24: Bodily Pain |
6.1
(26.06)
|
| Change at Week 24: Vitality |
4.3
(21.18)
|
| Change at Week 24: Social Function |
4.9
(28.94)
|
| Change at Week 24: Role Emotional |
4.2
(27.76)
|
| Change at Week 24: Mental Health |
3.4
(23.40)
|
| Change at Week 32: General Health |
1.8
(16.68)
|
| Change at Week 32: Physical Function |
4.3
(22.67)
|
| Change at Week 32: Role Physical |
0.6
(27.42)
|
| Change at Week 32: Bodily Pain |
5.9
(25.26)
|
| Change at Week 32: Vitality |
-0.7
(21.17)
|
| Change at Week 32: Social Function |
1.2
(26.23)
|
| Change at Week 32: Role Emotional |
1.3
(25.79)
|
| Change at Week 32: Mental Health |
0.9
(20.55)
|
| Change at Week 40: General Health |
1.2
(20.50)
|
| Change at Week 40: Physical Function |
4.4
(25.87)
|
| Change at Week 40: Role Physical |
3.7
(28.57)
|
| Change at Week 40: Bodily Pain |
4.1
(29.75)
|
| Change at Week 40: Vitality |
1.7
(25.69)
|
| Change at Week 40: Social Function |
3.9
(28.41)
|
| Change at Week 40: Role Emotional |
0.7
(31.17)
|
| Change at Week 40: Mental Health |
2.2
(24.06)
|
| Change at Week 48: General Health |
2.2
(22.13)
|
| Change at Week 48: Physical Function |
-0.9
(25.28)
|
| Change at Week 48: Role Physical |
-5.2
(31.66)
|
| Change at Week 48: Bodily Pain |
0.4
(27.77)
|
| Change at Week 48: Vitality |
-2.8
(24.14)
|
| Change at Week 48: Social Function |
-2.1
(30.99)
|
| Change at Week 48: Role Emotional |
-5.1
(32.43)
|
| Change at Week 48: Mental Health |
1.4
(24.70)
|
| Change at Week 56: General Health |
-0.5
(19.18)
|
| Change at Week 56: Physical Function |
-3.5
(24.90)
|
| Change at Week 56: Role Physical |
-6.2
(28.08)
|
| Change at Week 56: Bodily Pain |
-0.4
(22.64)
|
| Change at Week 56: Vitality |
-3.9
(21.99)
|
| Change at Week 56: Social Function |
-4.6
(26.65)
|
| Change at Week 56: Role Emotional |
-6.2
(29.92)
|
| Change at Week 56: Mental Health |
-6.2
(21.69)
|
| Change at Week 64: General Health |
0.5
(23.42)
|
| Change at Week 64: Physical Function |
-2.6
(14.27)
|
| Change at Week 64: Role Physical |
-1.6
(25.04)
|
| Change at Week 64: Bodily Pain |
-2.9
(22.13)
|
| Change at Week 64: Vitality |
-4.4
(24.09)
|
| Change at Week 64: Social Function |
-0.5
(32.43)
|
| Change at Week 64: Role Emotional |
-2.6
(30.12)
|
| Change at Week 64: Mental Health |
2.1
(26.50)
|
| Change at Week 72: General Health |
-5.0
(4.08)
|
| Change at Week 72: Physical Function |
5.0
(14.72)
|
| Change at Week 72: Role Physical |
0.0
(5.10)
|
| Change at Week 72: Bodily Pain |
-0.0
(14.63)
|
| Change at Week 72: Vitality |
-9.4
(10.83)
|
| Change at Week 72: Social Function |
6.3
(7.22)
|
| Change at Week 72: Role Emotional |
-10.4
(12.50)
|
| Change at Week 72: Mental Health |
-1.3
(9.46)
|
| Title | Percentage of Participants Who Discontinued the Study |
|---|---|
| Description | |
| Time Frame | A4091009: Baseline up to 12 weeks after last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who had received at least 1 study drug infusion in this study, A4091009 (NCT00399490). |
| Arm/Group Title | Tanezumab 50 mcg/kg |
|---|---|
| Arm/Group Description | Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 281 |
| Number [percentage of participants] |
34.9
12.4%
|
| Title | Median Time in Study A4091009 |
|---|---|
| Description | Median time of participation in the study for all the participants was evaluated. |
| Time Frame | A4091009: Baseline up to 12 weeks after last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who had received at least 1 study drug infusion in this study, A4091009 (NCT00399490). |
| Arm/Group Title | Tanezumab 50 mcg/kg |
|---|---|
| Arm/Group Description | Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 281 |
| Median (Full Range) [days] |
198
|
| Title | Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of Study |
|---|---|
| Description | HVLT-R: instrument consisting of 12 noun list, used to measure verbal learning and memory (recognition and recall). List was read to participant, who then attempted to recall as many words as possible. The examiner recorded each response. Task was repeated 2 more times, for total of 3 learning trials. After delay interval of 20-25 minutes, delayed recall trial was administered. Total score (TS) = sum of 3 learning trial scores of 12 word each, ranged: 0 (no memory) to 36 (best memory), where higher scores indicated better memory. Delayed recall (DR) = number of words recalled in delayed recall test, ranged: 0 (no memory) to 12 (best memory), where higher scores indicated better memory. |
| Time Frame | A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of Study (12 weeks after the last dose of study drug) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who had received at least 1 study drug infusion in this study, A4091009 (NCT00399490). Here, "overall number of participants analyzed" signifies participants evaluable for this OM and "number analyzed" signifies participants evaluable at each specified row. |
| Arm/Group Title | Tanezumab 50 mcg/kg |
|---|---|
| Arm/Group Description | Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. |
| Measure Participants | 277 |
| Baseline: TS |
31.5
(3.75)
|
| Baseline: DR |
11.2
(1.44)
|
| Change at Week 4: TS |
-0.0
(3.44)
|
| Change at Week 4: DR |
-0.0
(1.16)
|
| Change at Week 8: TS |
-0.2
(3.43)
|
| Change at Week 8: DR |
0.1
(1.45)
|
| Change at Week 16: TS |
0.1
(3.20)
|
| Change at Week 16: DR |
0.1
(1.33)
|
| Change at Week 24: TS |
-0.0
(3.78)
|
| Change at Week 24: DR |
0.1
(1.25)
|
| Change at Week 32: TS |
0.6
(3.53)
|
| Change at Week 32: DR |
0.3
(1.29)
|
| Change at Week 40: TS |
1.1
(3.56)
|
| Change at Week 40: DR |
0.4
(1.27)
|
| Change at Week 48: TS |
0.2
(3.82)
|
| Change at Week 48: DR |
0.2
(1.59)
|
| Change at Week 56: TS |
-0.0
(3.83)
|
| Change at Week 56: DR |
0.2
(1.47)
|
| Change at Week 64: TS |
1.1
(3.81)
|
| Change at Week 64: DR |
1.4
(2.09)
|
| Change at Week 72: TS |
1.2
(4.15)
|
| Change at Week 72: DR |
0.2
(0.45)
|
| Change at End of Study: TS |
0.3
(3.48)
|
| Change at End of Study: DR |
0.2
(1.25)
|
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. | |
| Arm/Group Title | Tanezumab 50 mcg/kg | |
| Arm/Group Description | Participants who had previously received either tanezumab (RN624 or PF-04383119) 10, 25, 50, 100 or 200 microgram per kilogram (mcg/kg) intravenous infusion or placebo matched to tanezumab infusion in parent study A4091008 (NCT00394563), received tanezumab 50 mcg/kg intravenous infusion over 5 minutes at Day 1 and 56. Additional doses of tanezumab 50 mcg/kg intravenous infusion over 5 minutes at 8 week intervals from Day 56 as per investigator's discretion. | |
All Cause Mortality |
||
| Tanezumab 50 mcg/kg | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Tanezumab 50 mcg/kg | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/281 (2.8%) | |
| Cardiac disorders | ||
| Myocardial infarction | 1/281 (0.4%) | |
| Gastrointestinal disorders | ||
| Upper gastrointestinal haemorrhage | 1/281 (0.4%) | |
| Injury, poisoning and procedural complications | ||
| Joint dislocation | 1/281 (0.4%) | |
| Radius fracture | 1/281 (0.4%) | |
| Upper limb fracture | 1/281 (0.4%) | |
| Musculoskeletal and connective tissue disorders | ||
| Intervertebral disc protrusion | 1/281 (0.4%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Malignant melanoma | 1/281 (0.4%) | |
| Multiple myeloma | 1/281 (0.4%) | |
| Nervous system disorders | ||
| Migraine | 1/281 (0.4%) | |
| Spinal cord ischaemia | 1/281 (0.4%) | |
Other (Not Including Serious) Adverse Events |
||
| Tanezumab 50 mcg/kg | ||
| Affected / at Risk (%) | # Events | |
| Total | 112/281 (39.9%) | |
| General disorders | ||
| Oedema peripheral | 10/281 (3.6%) | |
| Infections and infestations | ||
| Nasopharyngitis | 12/281 (4.3%) | |
| Sinusitis | 10/281 (3.6%) | |
| Upper respiratory tract infection | 13/281 (4.6%) | |
| Urinary tract infection | 11/281 (3.9%) | |
| Injury, poisoning and procedural complications | ||
| Contusion | 7/281 (2.5%) | |
| Fall | 6/281 (2.1%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 19/281 (6.8%) | |
| Back pain | 17/281 (6%) | |
| Joint effusion | 13/281 (4.6%) | |
| Joint swelling | 11/281 (3.9%) | |
| Musculoskeletal pain | 6/281 (2.1%) | |
| Osteoarthritis | 8/281 (2.8%) | |
| Pain in extremity | 7/281 (2.5%) | |
| Synovial cyst | 8/281 (2.8%) | |
| Nervous system disorders | ||
| Dizziness | 8/281 (2.8%) | |
| Headache | 16/281 (5.7%) | |
| Hypoaesthesia | 9/281 (3.2%) | |
| Paraesthesia | 7/281 (2.5%) | |
Limitations/Caveats
Data for rescue medication was recorded on the concomitant medication page of the case report form (CRF) as 'pro re nata (as needed)' rather than 'as pill counts'; hence total daily dose of rescue medication received was not recorded.
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:
NCT00399490
Other Study ID Numbers:
- A4091009
- RN624-CL007
First Posted:
Nov 15, 2006
Last Update Posted:
Feb 2, 2021
Last Verified:
Nov 1, 2020