Osteoarthritis, KneePhase 2NCT00994890
A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections
A Phase 2 study testing Tanezumab 2.5 mg, Tanezumab 5 mg and Tanezumab 10 mg in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Pfizer at 100 sites in United States.
Trial summary
This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Tanezumab 2.5 mg, Tanezumab 5 mg and Tanezumab 10 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 679 participants
- Where
- 100 sitesUnited States
- Study dates
- 17 Nov 2009to 1 Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);
Who cannot join
- Body mass index (BMI) of >39 kg/m2;
- Pregnancy or intent to become pregnant
- Planned surgical procedure during the duration of the study
- History of clinically significant cardiovascular, central nervous system or psychiatric disease
- Previous exposure to exogenous NGF or to an anti NGF antibody;
- Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions
Trial locations and contacts
100 sites in 1 country.
100 sites in 1 country
United States100 sites
Anderson Radiology
Anderson, South Carolina, 29621
Primary Care Associates
Anderson, South Carolina, 29621
Radiant Research, Inc.
Anderson, South Carolina, 29621
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801
RASF Clinical Research Center
Boca Raton, Florida, 33486
Boston Clinical Trails, Inc.
Boston, Massachusetts, 02135
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
Arthritis and Rheumatic Disease Associates, PC
Burke, Virginia, 22015
Office of John M. Joseph, M.D.
Carrollton, Texas, 75007
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207
Radiant Research, Inc
Chicago, Illinois, 60654
Woodrail Clinic
Columbia, Missouri, 65203
University Physicians
Columbia, Missouri, 65212
Radiant Research, Inc
Columbus, Ohio, 43212
Medvin Clinical Research
Covina, California, 91723
Arthritis Care and Diagnostic Center
Dallas, Texas, 75231
Physicians' Research Options, LLC
Draper, Utah, 84020
Lone Peak Family Medicine
Draper, Utah, 84070
Robert A. Harrell, MD
Durham, North Carolina, 27704
Integrated Medical Group PC/Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522
Ft. Smith Rheumatology, PC
Fort Smith, Arkansas, 72903
Arthritis Center of North Georgia
Gainesville, Georgia, 30501
Sarah Cannon Research Institute, LLC
Germantown, Tennessee, 38138
Wolf River Medical Group. LLC
Germantown, Tennessee, 38138
Internal Medical Associates of Grand Island, PC
Grand Island, Nebraska, 68803
Houston Medical Research Associates
Houston, Texas, 77090
Nothwest Diagonstic Clinic, PA
Houston, Texas, 77090
The Jackson Clinic, PA
Jackson, Tennessee, 38305
Richard Neiman, MD Inc.
Kirkland, Washington, 98034
Research Across America @ Oyster Point Family Health Center
Lancaster, Pennsylvania, 17601
Radiant Research, Inc
Las Vegas, Nevada, 89146
Sunrise Medical Research
Lauderdale Lake, Florida, 33319
Kansas City Internal Medicine
Lee's Summit, Missouri, 64086
Kentucky Medical Research Center
Lexington, Kentucky, 40504
Larry Watkins, MD
Little Rock, Arkansas, 72205
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205
OrthoArkansas, PA
Little Rock, Arkansas, 72205
Radiology Consultants
Little Rock, Arkansas, 72205
Pacific Arthritis Care Center
Los Angeles, California, 90045
Melbourne Internal Medicine Associates
Melbourne, Florida, 32901
MIMA Century Research Associate
Melbourne, Florida, 32901
Osler Medical, Inc.
Melbourne, Florida, 32901
Aurora Advanced Healthcare
Milwaukee, Wisconsin, 53209
Montana Medical Research, Inc
Missoula, Montana, 59808
Mobile Diagnostic Center
Mobile, Alabama, 36608
Seton Medical Management, Inc.
Mobile, Alabama, 36608
Central Kentucky Research Associates
Mount Sterling, Kentucky, 40353
Mt. Sterling Clinic
Mount Sterling, Kentucky, 40353
Carolina Health Specialists
Myrtle Beach, South Carolina, 29572
Staywell Research
Northridge, California, 91325
University Imaging Centers
Northridge, California, 91325
Renstar Medical Research
Ocala, Florida, 344471
American Family Medical
Ocala, Florida, 34471
Renstar Medical Research
Ocala, Florida, 34471
Paddock Park Clinical Research
Ocala, Florida, 34474
McBride Clinic
Oklahoma City, Oklahoma, 73103
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
South Puget Sound Clinical Research Center
Olympia, Washington, 98502
Medical Research Group of Central Florida
Orange City, Florida, 32763
Buffalo Rheumatology
Orchard Park, New York, 14127
Radiant Research, Inc
Overland Park, Kansas, 66202
Pensacola Research Consultants, Inc.
Pensacola, Florida, 32504
Methodist Medical Group Rheumatology
Peoria, Illinois, 61602
Methodist Research Administration Office
Peoria, Illinois, 61602
Clinical Research Source, Inc.
Perrysburg, Ohio, 43551
Arthritis Group
Philadelphia, Pennsylvania, 19152
Phoenix Rheumatology Specialists, Ltd.
Phoenix, Arizona, 85006
Radiant Research, Inc
Pinellas Park, Florida, 33781
Jarred Frydman, DO
Plantation, Florida, 33324
Orthopaedic Center of South Flordia
Plantation, Florida, 33324
Advanced Medical Research
Port Orange, Florida, 32127
Arthritis Clinic
Racine, Wisconsin, 53406
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
Alan E. Schulman, MD
Richmond, Virginia, 23226
Steven Maestrello, M.D.
Richmond, Virginia, 23294
Rockford Health Physicians
Rockford, Illinois, 61103-3692
Arthritis & Osteoporosis Center of South Texas
San Antonio, Texas, 78232
C Michael Neuwelt, MD
San Leandro, California, 94578
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454
Radiant Research, Inc
Scottsdale, Arizona, 85251
Advanced Arthritis Care and Research
Scottsdale, Arizona, 85258
Center for Arthritis and Rheumatic Diseases
South Miami, Florida, 33143
Clayton Medical Research
St Louis, Missouri, 63117
Advance Clinical Research Inc
St Louis, Missouri, 63128
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
Barbara A. Caciolo
St Louis, Missouri, 63139
Texas Research Center, LP
Sugar Land, Texas, 77479
Tampa Medical Group, P.A.
Tampa, Florida, 33614
Bone Joint & Spine Surgeons, Inc.
Toledo, Ohio, 43623
Catalina Pointe Clinical Research, Inc
Tucson, Arizona, 85704
Healthcare Research Consultants
Tulsa, Oklahoma, 74135
Trinity Clinic, Office of Research Administration
Tyler, Texas, 75701
Trinity Clinic, Rheumatology
Tyler, Texas, 75701
Granger Medical Clinic
West Valley City, Utah, 84120
Allegheny North Arthritis Center
Wexford, Pennsylvania, 15090
Medvin Clinical Research
Whittier, California, 90606
Upstate Clinical Research Associates
Williamsville, New York, 14221
Piedmont Imaging
Winston-Salem, North Carolina, 27103
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
Jeffry A. Lindenbaum D.O., P.C.
Yardley, Pennsylvania, 19067
About this study
Official title: A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND,LONG TERM STUDY OF THE SAFETY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.
Read the detailed description
Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 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.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Tanezumab 2.5 mg, Tanezumab 5 mg, Tanezumab 10 mg
- Keywords
- Double-blind safety
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tanezumab 2.5 mgDrug
Also called Biological
Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
Tanezumab 5 mgDrug
Also called Biological
Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
Tanezumab 10 mgDrug
Also called Biological
Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
| Study group | Role | What they receive |
|---|---|---|
| Tanezumab 2.5 mg | Experimental | Not described Receives: Drug: Tanezumab 2.5 mg |
| Tanezumab 5 mg | Experimental | Not described Receives: Drug: Tanezumab 5 mg |
| Tanezumab 10 mg | Experimental | Not described Receives: Drug: Tanezumab 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: Baseline up to 112 days after last dose of study medication (up to 345 days)
Number of Participants With Laboratory Abnormalities
Laboratory analysis included blood chemistry, hematology, urinalysis and pregnancy test.
Measured: Baseline to Week 50
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as adverse events were presented.
Measured: Baseline up to Week 50
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Measured: Baseline, Week 2
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Measured: Baseline, Week 4
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Measured: Baseline, Week 8
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Measured: Baseline, Week 16
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Measured: Baseline, Week 24
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Measured: Baseline, Week 32
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Measured: Baseline, Week 40
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Measured: Baseline, Week 48
Number of Participants With Clinically Significant Change From Baseline in Physical Findings
Physical examination included examination of abdomen, ears, extremities, eyes, head, heart, lungs, lymph nodes, neck, nose, skin, throat, thyroid, muscoskeletal, neurological and peripheral vascular system.
Measured: Baseline to Week 50
Number of Participants With Anti-Drug Antibody (ADA) at Day 1
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
Measured: Day 1
Number of Participants With Anti-Drug Antibody (ADA) at Week 8
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
Measured: Week 8
Number of Participants With Anti-Drug Antibody (ADA) at Week 24
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
Measured: Week 24
Number of Participants With Anti-Drug Antibody (ADA) at Week 50
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
Measured: Week 50
Number of Participants With Vital Sign Abnormalities
Examination of vital signs included body temperature, systolic blood pressure, diastolic blood pressure, pulse rate and respiratory rate. Participants with abnormal vital sign findings reported as adverse events were presented.
Measured: Baseline up to Week 50
Number of Participants With Injection-Site Reactions at Day 1
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Measured: Day 1
Number of Participants With Injection-Site Reactions at Week 2
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Measured: Week 2
Number of Participants With Injection-Site Reactions at Week 4
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Measured: Week 4
Number of Participants With Injection-Site Reactions at Week 8
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Measured: Week 8
Number of Participants With Injection-Site Reactions at Week 16
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Measured: Week 16
Number of Participants With Injection-Site Reactions at Week 24
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Measured: Week 24
Number of Participants With Injection-Site Reactions at Week 32
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Measured: Week 32
Number of Participants With Injection-Site Reactions at Week 40
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Measured: Week 40
Secondary outcomes (15)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It was calculated as mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 to 10, where higher scores indicated higher pain.
Measured: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint and index hip during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on NRS of 0 to 10, with higher scores indicated worse function. Total score range for WOMAC physical function subscale score was 0 to 10, where higher scores indicated worse function.
Measured: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56
Participants answered: "Considering all the ways your osteoarthritis in your knee (or hip) affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities).
Measured: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit 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).
Measured: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Percentage of participants with at least 30%, 50%, 70% and 90% reduction from baseline in WOMAC pain subscale score are reported. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It was calculated as mean of the scores from the 5 individual questions scored on a 0 to 10 NRS, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicated higher pain.
Measured: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or index hip during past 48 hours. It is calculated as mean of the scores from 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. Participants with specified reduction (as percent) from baseline at Week 16 are reported.
Measured: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis
Participants answered: "Considering all the ways your osteoarthritis in your knee (or hip) affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value.
Measured: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or index hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of 0 to 10, with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee or hip.
Measured: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
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. Each item was scored on a 0 to 10 NRS scale, where higher scores indicated higher pain/stiffness or worse function. WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranged from 0 to 10, where higher score indicated worse response.
Measured: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.
Measured: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
Participants answered: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.
Measured: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56
Time to Discontinuation Due to Lack of Efficacy
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Measured: Baseline up to Week 50
Number of Participants Who Discontinued Due to Lack of Efficacy
Measured: Baseline up to Week 50
Percentage of Participants Who Used Concomitant Analgesic Medication
United States Food and Drug Administration (FDA) approved analgesics were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), capsaicin products and viscosupplementation (example, hyaluronan) and were prescribed at the discretion of the Investigator.
Measured: Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64
Days Per Week of Concomitant Analgesic Medication Usage
United States FDA-approved analgesics were permitted as concomitant medications to relieve the pain of OA. These medications included opioids, topical analgesics, NSAIDs, capsaicin products and viscosupplementation (example, hyaluronan) and were prescribed at the discretion of the Investigator.
Measured: Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study start17 Nov 2009
- Primary completion7 Dec 2010
- Study completion1 Mar 2011
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994890
- Sponsor's protocol ID
- A4091043
- Other IDs
- SC OA SAFETY STUDY
- Status last verified
- Apr 2021
- First submitted
- 12 Oct 2009
- Last updated
- 13 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND,LONG TERM STUDY OF THE SAFETY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
- ClinicalTrials.gov ID
- NCT00994890
- Acronym / sponsor ID
- A4091043
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Double-blind safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 679 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2009 (actual)
- Primary completion
- 7 Dec 2010 (actual)
- Study completion
- 1 Mar 2011 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Posted 13 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.
Detailed description
Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tanezumab 2.5 mg | Experimental | Drug: Tanezumab 2.5 mg |
| Tanezumab 5 mg | Experimental | Drug: Tanezumab 5 mg |
| Tanezumab 10 mg | Experimental | Drug: Tanezumab 10 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);
Key exclusion criteria (6 listed)
- Body mass index (BMI) of >39 kg/m2;
- Pregnancy or intent to become pregnant
- Planned surgical procedure during the duration of the study
- History of clinically significant cardiovascular, central nervous system or psychiatric disease
- Previous exposure to exogenous NGF or to an anti NGF antibody;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tanezumab 2.5 mgAlso: BiologicalTanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year | Drug | Tanezumab 2.5 mg |
| Tanezumab 5 mgAlso: BiologicalTanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year | Drug | Tanezumab 5 mg |
| Tanezumab 10 mgAlso: BiologicalTanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year | Drug | Tanezumab 10 mg |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to 112 days after last dose of study medication (up to 345 days)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Laboratory Abnormalities
Time frame: Baseline to Week 50
Laboratory analysis included blood chemistry, hematology, urinalysis and pregnancy test.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Time frame: Baseline up to Week 50
All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as adverse events were presented.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2
Time frame: Baseline, Week 2
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4
Time frame: Baseline, Week 4
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8
Time frame: Baseline, Week 8
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16
Time frame: Baseline, Week 16
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24
Time frame: Baseline, Week 24
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32
Time frame: Baseline, Week 32
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40
Time frame: Baseline, Week 40
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48
Time frame: Baseline, Week 48
NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.
Number of Participants With Clinically Significant Change From Baseline in Physical Findings
Time frame: Baseline to Week 50
Physical examination included examination of abdomen, ears, extremities, eyes, head, heart, lungs, lymph nodes, neck, nose, skin, throat, thyroid, muscoskeletal, neurological and peripheral vascular system.
Number of Participants With Anti-Drug Antibody (ADA) at Day 1
Time frame: Day 1
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
Number of Participants With Anti-Drug Antibody (ADA) at Week 8
Time frame: Week 8
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
Number of Participants With Anti-Drug Antibody (ADA) at Week 24
Time frame: Week 24
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
Number of Participants With Anti-Drug Antibody (ADA) at Week 50
Time frame: Week 50
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.
Number of Participants With Vital Sign Abnormalities
Time frame: Baseline up to Week 50
Examination of vital signs included body temperature, systolic blood pressure, diastolic blood pressure, pulse rate and respiratory rate. Participants with abnormal vital sign findings reported as adverse events were presented.
Number of Participants With Injection-Site Reactions at Day 1
Time frame: Day 1
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Number of Participants With Injection-Site Reactions at Week 2
Time frame: Week 2
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Number of Participants With Injection-Site Reactions at Week 4
Time frame: Week 4
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Number of Participants With Injection-Site Reactions at Week 8
Time frame: Week 8
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Number of Participants With Injection-Site Reactions at Week 16
Time frame: Week 16
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Number of Participants With Injection-Site Reactions at Week 24
Time frame: Week 24
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Number of Participants With Injection-Site Reactions at Week 32
Time frame: Week 32
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Number of Participants With Injection-Site Reactions at Week 40
Time frame: Week 40
Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
15 secondary outcomes
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
Time frame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
Time frame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56
Time frame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
Time frame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
Time frame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56
Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
Time frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56
Time to Discontinuation Due to Lack of Efficacy
Time frame: Baseline up to Week 50
Number of Participants Who Discontinued Due to Lack of Efficacy
Time frame: Baseline up to Week 50
Percentage of Participants Who Used Concomitant Analgesic Medication
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64
Days Per Week of Concomitant Analgesic Medication Usage
Time frame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
100 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tanezumab 2.5 mg, Tanezumab 5 mg and Tanezumab 10 mg in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Pfizer at 100 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: Baseline up to 112 days after last dose of study medication (up to 345 days)). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.