Clincosm LogoSign in Get a demo

Extension Study Of Tanezumab In Osteoarthritis

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00809783
Collaborator
(none)
2,147
Enrollment
226
Locations
3
Arms
28.5
Actual Duration (Months)
9.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab

Condition or Disease Intervention/Treatment Phase
  • Biological: tanezumab
  • Biological: tanezumab
  • Biological: tanezumab
 Phase 3

Detailed Description

This study was terminated on 27 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Study Design

Study Type:
Interventional
Actual Enrollment :
2147 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Actual Study Start Date :
Feb 6, 2009
Actual Primary Completion Date :
Nov 2, 2010
Actual Study Completion Date :
Jun 23, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tanezumab 10 mg

Tanezumab 10 mg

Biological: tanezumab
Tanezumab 10 mg
Other Names:
  • RN624

    		•
    Experimental: Tanezumab 5 mg

    Tanezumab 5 mg

    Biological: tanezumab
    Tanezumab 5 mg
    Other Names:
  • RN624

    		•
    Experimental: Tanezumab 2.5 mg

    Tanezumab 2.5 mg

    Biological: tanezumab
    Tanezumab 2.5 mg
    Other Names:
  • RN624

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) [A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)]

      AE:any untoward medical occurrence in participant who received study medication 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 medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.

    2. Number of Participants With Abnormal Laboratory Findings [A4091016: Day 1 up to Week 80]

      Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN),MCV,MCH,MCHC<0.9*LLN or >1.1*ULN,platelet:<0.5*LLN or >1.75*upper limit of normal(ULN),white blood cell(WBC):<0.6*LLN or >1.5*ULN,lymphocyte,neutrophil,total neutrophil:<0.8*LLN or>1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN;total,direct bilirubin>1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;cholesterol,triglycerides>1.3*ULN;sodium <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN,phosphate<0.8*LLN or>1.2*ULN;glucose <0.6*LLN or >1.5*ULN,glycosylated Hgb >1.3*ULN,creatine kinase>2.0*ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5*ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20).

    3. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings [A4091016: Baseline (Day 1) up to Week 80]

      Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and VR interval. Number of participants with clinically significant abnormal ECG findings were judged by investigator and reported as adverse events were presented.

    Secondary Outcome Measures

    1. Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72 [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72]

      NIS constitutes sum of 37 standard items of neuromuscular examination used to assess muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) scored on a scale: 0 (normal) to 4 (paralysis), with higher score=more weakness; components of reflexes and sensation (13 items) scored on a scale: 0= normal, 1= decreased or 2= absent. Total NIS score range 0 (no impairment) to 244 (maximum impairment), higher score = more impairment. Parent study baseline value calculated as average of pre-dose measurements of participants from study A4091011, A4091014, A4091015 and A4091018.

    2. Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab [A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)]

      Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.

    3. Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings [Baseline (Day 1) up to Week 80]

      Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat and thyroid. Clinically significant changes were judged by investigator.

    4. Number of Participants With Clinically Significant Abnormality in Vital Signs [A4091016: Baseline (Day 1) up to Week 80]

      Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs were judged by investigator and reported as adverse events were presented.

    5. Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104]

      The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

    6. Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104]

      The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC physical function score is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

    7. Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104]

      Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicate worse condition. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

    8. Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response [A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104]

      OMERACT-OARSI response:>=50 percent(%) improvement from parent study baseline and absolute change from parent study baseline of >=2 units at given week in WOMAC pain or physical function subscale or >=20% improvement from parent study baseline and absolute change from parent study baseline of >=1 unit at given week in at least 2 of following 3 items: 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).

    9. Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104]

      The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

    10. Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104 [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104]

      The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

    11. Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104]

      Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicated worse pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

    12. Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104]

      WOMAC stiffness subscale: questionnaire used to assess amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. The WOMAC stiffness score is calculated as mean of scores from 2 individual questions scored on NRS of 0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score =0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Stiffness is defined as sensation of decreased ease in movement of knee/hip. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

    13. Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104]

      WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (minimum difficulty) to 10 (maximum difficulty), where higher score indicates worse response. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

    14. Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104]

      Participants answered: "How much pain have you had going up or down the stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

    15. Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104 [Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104]

      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. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

    16. Percentage of Participants Who Used Concomitant Analgesic Medication [Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112]

      United States Food and Drug Administration (FDA) approved analgesics (over-the-counter or prescription) 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, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed as per investigator's discretion.

    17. Days Per Week of Concomitant Analgesic Medication Usage [Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112]

      FDA approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, NSAIDs, capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed at the discretion of the investigator.

    Other Outcome Measures

    1. Number of Participants Classified According to Number of Intravenous Doses of Study Medication [A4091016: Baseline (Day 1) up to Week 64]

      Number of participants were reported based on the maximum number of intravenous doses of either tanezumab or placebo received.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis
    Exclusion Criteria:
    • Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pinncale Research Group, LLC Anniston Alabama United States 36201
    2 Anniston Medical Clinic, PC Anniston Alabama United States 36207
    3 Pinnacle Research Group, LLC Anniston Alabama United States 36207
    4 Greystone Medical Center Birmingham Alabama United States 35242
    5 Saadat Ansari, MD Office Huntsville Alabama United States 35801
    6 Coastal Clinical Research, Inc. Mobile Alabama United States 36608
    7 Horizon Research Group Mobile Alabama United States 36608
    8 Clinical Research Advantage, Inc./Mesa Family Medical Center, PC Mesa Arizona United States 85203
    9 Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC Mesa Arizona United States 85206
    10 Novara Clinical Research Mesa Arizona United States 85206
    11 Clinical Research Advantage, Inc. Mesa Arizona United States 85213
    12 Arizona Arthritis & Rheumatology Research, PLLC Paradise Valley Arizona United States 85253
    13 Pivotal Research Center Peoria Arizona United States 85381
    14 Clincial Research Advantage, Inc/Central Phoenix Medical Clinic, LLC Phoenix Arizona United States 85020
    15 Arizona Research Center Phoenix Arizona United States 85023
    16 Clinical Research Advantage, Inc. Phoenix Arizona United States 85028
    17 Arizona Arthritis & Rheumatology Associates, P.C. Phoenix Arizona United States 85037
    18 Paradigm Clinical, Inc. Tucson Arizona United States 85712
    19 Quality of Life Medical & Research Center, LLC Tucson Arizona United States 85712
    20 Quality of Life Medical and Research Center Tucson Arizona United States 85712
    21 Tucson Orthopaedic Institute Tucson Arizona United States 85712
    22 University of Arizona Tucson Arizona United States 85724
    23 St. Joseph's Mercy Clinic Hot Springs Arkansas United States 71913
    24 Osteoporosis Medical Center Beverly Hills California United States 90211
    25 Providence Clinical Research Burbank California United States 91505
    26 eStudySite Chula Vista California United States 91911
    27 Colorado Hematology - Oncology Englewood California United States 80110
    28 Colorado Orthopedic Consultants, PC Englewood California United States 80110
    29 Arthritis Medical Clinic of North County, Inc. Escondido California United States 92025
    30 Edinger Medical Group Clinical Research Fountain Valley California United States 92708
    31 Valley Research Fresno California United States 93720
    32 Talbert Medical Group Huntington Beach California United States 92646
    33 Lakewood Orthopedic Medical & Surgical Group Lakewood California United States 90712
    34 High Desert Medical Group Research for Life Lancaster California United States 93534
    35 Premiere Clinical Research, LLC Long Beach California United States 90807
    36 Samaritan Center for Medical Research Los Gatos California United States 95032
    37 Del Carmen Medical Center Reseda California United States 91335
    38 Probe Clinical Research, Corp. Santa Ana California United States 92701
    39 Trinity Clinical Trials Santa Ana California United States 92701
    40 Office of Lawrence P McAdam, MD Thousand Oaks California United States 91360
    41 Westlake Medical Research Westlake Village California United States 91361
    42 Colorado Orthopedic Consultants, PC Aurora Colorado United States 80012
    43 Peak Anesthesia and Pain Management Centennial Colorado United States 80112
    44 Denver Internal Medicine Group Denver Colorado United States 80209
    45 Mountain View Clinical Research, Inc. Denver Colorado United States 80209
    46 Advanced Orthopedic and Sports Medicine Denver Colorado United States 80230
    47 American Clinical Research, LLC Englewood Colorado United States 80113
    48 Orthopaedic Physicians Of Colorado, P.C. Englewood Colorado United States 80113
    49 University Parks Hematology/Oncology Englewood Colorado United States 80113
    50 Advanced Orthopedic and Sports Medicine Parker Colorado United States 80134
    51 Clinical Research Center of Connecticut Danbury Connecticut United States 06810
    52 Norwalk Medical Group Norwalk Connecticut United States 06851
    53 Stamford Therapeutics Consortium Stamford Connecticut United States 06905
    54 Delaware Arthritis Lewes Delaware United States 19958
    55 Javed Rheumatology Associates, Inc. Newark Delaware United States 19713
    56 HeartCare (Private Practice) Bradenton Florida United States 34202
    57 Innovative Research of West Florida, Inc. Clearwater Florida United States 33756
    58 Tampa Bay Medical Research, Inc. Clearwater Florida United States 33761
    59 Clinical Research of South Florida Coral Gables Florida United States 33134
    60 Avail Clinical Research, LLC DeLand Florida United States 32720
    61 Arthritis Associates of South Florida Delray Beach Florida United States 33484
    62 Delray Research Associates Delray Beach Florida United States 33484
    63 In Vivo Clinical Research, Inc Doral Florida United States 33166
    64 S & W Clinical Research Fort Lauderdale Florida United States 33306
    65 Centre for Rheumatology, Immunology and Arthritis Fort Lauderdale Florida United States 33334
    66 Westside Center for Clinical Research Jacksonville Florida United States 32205
    67 Adult Medicine Specialists Longwood Florida United States 32779
    68 Genesis Research International Longwood Florida United States 32779
    69 Pharmax Research Clinic, Inc Miami Florida United States 33126
    70 Kendall South Medical Center, Inc. Miami Florida United States 33185
    71 Sunshine Research Center Opa-locka Florida United States 33054-3818
    72 Compass Research, LLC Orlando Florida United States 32806
    73 Rheumatology Associates of Central Florida Orlando Florida United States 32806
    74 The Arthritis Center Palm Harbor Florida United States 34684
    75 University Clinical Research Incorporated Pembroke Pines Florida United States 33024
    76 Advent Clinical Research Centers, Inc. Pinellas Park Florida United States 33781
    77 Progressive Medical Research Port Orange Florida United States 32127
    78 Dale G. Bramlet, MD, P.L. Saint Petersburg Florida United States 33713
    79 HeartCare Research Sarasota Florida United States 34232
    80 West Broward Rheumatology Associates, Inc. Tamarac Florida United States 33321
    81 Tampa Medical Group, PA Tampa Florida United States 33614
    82 Palm Beach Research Center West Palm Beach Florida United States 33409
    83 Laureate Clinical Research Group Atlanta Georgia United States 30308
    84 Arthritis and Rheumatology of Georgia Atlanta Georgia United States 30342
    85 Laureate Clinical Research Group Atlanta Georgia United States 30342
    86 Masters of Clinical Research, Inc. Augusta Georgia United States 30909
    87 River Birch Research Alliance, LLC Blue Ridge Georgia United States 30513
    88 Jefrey D. Lieberman, MD Decatur Georgia United States 30033
    89 Early Family Practice Center Fort Valley Georgia United States 31030
    90 Northeast Georgia Diagnostic Clinic, LLC Gainesville Georgia United States 30501
    91 Marietta Rheumatology Associates Marietta Georgia United States 30060
    92 North Georgia Clinical Research Woodstock Georgia United States 30189
    93 North Georgia Internal Medicine Woodstock Georgia United States 30189
    94 Sonora Clinical Research, LLC. Boise Idaho United States 83702
    95 Millennium Pain Center Bloomington Illinois United States 61701
    96 Rehabilitation Institute of Chicago Chicago Illinois United States 60611
    97 Illinois Bone and Joint Institute, LLC Morton Grove Illinois United States 60053
    98 Koch Family Medicine Morton Illinois United States 61550
    99 The Arthritis Center Springfield Illinois United States 62704
    100 MediSphere Medical Research Center, LLC Evansville Indiana United States 47714
    101 American Health Network Fishers Indiana United States 46038
    102 Memorial Medical Group Clinical Research Institute South Bend Indiana United States 46601
    103 Northwest Indiana Center for Clinical Research Valparaiso Indiana United States 46383
    104 McFarland Clinic, PC Ames Iowa United States 50010
    105 Integrated Clinical Trial Services, Inc. West Des Moines Iowa United States 50265
    106 Professional Research Network of Kansas, LLC Wichita Kansas United States 67203
    107 Pasadena Pharmacy Lexington Kentucky United States 40503
    108 The Pain Treatment Center of the Bluegrass Lexington Kentucky United States 40503
    109 Arthritis Center of Lexington Lexington Kentucky United States 40504
    110 Bluegrass Community Research, Inc Lexington Kentucky United States 40515
    111 David H. Neustadt, MD Louisville Kentucky United States 40202
    112 L-Marc Research Center Louisville Kentucky United States 40213
    113 Bone and Joint Clinic of Baton Rouge Baton Rouge Louisiana United States 70808
    114 Gulf Coast Research, LLC Baton Rouge Louisiana United States 70808
    115 The Baton Rouge Clinic Baton Rouge Louisiana United States 70808
    116 Stanocola Medical Center Baton Rouge Louisiana United States 70816
    117 Arthritis and Diabetes Clinic Monroe Louisiana United States 71203
    118 Maine Research Associates Auburn Maine United States 04210
    119 Arthritis Treatment Center Frederick Maryland United States 21702
    120 Mid-Atlantic Medical Research Centers Hollywood Maryland United States 20636
    121 The Center for Rheumatology and Bone Research Wheaton Maryland United States 20902
    122 Beacon Clinical Research, LLC Brockton Massachusetts United States 02301
    123 Miray Medical Center Brockton Massachusetts United States 02301
    124 Mansfield Health Center Mansfield Massachusetts United States 02048
    125 Arthritis Associates Inc. Peabody Massachusetts United States 01960
    126 Clinical Pharmacology Study Group Worcester Massachusetts United States 01610
    127 Ann Arbor Clinical Research Ann Arbor Michigan United States 48103
    128 Great Lakes Research Group, Incorporated Bay City Michigan United States 48706
    129 KMED Research Saint Clair Shores Michigan United States 48081
    130 MAPS Applied Research Center Inc. Edina Minnesota United States 55435
    131 Medical Advanced Pain Specialists Edina Minnesota United States 55435
    132 Planters Clinic Port Gibson Mississippi United States 39150
    133 Medex Healthcare Research Saint Louis Missouri United States 63117
    134 Mercy Health Research Saint Louis Missouri United States 63141
    135 St. John's Clinic - Neurology Springfield Missouri United States 65804
    136 St. John's Medical Research Institute, Inc. Springfield Missouri United States 65807
    137 Midwest Minor Medical Omaha Nebraska United States 68114
    138 Quality Clinical Research, Inc. Omaha Nebraska United States 68114
    139 Midwest Minor Medical Omaha Nebraska United States 68127
    140 Midwest Minor Medical Omaha Nebraska United States 68144
    141 Diagnostic Center of Medicine Henderson Nevada United States 89052
    142 Independent Clinical Researchers Las Vegas Nevada United States 89103
    143 Wolfson Medical Center Las Vegas Nevada United States 89103
    144 Clinical Research Consortium Las Vegas Nevada United States 89119
    145 Mirkil Medical Las Vegas Nevada United States 89119
    146 G. Timothy Kelly, MD Las Vegas Nevada United States 89128
    147 Office of Dr. Danka Michaels, MD Las Vegas Nevada United States 89128
    148 Comprehensive Clinical Research Berlin New Jersey United States 08009
    149 Albuquerque Clinical Trials Albuquerque New Mexico United States 87102
    150 New Mexico Clinical Research & Osteoporosis Center, Incorporated Albuquerque New Mexico United States 87106
    151 SPRI Bronx LLC Bronx New York United States 10454
    152 Arthritis and Osteoporosis Medical Associates Brooklyn New York United States 11201
    153 Medex Healthcare Research New York New York United States 10022
    154 The Medical Research Network, LLC New York New York United States 10128
    155 Prem C. Chatpar, MD, LLC Plainview New York United States 11803
    156 AAIR Research Center Rochester New York United States 14618
    157 Office of Dr. Andrew Porges Roslyn New York United States 11576-1507
    158 Arthritis and Osteoporosis Consultants of the Carolinas Charlotte North Carolina United States 28207-1198
    159 Carolina Bone & Joint, PA Charlotte North Carolina United States 28210
    160 Pharmquest Greensboro North Carolina United States 27408
    161 PMG Research of Winston-Salem Winston-Salem North Carolina United States 27103
    162 Odyssey Research Fargo North Dakota United States 58104
    163 Plains Medical Clinic, LLC Fargo North Dakota United States 58104
    164 Consultants for Clinical Research Incorporated Cincinnati Ohio United States 45219
    165 Ohio GI and Liver Institute Cincinnati Ohio United States 45219
    166 Hilltop Medical Research Center Cincinnati Ohio United States 45224
    167 Columbus Clinical Research, Inc. Columbus Ohio United States 43213
    168 PHP Center for Clinical Research Dayton Ohio United States 45439
    169 Paramount Medical Research and Consulting, LLC Middleburg Heights Ohio United States 44130
    170 Orthopaedic & Sports Medicine Consultants Middletown Ohio United States 45042
    171 Signal Point Clinical Research Center Middletown Ohio United States 45042
    172 Pharmacotherapy Research Associates,Inc Zanesville Ohio United States 43701
    173 Physicians' Research, Inc Zanesville Ohio United States 43701
    174 Primecare of Southeastern Ohio, Inc Zanesville Ohio United States 43701
    175 Cor Clinical Research, LLC Oklahoma City Oklahoma United States 73103
    176 Health Research Institute Oklahoma City Oklahoma United States 73109
    177 East Penn Rheumatology Associates, PC Bethlehem Pennsylvania United States 18015-1153
    178 Brandywine Clinical Research Downingtown Pennsylvania United States 19335-2620
    179 Altoona Center for Clinical Research Duncansville Pennsylvania United States 16635
    180 Clinical Research Center of Reading, LLP Wyomissing Pennsylvania United States 19610
    181 Low Country Rheumatology, PA Charleston South Carolina United States 29406
    182 The Family Healthcare Center, PA Clinton South Carolina United States 29325
    183 Southern Orthopaedic Sports Medicine Columbia South Carolina United States 29204
    184 Coastal Carolina Research Center Mount Pleasant South Carolina United States 29464
    185 The Carolina Center for Rheumatology and Arthritis Care, PA Rock Hill South Carolina United States 29732
    186 Health Concepts Rapid City South Dakota United States 57702
    187 State of Franklin Healthcare Associates, PLLC Johnson City Tennessee United States 37604
    188 Holston Medical Group Kingsport Tennessee United States 37660
    189 Capitol Medical Clinic Austin Texas United States 78705
    190 Walter F. Chase, MD, PA Austin Texas United States 78705
    191 Tekton Research, Inc. Austin Texas United States 78745
    192 North Texas Joint Care, PA Dallas Texas United States 75230
    193 Crown Imaging Dallas Texas United States 75231
    194 Metroplex Clinical Research Center Dallas Texas United States 75231
    195 Radiant Research Dallas Texas United States 75231
    196 O. David Taunton, Jr, MD Grapevine Texas United States 76051
    197 Asif Cochinwala, MD, PA Houston Texas United States 77008
    198 Foundation for Southwest Orthopedic Research Houston Texas United States 77030
    199 One Step Diagnostic Houston Texas United States 77030
    200 Southwest Orthopedic Group Houston Texas United States 77030
    201 The Neurology Center Houston Texas United States 77030
    202 Pioneer Research Solutions, Inc. Houston Texas United States 77036
    203 Gill Orthopedic Center Lubbock Texas United States 79410
    204 Robert R. King, M.D. Lubbock Texas United States 79410
    205 Clinical Investigations of Texas, LLC Plano Texas United States 75075
    206 Radiant Research San Antonio Northeast San Antonio Texas United States 78217
    207 Texas Arthritis Research Center, PA San Antonio Texas United States 78217
    208 Diagnostics Research Group San Antonio Texas United States 78229
    209 Spring Family Practice Associates PA Spring Texas United States 77379
    210 AZ Clinical Research Sugar Land Texas United States 77478
    211 Spring Clinical Research Sugar Land Texas United States 77478
    212 Sugar Land Med-Ped, P.A. Sugar Land Texas United States 77479
    213 Grayline Clinical Drug Trials Wichita Falls Texas United States 76309
    214 Aspen Clinical Research Orem Utah United States 84058
    215 Foothill Family Clinic Salt Lake City Utah United States 84109
    216 J. Lewis Research, Incorporated/Foothill Family Clinic South Salt Lake City Utah United States 84121
    217 Commonwealth Orthopaedics and Rehabilitation, PC Arlington Virginia United States 22205
    218 IntegraTrials, LLC Arlington Virginia United States 22205
    219 Virginia Hospital Center Arlington Virginia United States 22205
    220 Charlottesville Medical Research Charlottesville Virginia United States 22911
    221 National Clinical Research - Norfolk, Inc. Norfolk Virginia United States 23502
    222 Office of Doris M. Rice, MD, FACR Portsmouth Virginia United States 23701
    223 HhypotheTest, LLC Roanoke Virginia United States 24018
    224 Empirical Clinical Trials Selah Washington United States 98942
    225 Arthritis Northwest Spokane Washington United States 99204-2336
    226 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:
    NCT00809783
    Other Study ID Numbers:
    • A4091016
    • P3 LONG TERM SAFETY EXTENSION
    First Posted:
    Dec 17, 2008
    Last Update Posted:
    May 10, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Pfizer
    Tanezumab OA arthritis
    Additional relevant MeSH terms:
    Osteoarthritis
    Tanezumab

    Study Results

    Participant Flow

    Recruitment Details Participants randomized and treated with study medication in parent studies A4091011 (NCT00733902), A4091014 (NCT00744471), A4091015 (NCT00830063) and A4091018 (NCT00863304) who had completed the treatment period or discontinued due to lack of efficacy were eligible to enroll in this study.
    Pre-assignment Detail 533 participants who received placebo and 294 participants who received naproxen in parent studies were randomized to receive tanezumab 2.5, 5 or 10 milligram (mg) on Day 1. The remaining participants who received tanezumab in parent studies remained on the same dose they received in parent studies.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Period Title: Overall Study
    STARTED 525 832 790
    Treated 522 832 788
    COMPLETED 0 0 0
    NOT COMPLETED 525 832 790

    Baseline Characteristics

    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg Total
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Total of all reporting groups
    Overall Participants 522 832 788 2142
    Age, Customized (Count of Participants)
    18 to 44 years
    29
    5.6%
    43
    5.2%
    32
    4.1%
    104
    4.9%
    45 to 64 years
    298
    57.1%
    466
    56%
    455
    57.7%
    1219
    56.9%
    Greater than or equal to 65 years
    195
    37.4%
    323
    38.8%
    301
    38.2%
    819
    38.2%
    Sex: Female, Male (Count of Participants)
    Female
    308
    59%
    522
    62.7%
    474
    60.2%
    1304
    60.9%
    Male
    214
    41%
    310
    37.3%
    314
    39.8%
    838
    39.1%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
    Description AE:any untoward medical occurrence in participant who received study medication 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 medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
    Time Frame A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat (ITT) analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 522 832 788
    AEs
    363
    69.5%
    573
    68.9%
    547
    69.4%
    SAEs
    47
    9%
    73
    8.8%
    96
    12.2%
    2. Primary Outcome
    Title Number of Participants With Abnormal Laboratory Findings
    Description Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN),MCV,MCH,MCHC<0.9*LLN or >1.1*ULN,platelet:<0.5*LLN or >1.75*upper limit of normal(ULN),white blood cell(WBC):<0.6*LLN or >1.5*ULN,lymphocyte,neutrophil,total neutrophil:<0.8*LLN or>1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN;total,direct bilirubin>1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;cholesterol,triglycerides>1.3*ULN;sodium <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN,phosphate<0.8*LLN or>1.2*ULN;glucose <0.6*LLN or >1.5*ULN,glycosylated Hgb >1.3*ULN,creatine kinase>2.0*ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5*ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20).
    Time Frame A4091016: Day 1 up to Week 80

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783). "Overall number of participants analyzed" signifies those participants who were evaluable for this measure.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 516 810 767
    Count of Participants [Participants]
    439
    84.1%
    679
    81.6%
    624
    79.2%
    3. Primary Outcome
    Title Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
    Description Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and VR interval. Number of participants with clinically significant abnormal ECG findings were judged by investigator and reported as adverse events were presented.
    Time Frame A4091016: Baseline (Day 1) up to Week 80

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 522 832 788
    Count of Participants [Participants]
    14
    2.7%
    33
    4%
    17
    2.2%
    4. Secondary Outcome
    Title Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
    Description NIS constitutes sum of 37 standard items of neuromuscular examination used to assess muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) scored on a scale: 0 (normal) to 4 (paralysis), with higher score=more weakness; components of reflexes and sensation (13 items) scored on a scale: 0= normal, 1= decreased or 2= absent. Total NIS score range 0 (no impairment) to 244 (maximum impairment), higher score = more impairment. Parent study baseline value calculated as average of pre-dose measurements of participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

    Outcome Measure Data

    Analysis Population Description
    ITT population. Last observation carried forward (LOCF) method was used to impute missing values. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 522 832 785
    Parent Study Baseline
    1.06
    (3.16)
    0.95
    (2.55)
    1.09
    (3.08)
    Change at Week 4
    -0.10
    (0.97)
    -0.04
    (1.15)
    -0.12
    (1.91)
    Change at Week 8
    -0.04
    (1.60)
    -0.02
    (1.43)
    -0.03
    (1.72)
    Change at Week 16
    -0.07
    (1.51)
    -0.03
    (1.79)
    -0.07
    (2.00)
    Change at Week 24
    -0.09
    (1.65)
    -0.04
    (1.74)
    -0.12
    (1.82)
    Change at Week 32
    -0.05
    (1.44)
    -0.02
    (1.66)
    -0.05
    (1.79)
    Change at Week 40
    -0.01
    (2.57)
    0.02
    (1.62)
    -0.11
    (1.93)
    Change at Week 48
    -0.04
    (2.47)
    -0.03
    (1.54)
    -0.11
    (1.89)
    Change at Week 56
    -0.02
    (2.61)
    -0.04
    (1.56)
    -0.11
    (1.89)
    Change at Week 64
    -0.04
    (2.58)
    -0.07
    (1.59)
    -0.12
    (1.89)
    Change at Week 72
    -0.04
    (2.57)
    -0.05
    (1.59)
    -0.11
    (1.87)
    5. Secondary Outcome
    Title Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
    Description Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.
    Time Frame A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)

    Outcome Measure Data

    Analysis Population Description
    ITT population. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure at any time point. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 492 775 733
    Day 1
    0
    0%
    0
    0%
    0
    0%
    Week 16
    1
    0.2%
    1
    0.1%
    4
    0.5%
    Week 24
    0
    0%
    1
    0.1%
    3
    0.4%
    Week 40
    1
    0.2%
    0
    0%
    0
    0%
    Week 56
    2
    0.4%
    0
    0%
    1
    0.1%
    Week 72
    0
    0%
    0
    0%
    0
    0%
    Week 80 or ET
    2
    0.4%
    2
    0.2%
    5
    0.6%
    6. Secondary Outcome
    Title Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings
    Description Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat and thyroid. Clinically significant changes were judged by investigator.
    Time Frame Baseline (Day 1) up to Week 80

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 522 832 788
    Count of Participants [Participants]
    26
    5%
    48
    5.8%
    53
    6.7%
    7. Secondary Outcome
    Title Number of Participants With Clinically Significant Abnormality in Vital Signs
    Description Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs were judged by investigator and reported as adverse events were presented.
    Time Frame A4091016: Baseline (Day 1) up to Week 80

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 522 832 788
    Number [participants]
    12
    2.3%
    13
    1.6%
    23
    2.9%
    8. Secondary Outcome
    Title Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
    Description The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104

    Outcome Measure Data

    Analysis Population Description
    ITT population. LOCF method was used to impute missing values. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96 and 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 519 831 785
    Parent Study Baseline
    7.20
    (1.43)
    7.20
    (1.40)
    7.19
    (1.47)
    Change at Week 4
    -4.47
    (2.31)
    -4.47
    (2.41)
    -4.52
    (2.48)
    Change at Week 8
    -4.04
    (2.52)
    -4.19
    (2.44)
    -4.45
    (2.53)
    Change at Week 16
    -3.98
    (2.49)
    -4.08
    (2.47)
    -4.29
    (2.57)
    Change at Week 24
    -3.88
    (2.52)
    -4.03
    (2.49)
    -4.17
    (2.62)
    Change at Week 32
    -3.76
    (2.56)
    -3.95
    (2.56)
    -4.10
    (2.64)
    Change at Week 40
    -3.73
    (2.59)
    -3.90
    (2.56)
    -4.07
    (2.66)
    Change at Week 48
    -3.71
    (2.60)
    -3.87
    (2.55)
    -4.05
    (2.66)
    Change at Week 56
    -3.72
    (2.59)
    -3.87
    (2.55)
    -4.03
    (2.67)
    Change at Week 64
    -3.71
    (2.60)
    -3.86
    (2.56)
    -4.02
    (2.67)
    Change at Week 72
    -3.71
    (2.60)
    -3.87
    (2.55)
    -4.02
    (2.67)
    9. Secondary Outcome
    Title Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
    Description The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC physical function score is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104

    Outcome Measure Data

    Analysis Population Description
    ITT population. LOCF method was used to impute missing values. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96 and 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 518 830 784
    Parent Study Baseline
    6.75
    (1.62)
    6.81
    (1.57)
    6.81
    (1.61)
    Change at Week 4
    -3.93
    (2.39)
    -4.05
    (2.38)
    -4.10
    (2.44)
    Change at Week 8
    -3.47
    (2.59)
    -3.75
    (2.45)
    -4.05
    (2.49)
    Change at Week 16
    -3.45
    (2.57)
    -3.65
    (2.46)
    -3.87
    (2.55)
    Change at Week 24
    -3.34
    (2.60)
    -3.60
    (2.50)
    -3.74
    (2.60)
    Change at Week 32
    -3.21
    (2.65)
    -3.51
    (2.54)
    -3.67
    (2.62)
    Change at Week 40
    -3.18
    (2.66)
    -3.45
    (2.53)
    -3.64
    (2.65)
    Change at Week 48
    -3.15
    (2.66)
    -3.44
    (2.52)
    -3.61
    (2.65)
    Change at Week 56
    -3.16
    (2.65)
    -3.43
    (2.53)
    -3.59
    (2.65)
    Change at Week 64
    -3.16
    (2.65)
    -3.42
    (2.53)
    -3.59
    (2.65)
    Change at Week 72
    -3.16
    (2.66)
    -3.42
    (2.53)
    -3.59
    (2.65)
    10. Secondary Outcome
    Title Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
    Description Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicate worse condition. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104

    Outcome Measure Data

    Analysis Population Description
    ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. "Number Analyzed" = participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 519 829 785
    Parent Study Baseline
    3.45
    (0.58)
    3.43
    (0.60)
    3.45
    (0.60)
    Change at Week 4
    -1.18
    (0.93)
    -1.22
    (0.97)
    -1.22
    (0.99)
    Change at Week 8
    -0.98
    (0.99)
    -1.08
    (0.96)
    -1.17
    (1.00)
    Change at Week 16
    -0.94
    (0.95)
    -1.06
    (0.98)
    -1.10
    (0.99)
    Change at Week 24
    -0.88
    (0.93)
    -1.01
    (0.99)
    -1.03
    (1.05)
    Change at Week 32
    -0.88
    (0.95)
    -1.00
    (1.00)
    -1.01
    (1.06)
    Change at Week 40
    -0.85
    (0.98)
    -0.94
    (1.00)
    -0.97
    (1.07)
    Change at Week 48
    -0.83
    (0.98)
    -0.94
    (1.01)
    -0.97
    (1.08)
    Change at Week 56
    -0.84
    (0.97)
    -0.94
    (1.01)
    -0.96
    (1.08)
    Change at Week 64
    -0.83
    (0.97)
    -0.93
    (1.01)
    -0.96
    (1.09)
    Change at Week 72
    -0.83
    (0.97)
    -0.93
    (1.01)
    -0.96
    (1.09)
    11. Secondary Outcome
    Title Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
    Description OMERACT-OARSI response:>=50 percent(%) improvement from parent study baseline and absolute change from parent study baseline of >=2 units at given week in WOMAC pain or physical function subscale or >=20% improvement from parent study baseline and absolute change from parent study baseline of >=1 unit at given week in at least 2 of following 3 items: 1)WOMAC pain subscale, 2)WOMAC physical function subscale, 3)PGA of osteoarthritis (score: 1-5, higher score=more affected).WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score:0-10, higher score=higher pain/difficulty).
    Time Frame A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783). LOCF method was used to impute missing values. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96 and 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 522 832 788
    Week 4
    86.8
    16.6%
    88.5
    10.6%
    86.0
    10.9%
    Week 8
    80.3
    15.4%
    83.5
    10%
    85.0
    10.8%
    Week 16
    80.1
    15.3%
    83.2
    10%
    82.9
    10.5%
    Week 24
    77.4
    14.8%
    82.0
    9.9%
    81.5
    10.3%
    Week 32
    75.1
    14.4%
    79.9
    9.6%
    80.2
    10.2%
    Week 40
    75.1
    14.4%
    79.3
    9.5%
    79.9
    10.1%
    Week 48
    74.5
    14.3%
    79.4
    9.5%
    79.6
    10.1%
    Week 56
    74.9
    14.3%
    79.3
    9.5%
    79.2
    10.1%
    Week 64
    74.5
    14.3%
    79.2
    9.5%
    79.2
    10.1%
    Week 72
    74.5
    14.3%
    79.2
    9.5%
    79.2
    10.1%
    12. Secondary Outcome
    Title Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
    Description The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104

    Outcome Measure Data

    Analysis Population Description
    ITT population. LOCF method was used to impute missing values. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96 and 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 519 831 785
    Week 4: >=30% reduction
    83.6
    16%
    82.6
    9.9%
    81.3
    10.3%
    Week 4: >=50% reduction
    70.1
    13.4%
    68.7
    8.3%
    69.9
    8.9%
    Week 4: >=70% reduction
    48.2
    9.2%
    50.9
    6.1%
    48.9
    6.2%
    Week 4: >=90% reduction
    21.6
    4.1%
    23.1
    2.8%
    24.2
    3.1%
    Week 8: >=30% reduction
    75.5
    14.5%
    78.6
    9.4%
    81.4
    10.3%
    Week 8: >=50% reduction
    64.0
    12.3%
    63.9
    7.7%
    68.3
    8.7%
    Week 8: >=70% reduction
    41.6
    8%
    43.2
    5.2%
    48.2
    6.1%
    Week 8: >=90% reduction
    18.9
    3.6%
    20.7
    2.5%
    25.4
    3.2%
    Week 16: >=30% reduction
    76.5
    14.7%
    76.9
    9.2%
    79.7
    10.1%
    Week 16: >=50% reduction
    63.0
    12.1%
    61.4
    7.4%
    66.5
    8.4%
    Week 16: >=70% reduction
    39.1
    7.5%
    42.0
    5%
    45.7
    5.8%
    Week 16: >=90% reduction
    18.1
    3.5%
    18.8
    2.3%
    21.8
    2.8%
    Week 24: >=30% reduction
    73.6
    14.1%
    77.4
    9.3%
    77.1
    9.8%
    Week 24: >=50% reduction
    60.3
    11.6%
    61.6
    7.4%
    63.3
    8%
    Week 24: >=70% reduction
    38.3
    7.3%
    40.3
    4.8%
    45.5
    5.8%
    Week 24: >=90% reduction
    16.8
    3.2%
    19.3
    2.3%
    21.5
    2.7%
    Week 32: >=30% reduction
    72.6
    13.9%
    75.5
    9.1%
    75.9
    9.6%
    Week 32: >=50% reduction
    57.4
    11%
    59.8
    7.2%
    62.7
    8%
    Week 32: >=70% reduction
    36.8
    7%
    42.2
    5.1%
    43.8
    5.6%
    Week 32: >=90% reduction
    16.6
    3.2%
    19.1
    2.3%
    20.4
    2.6%
    Week 40: >=30% reduction
    71.5
    13.7%
    74.4
    8.9%
    75.9
    9.6%
    Week 40: >=50% reduction
    57.0
    10.9%
    58.1
    7%
    61.7
    7.8%
    Week 40: >=70% reduction
    37.0
    7.1%
    41.2
    5%
    43.8
    5.6%
    Week 40: >=90% reduction
    15.8
    3%
    19.4
    2.3%
    19.7
    2.5%
    Week 48: >=30% reduction
    71.1
    13.6%
    73.9
    8.9%
    75.4
    9.6%
    Week 48: >=50% reduction
    56.6
    10.8%
    58.5
    7%
    61.4
    7.8%
    Week 48: >=70% reduction
    35.8
    6.9%
    40.0
    4.8%
    43.4
    5.5%
    Week 48: >=90% reduction
    15.4
    3%
    18.3
    2.2%
    19.5
    2.5%
    Week 56: >=30% reduction
    71.5
    13.7%
    73.8
    8.9%
    75.2
    9.5%
    Week 56: >=50% reduction
    57.0
    10.9%
    58.1
    7%
    61.1
    7.8%
    Week 56: >=70% reduction
    36.0
    6.9%
    39.8
    4.8%
    43.2
    5.5%
    Week 56: >=90% reduction
    15.6
    3%
    19.0
    2.3%
    19.2
    2.4%
    Week 64: >=30% reduction
    71.3
    13.7%
    73.8
    8.9%
    75.2
    9.5%
    Week 64: >=50% reduction
    56.8
    10.9%
    58.2
    7%
    61.1
    7.8%
    Week 64: >=70% reduction
    36.2
    6.9%
    39.8
    4.8%
    43.2
    5.5%
    Week 64: >=90% reduction
    15.6
    3%
    19.0
    2.3%
    19.2
    2.4%
    Week 72: >=30% reduction
    71.3
    13.7%
    73.8
    8.9%
    75.2
    9.5%
    Week 72: >=50% reduction
    56.8
    10.9%
    58.2
    7%
    61.0
    7.7%
    Week 72: >=70% reduction
    36.2
    6.9%
    39.8
    4.8%
    43.1
    5.5%
    Week 72: >=90% reduction
    15.6
    3%
    19.0
    2.3%
    19.2
    2.4%
    13. Secondary Outcome
    Title Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
    Description The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104

    Outcome Measure Data

    Analysis Population Description
    ITT population. LOCF method was used to impute missing values. "Overall number of participants analyzed" signifies those participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 519 831 785
    Week 16: Greater than 0% reduction
    478
    91.6%
    782
    94%
    733
    93%
    Week 16: >=10% reduction
    462
    88.5%
    750
    90.1%
    708
    89.8%
    Week 16: >=20% reduction
    431
    82.6%
    701
    84.3%
    665
    84.4%
    Week 16: >=30% reduction
    397
    76.1%
    639
    76.8%
    626
    79.4%
    Week 16: >=40% reduction
    358
    68.6%
    573
    68.9%
    577
    73.2%
    Week 16: >=50% reduction
    327
    62.6%
    510
    61.3%
    522
    66.2%
    Week 16: >=60% reduction
    267
    51.1%
    432
    51.9%
    453
    57.5%
    Week 16: >=70% reduction
    203
    38.9%
    349
    41.9%
    359
    45.6%
    Week 16: >=80% reduction
    149
    28.5%
    264
    31.7%
    271
    34.4%
    Week 16: >=90 reduction
    94
    18%
    156
    18.8%
    171
    21.7%
    Week 16: 100% reduction
    30
    5.7%
    68
    8.2%
    78
    9.9%
    Week 24: Greater than 0% reduction
    477
    91.4%
    782
    94%
    734
    93.1%
    Week 24: >=10% reduction
    457
    87.5%
    750
    90.1%
    703
    89.2%
    Week 24: >=20% reduction
    419
    80.3%
    692
    83.2%
    655
    83.1%
    Week 24: >=30% reduction
    382
    73.2%
    643
    77.3%
    605
    76.8%
    Week 24: >=40% reduction
    352
    67.4%
    567
    68.1%
    552
    70.1%
    Week 24: >=50% reduction
    313
    60%
    512
    61.5%
    497
    63.1%
    Week 24: >=60% reduction
    264
    50.6%
    425
    51.1%
    432
    54.8%
    Week 24: >=70% reduction
    199
    38.1%
    335
    40.3%
    357
    45.3%
    Week 24: >=80% reduction
    141
    27%
    255
    30.6%
    271
    34.4%
    Week 24: >=90% reduction
    87
    16.7%
    160
    19.2%
    169
    21.4%
    Week 24: 100% reduction
    29
    5.6%
    69
    8.3%
    66
    8.4%
    Week 56: Greater than 0% reduction
    470
    90%
    773
    92.9%
    726
    92.1%
    Week 56: >=10% reduction
    449
    86%
    735
    88.3%
    689
    87.4%
    Week 56: >=20% reduction
    409
    78.4%
    677
    81.4%
    640
    81.2%
    Week 56: >=30% reduction
    371
    71.1%
    613
    73.7%
    590
    74.9%
    Week 56: >=40% reduction
    334
    64%
    545
    65.5%
    538
    68.3%
    Week 56: >=50% reduction
    296
    56.7%
    483
    58.1%
    480
    60.9%
    Week 56: >=60% reduction
    249
    47.7%
    404
    48.6%
    414
    52.5%
    Week 56: >=70% reduction
    187
    35.8%
    331
    39.8%
    339
    43%
    Week 56: >=80% reduction
    128
    24.5%
    250
    30%
    255
    32.4%
    Week 56: >=90% reduction
    81
    15.5%
    158
    19%
    151
    19.2%
    Week 56: 100% reduction
    30
    5.7%
    63
    7.6%
    69
    8.8%
    14. Secondary Outcome
    Title Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
    Description Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicated worse pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104

    Outcome Measure Data

    Analysis Population Description
    ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. "Number Analyzed" = participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 519 829 785
    Week 4
    37.6
    7.2%
    36.6
    4.4%
    37.3
    4.7%
    Week 8
    28.9
    5.5%
    31.0
    3.7%
    34.9
    4.4%
    Week 16
    29.9
    5.7%
    30.8
    3.7%
    31.7
    4%
    Week 24
    25.8
    4.9%
    28.7
    3.4%
    32.4
    4.1%
    Week 32
    25.8
    4.9%
    28.3
    3.4%
    31.0
    3.9%
    Week 40
    25.4
    4.9%
    26.1
    3.1%
    29.9
    3.8%
    Week 48
    24.7
    4.7%
    26.7
    3.2%
    30.3
    3.8%
    Week 56
    24.7
    4.7%
    26.5
    3.2%
    30.2
    3.8%
    Week 64
    24.7
    4.7%
    26.3
    3.2%
    30.1
    3.8%
    Week 72
    24.7
    4.7%
    26.3
    3.2%
    30.1
    3.8%
    15. Secondary Outcome
    Title Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
    Description WOMAC stiffness subscale: questionnaire used to assess amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. The WOMAC stiffness score is calculated as mean of scores from 2 individual questions scored on NRS of 0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score =0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Stiffness is defined as sensation of decreased ease in movement of knee/hip. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104

    Outcome Measure Data

    Analysis Population Description
    ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 519 831 785
    Parent Study Baseline
    7.00
    (1.83)
    7.06
    (1.78)
    7.05
    (1.85)
    Change at Week 4
    -4.14
    (2.66)
    -4.29
    (2.63)
    -4.36
    (2.73)
    Change at Week 8
    -3.69
    (2.81)
    -4.00
    (2.71)
    -4.33
    (2.76)
    Change at Week 16
    -3.56
    (2.83)
    -3.85
    (2.70)
    -4.10
    (2.84)
    Change at Week 24
    -3.46
    (2.78)
    -3.81
    (2.71)
    -4.02
    (2.91)
    Change at Week 32
    -3.35
    (2.83)
    -3.73
    (2.76)
    -3.91
    (2.95)
    Change at Week 40
    -3.29
    (2.86)
    -3.65
    (2.79)
    -3.90
    (2.95)
    Change at Week 48
    -3.25
    (2.87)
    -3.64
    (2.77)
    -3.87
    (2.96)
    Change at Week 56
    -3.27
    (2.85)
    -3.63
    (2.77)
    -3.85
    (2.96)
    Change at Week 64
    -3.26
    (2.86)
    -3.63
    (2.77)
    -3.85
    (2.96)
    Change at Week 72
    -3.26
    (2.86)
    -3.63
    (2.77)
    -3.85
    (2.96)
    16. Secondary Outcome
    Title Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
    Description WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (minimum difficulty) to 10 (maximum difficulty), where higher score indicates worse response. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104

    Outcome Measure Data

    Analysis Population Description
    ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 519 831 785
    Parent Study Baseline
    6.98
    (1.44)
    7.02
    (1.43)
    7.01
    (1.46)
    Change at Week 4
    -4.18
    (2.31)
    -4.27
    (2.33)
    -4.33
    (2.41)
    Change at Week 8
    -3.74
    (2.49)
    -3.98
    (2.39)
    -4.28
    (2.45)
    Change at Week 16
    -3.67
    (2.49)
    -3.86
    (2.40)
    -4.09
    (2.51)
    Change at Week 24
    -3.57
    (2.50)
    -3.81
    (2.42)
    -3.98
    (2.57)
    Change at Week 32
    -3.45
    (2.55)
    -3.73
    (2.48)
    -3.89
    (2.60)
    Change at Week 40
    -3.41
    (2.57)
    -3.67
    (2.49)
    -3.87
    (2.61)
    Change at Week 48
    -3.38
    (2.58)
    -3.65
    (2.47)
    -3.85
    (2.62)
    Change at Week 56
    -3.39
    (2.57)
    -3.64
    (2.47)
    -3.83
    (2.62)
    Change at Week 64
    -3.39
    (2.58)
    -3.64
    (2.48)
    -3.82
    (2.63)
    Change at Week 72
    -3.38
    (2.58)
    -3.64
    (2.48)
    -3.82
    (2.62)
    17. Secondary Outcome
    Title Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
    Description Participants answered: "How much pain have you had going up or down the stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104

    Outcome Measure Data

    Analysis Population Description
    ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. "Number Analyzed" = participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 518 830 785
    Parent Study Baseline
    8.14
    (1.48)
    8.11
    (1.48)
    8.16
    (1.51)
    Change at Week 4
    -4.60
    (2.61)
    -4.54
    (2.74)
    -4.73
    (2.74)
    Change at Week 8
    -4.15
    (2.83)
    -4.25
    (2.75)
    -4.69
    (2.83)
    Change at Week 16
    -4.01
    (2.79)
    -4.05
    (2.85)
    -4.46
    (2.84)
    Change at Week 24
    -3.85
    (2.86)
    -3.97
    (2.86)
    -4.33
    (2.91)
    Change at Week 32
    -3.76
    (2.87)
    -3.87
    (2.91)
    -4.24
    (2.92)
    Change at Week 40
    -3.70
    (2.92)
    -3.81
    (2.93)
    -4.21
    (2.94)
    Change at Week 48
    -3.72
    (2.88)
    -3.78
    (2.93)
    -4.19
    (2.95)
    Change at Week 56
    -3.74
    (2.86)
    -3.80
    (2.94)
    -4.16
    (2.94)
    Change at Week 64
    -3.75
    (2.87)
    -3.79
    (2.94)
    -4.16
    (2.94)
    Change at Week 72
    -3.74
    (2.87)
    -3.79
    (2.94)
    -4.15
    (2.95)
    18. Secondary Outcome
    Title Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
    Description 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. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
    Time Frame Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104

    Outcome Measure Data

    Analysis Population Description
    ITT population. LOCF method was used to impute missing values. '"Overall number of participants analyzed" = participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 519 831 785
    Parent Study Baseline
    7.22
    (1.67)
    7.10
    (1.63)
    7.10
    (1.66)
    Change at Week 4
    -4.51
    (2.54)
    -4.36
    (2.59)
    -4.38
    (2.67)
    Change at Week 8
    -4.07
    (2.78)
    -4.03
    (2.65)
    -4.24
    (2.73)
    Change at Week 16
    -3.96
    (2.74)
    -3.85
    (2.74)
    -4.12
    (2.84)
    Change at Week 24
    -3.88
    (2.79)
    -3.83
    (2.72)
    -3.97
    (2.85)
    Change at Week 32
    -3.74
    (2.78)
    -3.77
    (2.78)
    -3.88
    (2.87)
    Change at Week 40
    -3.70
    (2.83)
    -3.68
    (2.80)
    -3.86
    (2.89)
    Change at Week 48
    -3.72
    (2.82)
    -3.65
    (2.78)
    -3.83
    (2.90)
    Change at Week 56
    -3.71
    (2.81)
    -3.66
    (2.78)
    -3.81
    (2.91)
    Change at Week 64
    -3.72
    (2.82)
    -3.65
    (2.79)
    -3.80
    (2.91)
    Change at Week 72
    -3.71
    (2.82)
    -3.65
    (2.79)
    -3.80
    (2.91)
    19. Secondary Outcome
    Title Percentage of Participants Who Used Concomitant Analgesic Medication
    Description United States Food and Drug Administration (FDA) approved analgesics (over-the-counter or prescription) 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, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed as per investigator's discretion.
    Time Frame Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112

    Outcome Measure Data

    Analysis Population Description
    ITT population. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 73-80, 81-88, 89-96, 97-104 and 105-112 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 522 832 788
    Week 1-4
    31.8
    6.1%
    28.7
    3.4%
    31.1
    3.9%
    Week 5-8
    33.2
    6.4%
    35.4
    4.3%
    32.1
    4.1%
    Week 9-16
    39.5
    7.6%
    44.4
    5.3%
    45.3
    5.7%
    Week 17-24
    40.4
    7.7%
    43.4
    5.2%
    47.5
    6%
    Week 25-32
    40.7
    7.8%
    34.1
    4.1%
    30.9
    3.9%
    Week 33-40
    36.0
    6.9%
    26.4
    3.2%
    35.3
    4.5%
    Week 41-48
    42.3
    8.1%
    19.1
    2.3%
    34.7
    4.4%
    Week 49-56
    37.2
    7.1%
    34.0
    4.1%
    16.0
    2%
    Week 57-64
    11.0
    2.1%
    28.1
    3.4%
    31.6
    4%
    Week 65-72
    10.3
    2%
    4.7
    0.6%
    16.7
    2.1%
    20. Secondary Outcome
    Title Days Per Week of Concomitant Analgesic Medication Usage
    Description FDA approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, NSAIDs, capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed at the discretion of the investigator.
    Time Frame Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112

    Outcome Measure Data

    Analysis Population Description
    ITT population. 'Number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 73-80, 81-88, 89-96, 97-104 and 105-112 were not reported.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 522 832 788
    Week 1-4
    1.8
    (2.98)
    1.6
    (2.83)
    1.7
    (2.85)
    Week 5-8
    2.0
    (3.13)
    1.9
    (3.06)
    1.9
    (3.05)
    Week 9-16
    2.1
    (3.09)
    2.0
    (3.07)
    1.9
    (3.00)
    Week 17-24
    1.8
    (2.93)
    1.7
    (2.84)
    1.6
    (2.74)
    Week 25-32
    1.7
    (2.89)
    1.4
    (2.64)
    1.3
    (2.58)
    Week 33-40
    1.6
    (2.80)
    1.1
    (2.33)
    1.0
    (2.31)
    Week 41-48
    1.3
    (2.59)
    0.8
    (2.08)
    0.7
    (1.94)
    Week 49-56
    0.9
    (2.03)
    0.8
    (2.05)
    0.5
    (1.59)
    Week 57-64
    0.5
    (1.66)
    0.4
    (1.39)
    0.2
    (0.67)
    Week 65-72
    0.3
    (0.97)
    0.0
    (0.19)
    0.2
    (1.13)
    21. Other Pre-specified Outcome
    Title Number of Participants Classified According to Number of Intravenous Doses of Study Medication
    Description Number of participants were reported based on the maximum number of intravenous doses of either tanezumab or placebo received.
    Time Frame A4091016: Baseline (Day 1) up to Week 64

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    Measure Participants 522 832 788
    1 dose
    39
    7.5%
    81
    9.7%
    69
    8.8%
    2 doses
    91
    17.4%
    161
    19.4%
    164
    20.8%
    3 doses
    92
    17.6%
    172
    20.7%
    177
    22.5%
    4 doses
    78
    14.9%
    158
    19%
    141
    17.9%
    5 doses
    81
    15.5%
    104
    12.5%
    121
    15.4%
    6 doses
    76
    14.6%
    79
    9.5%
    62
    7.9%
    7 doses
    49
    9.4%
    59
    7.1%
    41
    5.2%
    8 doses
    13
    2.5%
    13
    1.6%
    11
    1.4%
    9 doses
    3
    0.6%
    5
    0.6%
    2
    0.3%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Participants may have experienced both non serious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
    Arm/Group Title Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Arm/Group Description Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
    All Cause Mortality
    Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 47/522 (9%) 73/832 (8.8%) 96/788 (12.2%)
    Blood and lymphatic system disorders
    Anaemia 1/522 (0.2%) 0/832 (0%) 2/788 (0.3%)
    Microcytic anaemia 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Cardiac disorders
    Acute coronary syndrome 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Acute myocardial infarction 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Angina pectoris 0/522 (0%) 1/832 (0.1%) 1/788 (0.1%)
    Angina unstable 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Atrial fibrillation 1/522 (0.2%) 3/832 (0.4%) 1/788 (0.1%)
    Bradycardia 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Cardiac arrest 1/522 (0.2%) 1/832 (0.1%) 0/788 (0%)
    Cardiac failure congestive 0/522 (0%) 2/832 (0.2%) 0/788 (0%)
    Coronary artery disease 2/522 (0.4%) 3/832 (0.4%) 1/788 (0.1%)
    Coronary artery occlusion 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Coronary artery stenosis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Myocardial infarction 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Myocardial ischaemia 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Supraventricular tachycardia 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Ventricular failure 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Gastrointestinal disorders
    Abdominal mass 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Abdominal pain upper 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Colitis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Diarrhoea 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Diverticulum intestinal haemorrhagic 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Enterovesical fistula 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Femoral hernia 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Gastric ulcer 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Gastritis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Gastrointestinal haemorrhage 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Ileus paralytic 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Intestinal ischaemia 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Intestinal obstruction 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Small intestinal obstruction 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Small intestinal perforation 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Upper gastrointestinal haemorrhage 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    General disorders
    Chest discomfort 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Chest pain 1/522 (0.2%) 1/832 (0.1%) 3/788 (0.4%)
    Oedema 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Pyrexia 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Hepatobiliary disorders
    Cholecystitis 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Cholecystitis acute 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Cholelithiasis 0/522 (0%) 0/832 (0%) 2/788 (0.3%)
    Hepatitis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Infections and infestations
    Abscess limb 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Appendicitis 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Arthritis bacterial 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Bacteraemia 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Cellulitis 1/522 (0.2%) 0/832 (0%) 2/788 (0.3%)
    Diverticulitis 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Endocarditis 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Gastroenteritis viral 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Haematoma infection 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Infective exacerbation of chronic obstructive airways disease 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Mastitis 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Osteomyelitis 0/522 (0%) 0/832 (0%) 2/788 (0.3%)
    Pneumonia 0/522 (0%) 0/832 (0%) 2/788 (0.3%)
    Post procedural infection 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Pulmonary mycosis 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Sepsis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Staphylococcal infection 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Urinary tract infection 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Urosepsis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Injury, poisoning and procedural complications
    Acetabulum fracture 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Ankle fracture 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Clavicle fracture 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Concussion 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Fall 0/522 (0%) 0/832 (0%) 2/788 (0.3%)
    Femur fracture 0/522 (0%) 0/832 (0%) 2/788 (0.3%)
    Foot fracture 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Foreign body 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Hip fracture 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Ligament rupture 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Lower limb fracture 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Lumbar vertebral fracture 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Meniscus lesion 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Pelvic fracture 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Post procedural haematoma 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Skeletal injury 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Spinal fracture 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Tendon rupture 0/522 (0%) 1/832 (0.1%) 2/788 (0.3%)
    Tibia fracture 0/522 (0%) 1/832 (0.1%) 2/788 (0.3%)
    Ulna fracture 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Upper limb fracture 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Investigations
    Alanine aminotransferase increased 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Aspartate aminotransferase increased 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Blood glucose increased 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Blood urea increased 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    White blood cell count increased 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Metabolism and nutrition disorders
    Dehydration 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Hypernatraemia 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Hyperosmolar state 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Hypokalaemia 1/522 (0.2%) 1/832 (0.1%) 0/788 (0%)
    Hyponatraemia 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Type 2 diabetes mellitus 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 4/522 (0.8%) 5/832 (0.6%) 6/788 (0.8%)
    Arthritis 0/522 (0%) 2/832 (0.2%) 3/788 (0.4%)
    Back pain 0/522 (0%) 2/832 (0.2%) 0/788 (0%)
    Chondrolysis 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Intervertebral disc degeneration 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Intervertebral disc protrusion 0/522 (0%) 0/832 (0%) 2/788 (0.3%)
    Joint swelling 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Kyphosis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Lumbar spinal stenosis 1/522 (0.2%) 0/832 (0%) 1/788 (0.1%)
    Musculoskeletal pain 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Osteoarthritis 9/522 (1.7%) 22/832 (2.6%) 25/788 (3.2%)
    Osteonecrosis 6/522 (1.1%) 9/832 (1.1%) 13/788 (1.6%)
    Scoliosis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Spinal column stenosis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 2/522 (0.4%) 0/832 (0%) 0/788 (0%)
    Breast cancer 0/522 (0%) 2/832 (0.2%) 2/788 (0.3%)
    Carcinoid tumour pulmonary 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Colon cancer 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Glioblastoma 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Hepatic neoplasm malignant 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Lung squamous cell carcinoma stage unspecified 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Malignant melanoma 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Metastases to lymph nodes 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Multiple myeloma 1/522 (0.2%) 1/832 (0.1%) 0/788 (0%)
    Oesophageal adenocarcinoma 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Oesophageal cancer metastatic 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Prostate cancer 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Squamous cell carcinoma 2/522 (0.4%) 0/832 (0%) 0/788 (0%)
    Uterine cancer 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Vaginal cancer 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Nervous system disorders
    Carotid artery occlusion 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Carotid artery stenosis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Cerebrovascular accident 0/522 (0%) 0/832 (0%) 3/788 (0.4%)
    Headache 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Hydrocephalus 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Ischaemic cerebral infarction 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Sciatica 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Psychiatric disorders
    Depression 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Suicidal ideation 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Suicide attempt 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Renal and urinary disorders
    Haematuria 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Renal failure acute 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Cystocele 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Rectocele 0/522 (0%) 1/832 (0.1%) 0/788 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Pulmonary embolism 0/522 (0%) 2/832 (0.2%) 3/788 (0.4%)
    Pulmonary thrombosis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Respiratory failure 1/522 (0.2%) 0/832 (0%) 0/788 (0%)
    Vascular disorders
    Deep vein thrombosis 0/522 (0%) 3/832 (0.4%) 1/788 (0.1%)
    Haemorrhage 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Temporal arteritis 0/522 (0%) 0/832 (0%) 1/788 (0.1%)
    Other (Not Including Serious) Adverse Events
    Tanezumab 2.5 mg Tanezumab 5 mg Tanezumab 10 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 280/522 (53.6%) 412/832 (49.5%) 408/788 (51.8%)
    Gastrointestinal disorders
    Diarrhoea 7/522 (1.3%) 18/832 (2.2%) 8/788 (1%)
    General disorders
    Oedema peripheral 22/522 (4.2%) 52/832 (6.3%) 57/788 (7.2%)
    Infections and infestations
    Bronchitis 8/522 (1.5%) 9/832 (1.1%) 16/788 (2%)
    Nasopharyngitis 14/522 (2.7%) 19/832 (2.3%) 18/788 (2.3%)
    Sinusitis 15/522 (2.9%) 26/832 (3.1%) 21/788 (2.7%)
    Upper respiratory tract infection 36/522 (6.9%) 42/832 (5%) 29/788 (3.7%)
    Urinary tract infection 29/522 (5.6%) 57/832 (6.9%) 42/788 (5.3%)
    Injury, poisoning and procedural complications
    Contusion 12/522 (2.3%) 10/832 (1.2%) 17/788 (2.2%)
    Fall 26/522 (5%) 23/832 (2.8%) 40/788 (5.1%)
    Muscle strain 12/522 (2.3%) 12/832 (1.4%) 19/788 (2.4%)
    Investigations
    Blood creatine phosphokinase increased 15/522 (2.9%) 14/832 (1.7%) 13/788 (1.6%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 73/522 (14%) 116/832 (13.9%) 121/788 (15.4%)
    Back pain 20/522 (3.8%) 22/832 (2.6%) 37/788 (4.7%)
    Joint effusion 8/522 (1.5%) 18/832 (2.2%) 18/788 (2.3%)
    Joint swelling 27/522 (5.2%) 37/832 (4.4%) 53/788 (6.7%)
    Muscle spasms 11/522 (2.1%) 15/832 (1.8%) 11/788 (1.4%)
    Musculoskeletal pain 27/522 (5.2%) 38/832 (4.6%) 32/788 (4.1%)
    Osteoarthritis 33/522 (6.3%) 50/832 (6%) 46/788 (5.8%)
    Pain in extremity 31/522 (5.9%) 37/832 (4.4%) 45/788 (5.7%)
    Synovial cyst 6/522 (1.1%) 12/832 (1.4%) 17/788 (2.2%)
    Nervous system disorders
    Carpal tunnel syndrome 8/522 (1.5%) 12/832 (1.4%) 20/788 (2.5%)
    Headache 23/522 (4.4%) 23/832 (2.8%) 13/788 (1.6%)
    Hypoaesthesia 22/522 (4.2%) 42/832 (5%) 50/788 (6.3%)
    Paraesthesia 20/522 (3.8%) 59/832 (7.1%) 59/788 (7.5%)
    Respiratory, thoracic and mediastinal disorders
    Cough 11/522 (2.1%) 8/832 (1%) 9/788 (1.1%)

    Limitations/Caveats

    Due to FDA imposed clinical hold, enrollment was stopped prematurely and, therefore, not all study procedures and visits occurred as planned.

    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
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00809783
    Other Study ID Numbers:
    • A4091016
    • P3 LONG TERM SAFETY EXTENSION
    First Posted:
    Dec 17, 2008
    Last Update Posted:
    May 10, 2021
    Last Verified:
    Apr 1, 2021