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| ID | Type | Description | Link |
|---|---|---|---|
| P3 LONG TERM SAFETY EXTENSION | Other Identifier | Alias Study Number |
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See termination reason in detailed description.
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Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tanezumab 10 mg | Experimental | Tanezumab 10 mg |
|
| Tanezumab 5 mg | Experimental | Tanezumab 5 mg |
|
| Tanezumab 2.5 mg | Experimental | Tanezumab 2.5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tanezumab | Biological | Tanezumab 10 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | 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. | A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80) |
| Number of Participants With Abnormal Laboratory Findings | 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). | A4091016: Day 1 up to Week 80 |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Classified According to Number of Intravenous Doses of Study Medication | Number of participants were reported based on the maximum number of intravenous doses of either tanezumab or placebo received. | A4091016: Baseline (Day 1) up to Week 64 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinncale Research Group, LLC | Anniston | Alabama | 36201 | United States | ||
| Anniston Medical Clinic, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26554876 | Derived | Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tanezumab 2.5 mg | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
| FG001 | Tanezumab 5 mg | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| tanezumab | Biological | Tanezumab 5 mg |
|
|
| tanezumab | Biological | Tanezumab 2.5 mg |
|
|
| A4091016: Baseline (Day 1) up to Week 80 |
| Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
| Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab | 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. | A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80) |
| Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings | 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. | Baseline (Day 1) up to Week 80 |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | 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. | A4091016: Baseline (Day 1) up to Week 80 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | 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). | A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104 |
| Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score | 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. | 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 |
| 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 | 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. | Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104 |
| Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| 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 | 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. | 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 |
| Percentage of Participants Who Used Concomitant Analgesic Medication | 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. | 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 |
| Days Per Week of Concomitant Analgesic Medication Usage | 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. | 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 |
| Anniston |
| Alabama |
| 36207 |
| United States |
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States |
| Greystone Medical Center | Birmingham | Alabama | 35242 | United States |
| Saadat Ansari, MD Office | Huntsville | Alabama | 35801 | United States |
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | United States |
| Horizon Research Group | Mobile | Alabama | 36608 | United States |
| Clinical Research Advantage, Inc./Mesa Family Medical Center, PC | Mesa | Arizona | 85203 | United States |
| Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC | Mesa | Arizona | 85206 | United States |
| Novara Clinical Research | Mesa | Arizona | 85206 | United States |
| Clinical Research Advantage, Inc. | Mesa | Arizona | 85213 | United States |
| Arizona Arthritis & Rheumatology Research, PLLC | Paradise Valley | Arizona | 85253 | United States |
| Pivotal Research Center | Peoria | Arizona | 85381 | United States |
| Clincial Research Advantage, Inc/Central Phoenix Medical Clinic, LLC | Phoenix | Arizona | 85020 | United States |
| Arizona Research Center | Phoenix | Arizona | 85023 | United States |
| Clinical Research Advantage, Inc. | Phoenix | Arizona | 85028 | United States |
| Arizona Arthritis & Rheumatology Associates, P.C. | Phoenix | Arizona | 85037 | United States |
| Paradigm Clinical, Inc. | Tucson | Arizona | 85712 | United States |
| Quality of Life Medical & Research Center, LLC | Tucson | Arizona | 85712 | United States |
| Quality of Life Medical and Research Center | Tucson | Arizona | 85712 | United States |
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | United States |
| University of Arizona | Tucson | Arizona | 85724 | United States |
| St. Joseph's Mercy Clinic | Hot Springs | Arkansas | 71913 | United States |
| Osteoporosis Medical Center | Beverly Hills | California | 90211 | United States |
| Providence Clinical Research | Burbank | California | 91505 | United States |
| eStudySite | Chula Vista | California | 91911 | United States |
| Colorado Hematology - Oncology | Englewood | California | 80110 | United States |
| Colorado Orthopedic Consultants, PC | Englewood | California | 80110 | United States |
| Arthritis Medical Clinic of North County, Inc. | Escondido | California | 92025 | United States |
| Edinger Medical Group Clinical Research | Fountain Valley | California | 92708 | United States |
| Valley Research | Fresno | California | 93720 | United States |
| Talbert Medical Group | Huntington Beach | California | 92646 | United States |
| Lakewood Orthopedic Medical & Surgical Group | Lakewood | California | 90712 | United States |
| High Desert Medical Group Research for Life | Lancaster | California | 93534 | United States |
| Premiere Clinical Research, LLC | Long Beach | California | 90807 | United States |
| Samaritan Center for Medical Research | Los Gatos | California | 95032 | United States |
| Del Carmen Medical Center | Reseda | California | 91335 | United States |
| Probe Clinical Research, Corp. | Santa Ana | California | 92701 | United States |
| Trinity Clinical Trials | Santa Ana | California | 92701 | United States |
| Office of Lawrence P McAdam, MD | Thousand Oaks | California | 91360 | United States |
| Westlake Medical Research | Westlake Village | California | 91361 | United States |
| Colorado Orthopedic Consultants, PC | Aurora | Colorado | 80012 | United States |
| Peak Anesthesia and Pain Management | Centennial | Colorado | 80112 | United States |
| Denver Internal Medicine Group | Denver | Colorado | 80209 | United States |
| Mountain View Clinical Research, Inc. | Denver | Colorado | 80209 | United States |
| Advanced Orthopedic and Sports Medicine | Denver | Colorado | 80230 | United States |
| American Clinical Research, LLC | Englewood | Colorado | 80113 | United States |
| Orthopaedic Physicians Of Colorado, P.C. | Englewood | Colorado | 80113 | United States |
| University Parks Hematology/Oncology | Englewood | Colorado | 80113 | United States |
| Advanced Orthopedic and Sports Medicine | Parker | Colorado | 80134 | United States |
| Clinical Research Center of Connecticut | Danbury | Connecticut | 06810 | United States |
| Norwalk Medical Group | Norwalk | Connecticut | 06851 | United States |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | United States |
| Delaware Arthritis | Lewes | Delaware | 19958 | United States |
| Javed Rheumatology Associates, Inc. | Newark | Delaware | 19713 | United States |
| HeartCare (Private Practice) | Bradenton | Florida | 34202 | United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| Tampa Bay Medical Research, Inc. | Clearwater | Florida | 33761 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Arthritis Associates of South Florida | Delray Beach | Florida | 33484 | United States |
| Delray Research Associates | Delray Beach | Florida | 33484 | United States |
| In Vivo Clinical Research, Inc | Doral | Florida | 33166 | United States |
| S & W Clinical Research | Fort Lauderdale | Florida | 33306 | United States |
| Centre for Rheumatology, Immunology and Arthritis | Fort Lauderdale | Florida | 33334 | United States |
| Westside Center for Clinical Research | Jacksonville | Florida | 32205 | United States |
| Adult Medicine Specialists | Longwood | Florida | 32779 | United States |
| Genesis Research International | Longwood | Florida | 32779 | United States |
| Pharmax Research Clinic, Inc | Miami | Florida | 33126 | United States |
| Kendall South Medical Center, Inc. | Miami | Florida | 33185 | United States |
| Sunshine Research Center | Opa-locka | Florida | 33054-3818 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Rheumatology Associates of Central Florida | Orlando | Florida | 32806 | United States |
| The Arthritis Center | Palm Harbor | Florida | 34684 | United States |
| University Clinical Research Incorporated | Pembroke Pines | Florida | 33024 | United States |
| Advent Clinical Research Centers, Inc. | Pinellas Park | Florida | 33781 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| HeartCare Research | Sarasota | Florida | 34232 | United States |
| Dale G. Bramlet, MD, P.L. | St. Petersburg | Florida | 33713 | United States |
| West Broward Rheumatology Associates, Inc. | Tamarac | Florida | 33321 | United States |
| Tampa Medical Group, PA | Tampa | Florida | 33614 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Laureate Clinical Research Group | Atlanta | Georgia | 30308 | United States |
| Arthritis and Rheumatology of Georgia | Atlanta | Georgia | 30342 | United States |
| Laureate Clinical Research Group | Atlanta | Georgia | 30342 | United States |
| Masters of Clinical Research, Inc. | Augusta | Georgia | 30909 | United States |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | United States |
| Jefrey D. Lieberman, MD | Decatur | Georgia | 30033 | United States |
| Early Family Practice Center | Fort Valley | Georgia | 31030 | United States |
| Northeast Georgia Diagnostic Clinic, LLC | Gainesville | Georgia | 30501 | United States |
| Marietta Rheumatology Associates | Marietta | Georgia | 30060 | United States |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | United States |
| North Georgia Internal Medicine | Woodstock | Georgia | 30189 | United States |
| Sonora Clinical Research, LLC. | Boise | Idaho | 83702 | United States |
| Millennium Pain Center | Bloomington | Illinois | 61701 | United States |
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
| Koch Family Medicine | Morton | Illinois | 61550 | United States |
| Illinois Bone and Joint Institute, LLC | Morton Grove | Illinois | 60053 | United States |
| The Arthritis Center | Springfield | Illinois | 62704 | United States |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | United States |
| American Health Network | Fishers | Indiana | 46038 | United States |
| Memorial Medical Group Clinical Research Institute | South Bend | Indiana | 46601 | United States |
| Northwest Indiana Center for Clinical Research | Valparaiso | Indiana | 46383 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | 50265 | United States |
| Professional Research Network of Kansas, LLC | Wichita | Kansas | 67203 | United States |
| Pasadena Pharmacy | Lexington | Kentucky | 40503 | United States |
| The Pain Treatment Center of the Bluegrass | Lexington | Kentucky | 40503 | United States |
| Arthritis Center of Lexington | Lexington | Kentucky | 40504 | United States |
| Bluegrass Community Research, Inc | Lexington | Kentucky | 40515 | United States |
| David H. Neustadt, MD | Louisville | Kentucky | 40202 | United States |
| L-Marc Research Center | Louisville | Kentucky | 40213 | United States |
| Bone and Joint Clinic of Baton Rouge | Baton Rouge | Louisiana | 70808 | United States |
| Gulf Coast Research, LLC | Baton Rouge | Louisiana | 70808 | United States |
| The Baton Rouge Clinic | Baton Rouge | Louisiana | 70808 | United States |
| Stanocola Medical Center | Baton Rouge | Louisiana | 70816 | United States |
| Arthritis and Diabetes Clinic | Monroe | Louisiana | 71203 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| Arthritis Treatment Center | Frederick | Maryland | 21702 | United States |
| Mid-Atlantic Medical Research Centers | Hollywood | Maryland | 20636 | United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | 02301 | United States |
| Miray Medical Center | Brockton | Massachusetts | 02301 | United States |
| Mansfield Health Center | Mansfield | Massachusetts | 02048 | United States |
| Arthritis Associates Inc. | Peabody | Massachusetts | 01960 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | United States |
| Ann Arbor Clinical Research | Ann Arbor | Michigan | 48103 | United States |
| Great Lakes Research Group, Incorporated | Bay City | Michigan | 48706 | United States |
| KMED Research | Saint Clair Shores | Michigan | 48081 | United States |
| MAPS Applied Research Center Inc. | Edina | Minnesota | 55435 | United States |
| Medical Advanced Pain Specialists | Edina | Minnesota | 55435 | United States |
| Planters Clinic | Port Gibson | Mississippi | 39150 | United States |
| St. John's Clinic - Neurology | Springfield | Missouri | 65804 | United States |
| St. John's Medical Research Institute, Inc. | Springfield | Missouri | 65807 | United States |
| Medex Healthcare Research | St Louis | Missouri | 63117 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Midwest Minor Medical | Omaha | Nebraska | 68114 | United States |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | United States |
| Midwest Minor Medical | Omaha | Nebraska | 68127 | United States |
| Midwest Minor Medical | Omaha | Nebraska | 68144 | United States |
| Diagnostic Center of Medicine | Henderson | Nevada | 89052 | United States |
| Independent Clinical Researchers | Las Vegas | Nevada | 89103 | United States |
| Wolfson Medical Center | Las Vegas | Nevada | 89103 | United States |
| Clinical Research Consortium | Las Vegas | Nevada | 89119 | United States |
| Mirkil Medical | Las Vegas | Nevada | 89119 | United States |
| G. Timothy Kelly, MD | Las Vegas | Nevada | 89128 | United States |
| Office of Dr. Danka Michaels, MD | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| New Mexico Clinical Research & Osteoporosis Center, Incorporated | Albuquerque | New Mexico | 87106 | United States |
| Arthritis and Osteoporosis Medical Associates | Brooklyn | New York | 11201 | United States |
| Medex Healthcare Research | New York | New York | 10022 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| Prem C. Chatpar, MD, LLC | Plainview | New York | 11803 | United States |
| AAIR Research Center | Rochester | New York | 14618 | United States |
| Office of Dr. Andrew Porges | Roslyn | New York | 11576-1507 | United States |
| SPRI Bronx LLC | The Bronx | New York | 10454 | United States |
| Arthritis and Osteoporosis Consultants of the Carolinas | Charlotte | North Carolina | 28207-1198 | United States |
| Carolina Bone & Joint, PA | Charlotte | North Carolina | 28210 | United States |
| Pharmquest | Greensboro | North Carolina | 27408 | United States |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Odyssey Research | Fargo | North Dakota | 58104 | United States |
| Plains Medical Clinic, LLC | Fargo | North Dakota | 58104 | United States |
| Consultants for Clinical Research Incorporated | Cincinnati | Ohio | 45219 | United States |
| Ohio GI and Liver Institute | Cincinnati | Ohio | 45219 | United States |
| Hilltop Medical Research Center | Cincinnati | Ohio | 45224 | United States |
| Columbus Clinical Research, Inc. | Columbus | Ohio | 43213 | United States |
| PHP Center for Clinical Research | Dayton | Ohio | 45439 | United States |
| Paramount Medical Research and Consulting, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Orthopaedic & Sports Medicine Consultants | Middletown | Ohio | 45042 | United States |
| Signal Point Clinical Research Center | Middletown | Ohio | 45042 | United States |
| Pharmacotherapy Research Associates,Inc | Zanesville | Ohio | 43701 | United States |
| Physicians' Research, Inc | Zanesville | Ohio | 43701 | United States |
| Primecare of Southeastern Ohio, Inc | Zanesville | Ohio | 43701 | United States |
| Cor Clinical Research, LLC | Oklahoma City | Oklahoma | 73103 | United States |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | United States |
| East Penn Rheumatology Associates, PC | Bethlehem | Pennsylvania | 18015-1153 | United States |
| Brandywine Clinical Research | Downingtown | Pennsylvania | 19335-2620 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Clinical Research Center of Reading, LLP | Wyomissing | Pennsylvania | 19610 | United States |
| Low Country Rheumatology, PA | Charleston | South Carolina | 29406 | United States |
| The Family Healthcare Center, PA | Clinton | South Carolina | 29325 | United States |
| Southern Orthopaedic Sports Medicine | Columbia | South Carolina | 29204 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| The Carolina Center for Rheumatology and Arthritis Care, PA | Rock Hill | South Carolina | 29732 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| State of Franklin Healthcare Associates, PLLC | Johnson City | Tennessee | 37604 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Capitol Medical Clinic | Austin | Texas | 78705 | United States |
| Walter F. Chase, MD, PA | Austin | Texas | 78705 | United States |
| Tekton Research, Inc. | Austin | Texas | 78745 | United States |
| North Texas Joint Care, PA | Dallas | Texas | 75230 | United States |
| Crown Imaging | Dallas | Texas | 75231 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Radiant Research | Dallas | Texas | 75231 | United States |
| O. David Taunton, Jr, MD | Grapevine | Texas | 76051 | United States |
| Asif Cochinwala, MD, PA | Houston | Texas | 77008 | United States |
| Foundation for Southwest Orthopedic Research | Houston | Texas | 77030 | United States |
| One Step Diagnostic | Houston | Texas | 77030 | United States |
| Southwest Orthopedic Group | Houston | Texas | 77030 | United States |
| The Neurology Center | Houston | Texas | 77030 | United States |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77036 | United States |
| Gill Orthopedic Center | Lubbock | Texas | 79410 | United States |
| Robert R. King, M.D. | Lubbock | Texas | 79410 | United States |
| Clinical Investigations of Texas, LLC | Plano | Texas | 75075 | United States |
| Radiant Research San Antonio Northeast | San Antonio | Texas | 78217 | United States |
| Texas Arthritis Research Center, PA | San Antonio | Texas | 78217 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| Spring Family Practice Associates PA | Spring | Texas | 77379 | United States |
| AZ Clinical Research | Sugar Land | Texas | 77478 | United States |
| Spring Clinical Research | Sugar Land | Texas | 77478 | United States |
| Sugar Land Med-Ped, P.A. | Sugar Land | Texas | 77479 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| Aspen Clinical Research | Orem | Utah | 84058 | United States |
| Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Incorporated/Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| Commonwealth Orthopaedics and Rehabilitation, PC | Arlington | Virginia | 22205 | United States |
| IntegraTrials, LLC | Arlington | Virginia | 22205 | United States |
| Virginia Hospital Center | Arlington | Virginia | 22205 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| National Clinical Research - Norfolk, Inc. | Norfolk | Virginia | 23502 | United States |
| Office of Doris M. Rice, MD, FACR | Portsmouth | Virginia | 23701 | United States |
| HhypotheTest, LLC | Roanoke | Virginia | 24018 | United States |
| Empirical Clinical Trials | Selah | Washington | 98942 | United States |
| Arthritis Northwest | Spokane | Washington | 99204-2336 | United States |
| Clinical Trials Northwest | Yakima | Washington | 98902 | United States |
| FG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Intent to treat (ITT) analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tanezumab 2.5 mg | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
| BG001 | Tanezumab 5 mg | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
| BG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | 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. | Intent to treat (ITT) analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783). | Posted | Count of Participants | Participants | A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80) |
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| Primary | Number of Participants With Abnormal Laboratory Findings | 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). | 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. | Posted | Count of Participants | Participants | A4091016: Day 1 up to Week 80 |
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| Primary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 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. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783). | Posted | Count of Participants | Participants | A4091016: Baseline (Day 1) up to Week 80 |
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| Secondary | Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 |
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| Secondary | Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab | 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. | 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. | Posted | Count of Participants | Participants | A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80) |
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| Secondary | Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings | 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. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783). | Posted | Count of Participants | Participants | Baseline (Day 1) up to Week 80 |
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| Secondary | Number of Participants With Clinically Significant Abnormality in Vital Signs | 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. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783). | Posted | Number | participants | A4091016: Baseline (Day 1) up to Week 80 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Secondary | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104 |
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| Secondary | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score | 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. | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Count of Participants | Participants | Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104 |
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| Secondary | Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Secondary | Percentage of Participants Who Used Concomitant Analgesic Medication | 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. | 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. | Posted | Number | percentage of participants | 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 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Days Per Week of Concomitant Analgesic Medication Usage | 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. | 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. | Posted | Mean | Standard Deviation | days per week | 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 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Classified According to Number of Intravenous Doses of Study Medication | Number of participants were reported based on the maximum number of intravenous doses of either tanezumab or placebo received. | ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783). | Posted | Count of Participants | Participants | A4091016: Baseline (Day 1) up to Week 64 |
|
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tanezumab 2.5 mg | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. | 47 | 522 | 280 | 522 | ||
| EG001 | Tanezumab 5 mg | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. | 73 | 832 | 412 | 832 | ||
| EG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. | 96 | 788 | 408 | 788 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ventricular failure | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal mass | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Femoral hernia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperosmolar state | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chondrolysis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Carcinoid tumour pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oesophageal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vaginal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Temporal arteritis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Due to FDA imposed clinical hold, enrollment was stopped prematurely and, therefore, not all study procedures and visits occurred as planned.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549319 | tanezumab |
Not provided
Not provided
Not provided
| 45 to 64 years |
|
| Greater than or equal to 65 years |
|
| Male |
|
| Title | Measurements |
|---|---|
|
| Tanezumab 5 mg |
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks.
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
|
|
| Tanezumab 5 mg |
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
|
|
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
|
|
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 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.
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 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.
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
|
|
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 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. |
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 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.
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
|
|
| OG002 | Tanezumab 10 mg | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion administered every 8 weeks for up to 64 weeks. |
|
|
| OG002 |
| Tanezumab 10 mg |
Tanezumab (RN624 or PF-04383119) 10 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. |
|
|
|
|
| Participants |
|
|